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The Orthomedix Group, Inc

The Orthomedix Group, Inc

THE ORTHOMEDIX GROUP, INC.

MEMORANDUM

Date: , 2018 To: Osseus Fusion Systems From: J.D. Webb Subject: Aries Lumbar Interbody – K181347

The Aries Lumbar Interbody has been cleared for marketing by the FDA. The attached list shows the catalogue numbers that were included in this submission. It is important that the exact verbiage of the attached indications are used in all marketing materials and that the attached label and package insert be implemented for the U.S.

I appreciate the opportunity to have aided you in gaining FDA clearance to market your device and look forward to future products that I can help you with.

Sincerely

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 2

Approved Components

Implants FAMILY PART/ASSEMBLY NUMBER PART/ASSEMBLY DESCRIPTION 1100-0000S TSLIF 8x22x7-16, 0°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-0009S 1100-0120S TSLIF 10x24x7-16, 0°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-0129S 1100-0320S TSLIF 10x28x7-16, 0°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-0329S 1100-0520S TSLIF 10x32x7-16, 0°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-0529S 1100-0740S TSLIF 12x36x7-16, 0°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-0749S 1100-1000S TSLIF 8x22x7-16, 7°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-1009S 1100-1120S TSLIF 10x24x7-16, 7°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-1129S 1100-1320S TSLIF 10x28x7-16, 7°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-1329S 1100-1520S TSLIF 10x32x7-16, 7°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-1529S 1100-1742S TSLIF 12x36x9-16, 7°, STERILE, TSLIF INTERBODY, ARIES-TS 1100-1749S 1200-0000S TCLIF 10x25x7-16, 0°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-0009S 1200-0200S TCLIF 10x27x7-16, 0°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-0209S 1200-0700S TCLIF 10x32x7-16, 0°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-0709S 1200-0920S TCLIF 12x34x7-16, 0°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-0929S 1200-1000S TCLIF 10x25x7-16, 7°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-1009S 1200-1200S TCLIF 10x27x7-16, 7°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-1209S 1200-1700S TCLIF 10x32x7-16, 7°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-1709S 1200-1920S TCLIF 12x34x7-16, 7°, STERILE, TCLIF INTERBODY, ARIES-TC 1200-1929S 1400-0000S LLIF 16x40x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0004S 1400-0200S LLIF 20x40x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0204S 1400-0210S LLIF 20x45x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0214S 1400-0220S LLIF 20x50x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0224S 1400-0230S LLIF 20x55x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0234S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 3

1400-0240S LLIF 20x60x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0244S 1400-0440S LLIF 24x60x8-16, 0°, STERILE, LLIF INTERBODY, ARIES-L 1400-0444S 1400-1000S LLIF 16x40x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1004S 1400-1200S LLIF 20x40x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1204S 1400- LLIF 20x45x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1214S 1400- LLIF 20x50x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1224S 1400- LLIF 20x55x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1234S 1400-1240S LLIF 20x60x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1244S 1400-1440S LLIF 24x60x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1444S 1400-2000S LLIF 16x40x8-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2004S 1400-2201S LLIF 20x40x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2204S 1400-2211S LLIF 20x45x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2214S 1400-2221S LLIF 20x50x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2224S 1400-2231S LLIF 20x55x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2234S 1400-2241S LLIF 20x60x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2244S 1400-2441S LLIF 24x60x10-16, 16°, STERILE, LLIF INTERBODY, ARIES-L 1400-2444S 1400-3001S LLIF 16x40x10-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3004S 1400-3202S LLIF 20x40x12-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3204S 1400-3212S LLIF 20x45x12-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3214S 1400-3222S LLIF 20x50x12-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3224S 1400-3232S LLIF 20x55x12-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3234S 1400-3242S LLIF 20x60x12-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3244S 1400-3443S LLIF 24x60x14-16, 24°, STERILE, LLIF INTERBODY, ARIES-L 1400-3444S 1400-4002S LLIF 16x40x12-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4004S 1400-4203S LLIF 20x40x14-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4204S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 4

1400-4213S LLIF 20x45x14-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4214S 1400-4223S LLIF 20x50x14-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4224S 1400-4233S LLIF 20x55x14-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4234S 1400-4243S LLIF 20x60x14-16, 30°, STERILE, LLIF INTERBODY, ARIES-L 1400-4244S

LLIF 1400-4444S 24x60x16, 30°, STERILE, LLIF INTERBODY, ARIES-L

1500-0000S ELIF 10x25x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0009S 1500-0010S ELIF 10x30x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0019S 1500-0020S ELIF 10x35x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0029S 1500-0030S ELIF 10x40x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0039S 1500-0040S ELIF 10x45x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0049S 1500-0050S ELIF 10x50x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0059S 1500-0200S ELIF 12x25x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0209S 1500-0210S ELIF 12x30x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0219S 1500-0220S ELIF 12x35x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0229S 1500-0230S ELIF 12x40x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0239S 1500-0240S ELIF 12x45x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0249S 1500-0250S ELIF 12x50x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0259S 1500-0500S ELIF 15x25x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0509S 1500-0510S ELIF 15x30x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0519S 1500-0520S ELIF 15x35x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0529S 1500-0530S ELIF 15x40x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0539S 1500-0540S ELIF 15x45x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0549S 1500-0550S ELIF 15x50x7-16, 0°, STERILE, ELIF INTERBODY, ARIES-E 1500-0559S 1500-1000S ELIF 10x25x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1009S 1500-1010S ELIF 10x30x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1019S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 5

1500-1020S ELIF 10x35x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1029S 1500-1030S ELIF 10x40x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1039S 1500-1040S ELIF 10x45x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1059S 1500-1050S ELIF 10x50x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1059S 1500-1200S ELIF 12x25x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1209S 1500-1210S ELIF 12x30x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1219S 1500-1220S ELIF 12x35x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1229S 1500-1230S ELIF 12x40x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1239S 1500-1240S ELIF 12x45x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1249S 1500- ELIF 12x50x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1259S 1500-1500S ELIF 15x25x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1509S 1500-1510S ELIF 15x30x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1519S 1500-1520S ELIF 15x35x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1529S 1500-1530S ELIF 15x40x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1539S 1500-1540S ELIF 15x45x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1549S 1500-1550S ELIF 15x50x7-16, 7°, STERILE, ELIF INTERBODY, ARIES-E 1500-1559S 1600-0000S OLIF 9x26x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0009S 1600-0010S OLIF 9x28x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0019S 1600-0020S OLIF 9x30x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0029S 1600-0030S OLIF 9x32x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0039S 1600-0040S OLIF 9x34x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0049S 1600-0050S OLIF 9x36x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0059S 1600-0060S OLIF 9x38x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0069S 1600-0100S OLIF 11x26x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0109S 1600-0110S OLIF 11x28x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0119S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 6

1600-0120S OLIF 11x30x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0129S 1600-0130S OLIF 11x32x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0139S 1600-0140S OLIF 11x34x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0149S 1600-0150S OLIF 11x36x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0159S 1600-0160S OLIF 11x38x7-16, 0°, STERILE, OLIF INTERBODY, ARIES-O 1600-0169S 1600-1001S OLIF 9x26x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1009S 1600-1011S OLIF 9x28x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1019S 1600-1021S OLIF 9x30x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1029S 1600-1031S OLIF 9x32x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1039S 1600-1041S OLIF 9x34x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1049S 1600-1051S OLIF 9x36x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1059S 1600-1061S OLIF 9x38x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1069S 1600-1101S OLIF 11x26x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1109S 1600-1111S OLIF 11x28x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1119S 1600-1121S OLIF 11x30x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1129S 1600-1131S OLIF 11x32x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1139S 1600-1141S OLIF 11x34x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1149S 1600-1151S OLIF 11x36x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1159S 1600-1161S OLIF 11x38x8-16, 4°, STERILE, OLIF INTERBODY, ARIES-O 1600-1169S 1600-2002S OLIF 9x26x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2009S 1600-2012S OLIF 9x28x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2019S 1600-2022S OLIF 9x30x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2029S 1600-2032S OLIF 9x32x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2039S 1600-2042S OLIF 9x34x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2049S 1600-2053S OLIF 9x36x10-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2059S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 7

1600-2063S OLIF 9x38x10-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2069S 1600-2102S OLIF 11x26x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2109S 1600-2112S OLIF 11x28x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2119S 1600-2122S OLIF 11x30x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2129S 1600-2132S OLIF 11x32x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2139S 1600-2142S OLIF 11x34x9-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2149S 1600-2153S OLIF 11x36x10-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2159S 1600-2163S OLIF 11x38x10-16, 8°, STERILE, OLIF INTERBODY, ARIES-O 1600-2169S 1600-3003S OLIF 9x26x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3009S 1600-3013S OLIF 9x28x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3019S 1600-3023S OLIF 9x30x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3029S 1600-3033S OLIF 9x32x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3039S 1600-3043S OLIF 9x34x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3049S 1600-3054S OLIF 9x36x11-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3059S 1600-3064S OLIF 9x38x11-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3069S 1600-3103S OLIF 11x26x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3109S 1600-3113S OLIF 11x28x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3119S 1600-3123S OLIF 11x30x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3129S 1600-3133S OLIF 11x32x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3139S 1600-3143S OLIF 11x34x10-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3149S 1600-3154S OLIF 11x36x11-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3159S 1600-3164S OLIF 11x38x11-16, 12°, STERILE, OLIF INTERBODY, ARIES-O 1600-3169S 1300-0000S ALIF 20x26x9-21, 0°, STERILE, ALIF INTERBODY, ARIES-A 1300-0006S 1300-0220S ALIF 24x30x9-21, 0°, STERILE, ALIF INTERBODY, ARIES-A 1300-0226S 1300-0340S ALIF 26x34x9-21, 0°, STERILE, ALIF INTERBODY, ARIES-A 1300-0346S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 8

1300-0460S ALIF 28x38x9-21, 0°, STERILE, ALIF INTERBODY, ARIES-A 1300-0466S 1300-0570S ALIF 30x40x9-21, 0°, STERILE, ALIF INTERBODY, ARIES-A 1300-0576S 1300-1000S ALIF 20x26x9-21, 8°, STERILE, ALIF INTERBODY, ARIES-A 1300-1006S 1300-1220S ALIF 24x30x9-21, 8°, STERILE, ALIF INTERBODY, ARIES-A 1300-1226S 1300-1340S ALIF 26x34x9-21, 8°, STERILE, ALIF INTERBODY, ARIES-A 1300-1346S 1300-1460S ALIF 28x38x9-21, 8°, STERILE, ALIF INTERBODY, ARIES-A 1300-1466S 1300-1570S ALIF 30x40x9-21, 8°, STERILE, ALIF INTERBODY, ARIES-A 1300-1576S 1300-2001S ALIF 20x26x11-21, 16°, STERILE, ALIF INTERBODY, ARIES-A 1300-2006S 1300-2221S ALIF 24x30x11-21, 16°, STERILE, ALIF INTERBODY, ARIES-A 1300-2226S 1300-2341S ALIF 26x34x11-21, 16°, STERILE, ALIF INTERBODY, ARIES-A 1300-2346S 1300-2461S ALIF 28x38x11-21, 16°, STERILE, ALIF INTERBODY, ARIES-A 1300-2466S 1300-2571S ALIF 30x40x11-21, 16°, STERILE, ALIF INTERBODY, ARIES-A 1300-2576S 1300-3003S ALIF 20x26x15-21, 24°, STERILE, ALIF INTERBODY, ARIES-A 1300-3006S 1300-3223S ALIF 24x30x15-21, 24°, STERILE, ALIF INTERBODY, ARIES-A 1300-3226S 1300-3343S ALIF 26x34x15-21, 24°, STERILE, ALIF INTERBODY, ARIES-A 1300-3346S 1300-3463S ALIF 28x38x15-21, 24°, STERILE, ALIF INTERBODY, ARIES-A 1300-3466S 1300-3573S ALIF 30x40x15-21, 24°, STERILE, ALIF INTERBODY, ARIES-A 1300-3576S 1300-4005S ALIF 20x26x19-21, 30°, STERILE, ALIF INTERBODY, ARIES-A 1300-4006S 1300-4225S ALIF 24x30x19-21, 30°, STERILE, ALIF INTERBODY, ARIES-A 1300-4226S 1300-4345S ALIF 26x34x19-21, 30°, STERILE, ALIF INTERBODY, ARIES-A 1300-4346S 1300-4465S ALIF 28x38x19-21, 30°, STERILE, ALIF INTERBODY, ARIES-A 1300-4466S 1300-4575S ALIF 30x40x19-21, 30°, STERILE, ALIF INTERBODY, ARIES-A 1300-4576S

1001 Oakwood Blvd • Round Rock, TX 78681 • (512)388-0199 Tele • (512)692-3699 Fax • [email protected]

Aries Lumbar Interbody Page 9

Instruments

FAMILY PART/ASSEMBLY NUMBER PART/ASSEMBLY DESCRIPTION

TSLIF 1150-0120/1150-0129 10x24x7/16, 0° TSLIF TRIAL, ARIES-TS TSLIF 1150-0320/1150-0329 10x28x7/16, 0° TSLIF TRIAL, ARIES-TS TSLIF 1150-0520/1150-0529 10x32x7/16, 0° TSLIF TRIAL, ARIES-TS TSLIF 1150-1120/1150-1129 10x24x7/16, 7° TSLIF TRIAL, ARIES-TS TSLIF 1150-1320/1150-1329 10x28x7/16, 7° TSLIF TRIAL, ARIES-TS TSLIF 1150-1520/1150-1529 10x32x7/16, 7° TSLIF TRIAL, ARIES-TS TSLIF 1150-3000 TSLIF INSERTER, ARIES-TS TSLIF 1150-6000 TSLIF STRAIGHT TAMP, ARIES-TS TSLIF 1150-7006/1150-7018 6"-18", BONE FUNNEL, ARIES TSLIF 1150-7106/1150-7118 6"-18" BONE FUNNEL IMPACTOR, ARIES TSLIF 1150-8007/1150-8016 7-16mm PADDLE SHAVER, ARIES-TS TSLIF 1150-9000 TSLIF GRAFT PACKING BLOCK, ARIES-TS TSLIF 1150-9010 SMALL GRAFT PACKER TSLIF 1150-9020 FOOTPRINT INSPECTION BLOCK, ARIES-TS TSLIF 9000-168 OSSEUS CUSTOM SLAP HAMMER TSLIF 9000-305 OSSEUS CUSTOM T-HANDLE TCLIF 1250-0200/1250-0209 10x27x7/16, 0° TCLIF TRIAL, ARIES-TC TCLIF 1250-0700/1250-0709 10x32x7/16, 0° TCLIF TRIAL, ARIES-TC TCLIF 1250-1200/1250-1209 10x27x7/16, 7° TCLIF TRIAL, ARIES-TC TCLIF 1250-1700/1250-1709 10x32x7/16, 7° TCLIF TRIAL, ARIES-TC TCLIF 1250-3000 TCLIF INSERTER, ARIES-TC TCLIF 1250-6000 TCLIF STRAIGHT TAMP, ARIES-TC TCLIF 1250-6010 TCLIF SHORT ANGLED TAMP, ARIES-TC TCLIF 1250-6020 TCLIF LONG ANGLED TAMP, ARIES-TC TCLIF 1250-8007/1250-8016 7-16mm PADDLE SHAVER, ARIES-TC TCLIF 1250-9000 TCLIF GRAFT PACKING BLOCK, ARIES-TC TCLIF 1250-9010 FOOTPRINT INSPECTION BLOCK, ARIES-TC LLIF 1450-0200/1450-1204 20x60x8/16, 0° LLIF TRIAL, ARIES-L LLIF 1450-2201/1450-2204 20x60x10/16, 16° LLIF TRIAL, ARIES-L LLIF 1450-3202/1450-3204 20x60x12/16, 24° LLIF TRIAL, ARIES-L LLIF 1450-4203/1450-4204 20x60x14/16, 30° LLIF TRIAL, ARIES-L LLIF 1450-5000 LLIF INSERTER, ARIES-L LLIF 1450-6000 LLIF STRAIGHT TAMP, ARIES-L LLIF 1450-7000 LATERAL RASP, ARIES-L LLIF 1450-7111/1450-7135 LATERAL CUP CURETTE, SIZE 2-6, STRAIGHT/ANGLED, ARIES-L LLIF 1450-7200 LATERAL TEARDROP CURETTE, ARIES-L LLIF 1450-7300 LATERAL TRIANGULAR CURETTE, ARIES-L LLIF 1450-7400 LATERAL RING CURETTE, ARIES-L

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LLIF 1450-7500 LATERAL OSTEOTOME, ARIES_L LLIF 1450-7600/1450-7602 20-30mm LATERAL COBB ELEVATOR, ARIES-L LLIF 1450-7700 KERRISON PUNCH, 40° UP-CUTTING, 4MM TIP, 15 INCH TL LLIF 1450-7701/1450-7703 PITUITARY RONGEUR, STRAIGHT, 4-6MM BITE, 15 INCH TL LLIF 1450-7704 BONE RONGEUR, SLIGHT CURVE, 8MM TIP, 14 INCH TL LLIF 1450-8008/1450-8016 8-16mm PADDLE SHAVER, ARIES-L LLIF 1450-9000 LLIF GRAFT PACKING BLOCK, ARIES-L LLIF 1450-9010 FOOTPRINT INSPECTION BLOCK, ARIES-L OLIF 1605-4000 OLIF INSERTER, ARIES-O ALIF 1350-0220/1350-0226 ALIF TRIAL HEAD, 24x30x9-21, 0°, ARIES-A ALIF 1350-0340/1350-0346 ALIF TRIAL HEAD, 26x34x9-21, 0°, ARIES-A ALIF 1350-0460/1350-0466 ALIF TRIAL HEAD, 28x38x9-21, 0°, ARIES-A ALIF 1350-1220/1350-1226 ALIF TRIAL HEAD, 24x30x9-21, 8°, ARIES-A ALIF 1350-1340/1350-1346 ALIF TRIAL HEAD, 26x34x9-21, 8°, ARIES-A ALIF 1350-1460/1350-1466 ALIF TRIAL HEAD, 28x38x9-21, 8°, ARIES-A ALIF 1350-2221/1350-2226 ALIF TRIAL HEAD, 24x30x11-21, 16°, ARIES-A ALIF 1350-2341/1350-2346 ALIF TRIAL HEAD, 26x34x11-21, 16°, ARIES-A ALIF 1350-2461/1350-2466 ALIF TRIAL HEAD, 28x38x11-21, 16°, ARIES-A ALIF 1350-3223/1350-3226 ALIF TRIAL HEAD, 24x30x15-21, 24°, ARIES-A ALIF 1350-3343/1350-3346 ALIF TRIAL HEAD, 26x34x15-21, 24°, ARIES-A ALIF 1350-3463/1350-3466 ALIF TRIAL HEAD, 28x38x15-21, 24°, ARIES-A ALIF 1350-4225/1350-4226 ALIF TRIAL HEAD, 24x30x19-21, 30°, ARIES-A ALIF 1350-4345/1350-4346 ALIF TRIAL HEAD, 26x34x19-21, 30°, ARIES-A ALIF 1350-4465/1350-4466 ALIF TRIAL HEAD, 28x38x19-21, 30°, ARIES-A ALIF 1350-5000 ALIF INSERTER, ARIES-A ALIF 1350-6000/1350-6010 ALIF STRAIGHT/BAYONETED TAMP, ARIES-A ALIF 1350-8009/1350-8021 9-21mm PADDLE SHAVER, ARIES-A ALIF 1350-9000 ALIF GRAFT PACKING BLOCK, ARIES-A ALIF 1350-9010 LARGE GRAFT PACKER, ARIES ALIF 1350-9030 FOOTPRINT INSPECTION BLOCK, ARIES-A ALIF 1380-9020 DISC WEDGE INSERTER, ARIES-A ALIF 1380-9020-07/1380-9020-17 7-17mm, DISC WEDGE, ARIES-A

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Approved Indications

The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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DESCRIPTION The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. All Aries® Lumbar Interbodies are made from titanium alloy (Ti-6Al-4V) as specified in ASTM F3001.

INDICATIONS The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

WARNINGS One of the potential risks identified with this system is death. Other potential risks which may require additional surgery, include: • device component fracture, • loss of fixation, • non-union, • fracture of the vertebrae, • neurological injury, and • vascular or visceral injury. Certain degenerative diseases or underlying physiological conditions such as diabetes, rheumatoid arthritis, or osteoporosis may alter the healing process, thereby increasing the risk of implant breakage or spinal fracture. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery. Components of this system should not be used with components of any other system or manufacturer. These warnings do not include all adverse effects which could occur with surgery in general but are important considerations particular to orthopedic implants. General surgical risks should be explained to the patient prior to surgery. Use this device as supplied and in accordance with the handling and use information provided below.

PRECAUTIONS The implantation of intervertebral fusion devices should be performed only by experienced spinal surgeons because this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant size. Surgical implants must never be reused. An explanted implant must never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which could lead to breakage. Adequately instruct the patient. Mental or physical impairment which compromises or prevents a patient’s ability to comply with necessary limitations or precautions may place that patient at a particular risk during postoperative rehabilitation. For optimal implant performance, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of the system.

The Aries® Lumbar Interbodies has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in MR environment. The safety of the Aries® Lumbar Interbodies in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Surgical technique manuals are available for detailed instructions on the correct use of the Aries® Lumbar Interbodies.

CONTRAINDICATIONS Use of these implants is contraindicated in patients with the following conditions: 1. Active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. 2. Prior fusion at the level(s) to be treated. 3. Severe osteoporosis which may prevent adequate fixation. 4. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient. 5. Patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure. 6. Any patient not willing to cooperate with postoperative instructions. 7. Any condition not described in the indications for use. 8. Fever or leukocytosis. 9. Pregnancy. 10. Any other condition that would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevations of the white blood count (WBC), or a marked left shift in the WBC differential count. 11. Any case not needing a fusion. 12. Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery. 13. These devices must not be used for pediatric cases or where the patient still has general skeletal growth. 14. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 15. Any case that requires the mixing of metals from two different components or systems. 16. Any patient having inadequate tissue coverage at the operative site or inadequate bone stock or quality. 17. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.

COMPLICATIONS AND POSSIBLE ADVERSE EVENTS Prior to surgery, patients should be made aware of the following possible adverse effects in addition to the potential need for additional surgery to correct these effects: • Loosening, bending or breakage of components • Displacement/migration of device components • Tissue sensitivity to implant material • Potential for skin breakdown and/or wound complications • Non-union or delayed union or mal-union • Infection • Nerve damage, including loss of neurological function (sensory • and/or motor), paralysis, dysesthesia, hyperesthesia, paresthesia, radiculopathy, reflex deficit, cauda equina syndrome • Dural tears, cerebral spinal fluid leakage • Fracture of vertebrae • Foreign body reaction (allergic) to components or debris • Vascular or visceral injury • Change in spinal curvature, loss of correction, height and/or reduction

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• Urinary retention or loss of bladder control • Ileus, gastritis, bowel obstruction • Reproductive system compromise including impotence, sterility, loss of consortium and sexual dysfunction. • Pain or discomfort • Bursitis • Decrease in bone density due to stress shielding • Loss of bone or fracture of bone above or below the level of surgery • Bone graft donor site pain, fracture, and/or delayed wound healing • Restriction of activities • Lack of effective treatment of symptoms for which surgery was intended • Need for additional surgical intervention • Death

PACKAGING These implants and instruments may be supplied pre-packaged and sterile in FDA-cleared packaging, using gamma irradiation. The integrity of the FDA-cleared sterile packaging should be checked to ensure that sterility of the contents is not compromised. FDA-cleared packaging should be carefully checked for completeness and all components should be carefully checked to ensure that there is no damage prior to use. Damaged FDA-cleared packages or products should not be used and should be returned to Osseus Fusion Systems LLC. During surgery, after the correct size has been determined, remove the products from the FDA-cleared packaging using aseptic technique. The instrument sets are provided nonsterile and are steam sterilized prior to use, as described in the STERILIZATION section below. Following use or exposure to soil, instruments must be cleaned, as described in the CLEANING section below.

HANDLING All instruments and implants should be treated with care. Improper use or handling may lead to damage and/or possible malfunction. Products should be checked to ensure that they are in working order prior to surgery. All products should be inspected prior to use to ensure that there is no unacceptable deterioration such as corrosion, discoloration, pitting, cracked seals, etc. Non-working or damaged instruments should not be used and should be returned to Osseus Fusion Systems LLC.

CLEANING All instruments that can be disassembled must be disassembled for cleaning. All handles must be detached. Instruments may be reassembled following sterilization. The instruments should be cleaned using neutral cleaners before sterilization and introduction into a sterile surgical field or (if applicable) return of the product to Osseus Fusion Systems LLC. Cleaning and disinfecting of instruments can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontamination must include the use of neutral cleaners followed by a deionized water rinse. Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used. The following cleaning methods should be observed when cleaning instruments after use or exposure to soil, and prior to sterilization: 1. Immediately following use, ensure that the instruments are wiped down to remove all visible soil and kept from drying by submerging or covering with a wet towel. 2. Disassemble all instruments that can be disassembled. 3. Rinse the instruments under running tap water to remove all visible soil. Flush the lumens a minimum of 3 times, until the lumens flush clean. 4. Prepare Enzol (or a similar enzymatic detergent) per manufacturer’s recommendations. 5. Immerse the instruments in the detergent and allow them to soak for a minimum of 2 minutes. 6. Use a soft bristled brush to thoroughly clean the instruments. Use a pipe cleaner for any lumens. Pay close attention to hard to reach areas. 7. Using a sterile syringe, draw up the enzymatic detergent solution. Flush any lumens and hard to reach areas until no soil is seen exiting the area. 8. Remove the instruments from the detergent and rinse them carefully with warm (30°C to 40°C) tap water a minimum of 30 seconds until no visible soil remains, 9. Visually inspect devices. Repeat pre-cleaning procedure until no visible soil remains. 10. Prepare Enzol® (or a similar enzymatic detergent) per manufacturer’s recommendations in an ultrasonic cleaner. 11. Completely immerse the instruments in the ultrasonic cleaner and ensure detergent is in lumens by flushing the lumens. Sonicate for a minimum of 3 minutes. 12. Remove the instruments from the detergent and rinse them in running deionized water or reverse osmosis water for a minimum of 2 minutes. 13. Dry instruments using a clean soft cloth and filtered pressurized air. 14. Visually inspect each instrument for visible soil. If visible soil is present, then repeat cleaning process starting with Step 3. 15. For difficult to view design features, such as cannulation, apply 3% hydrogen peroxide. Bubbling is indicative of the presence of blood. Note: Rinse the instruments thoroughly with warm water following hydrogen peroxide testing. Repeat cleaning if not visibly clean and re-inspect.

For devices with challenging design features (cannulations, handle interfaces, hinged instruments, instruments with crevices): 1. Immerse instrument and soak for a minimum of five (5) minutes in enzymatic detergent. 2. Use cleaning brushes/pipe cleaners to remove additional soil from challenging design features and areas of high exposure, accumulation, or retention of soil such as: cannulations, handle/ chuck interfaces, hinged instruments, or instruments with crevices. a. Scrub interfaces several times using a twisting action if possible. If components of the instrument can be retracted or moved, it is necessary to retract or open the part in order to access and clean these areas. b. Scrub inside cannulas/holes with a tight-fitting brush or pipe cleaner using a twisting action. The brush or pipe cleaner should be of an appropriate size to ensure that full depth of the feature is reached. c. Scrub around hinged/mating surface areas with a brush or pipe cleaner. d. Scrub all crevices, such as those found around color bands, using a cleaning brush or pipe cleaner. 3. Sonicate instrument in its fully opened position for a minimum of 15 minutes in an ultrasonic cleaner containing warm enzymatic detergent. 4. Rinse thoroughly with warm water, making sure to irrigate the challenging design features. If the components of the instrument are moveable or can be retracted, it is necessary to retract or open the part for thorough rinsing at these locations. Blind holes should be repeatedly filled and emptied. 5. Check instruments for visible soil (see “Verifying Cleaning”). Repeat cleaning if soil is visible.

Verifying cleaning: 1. After thoroughly cleaning, visually inspect devices under normal lighting for the removal of visible soil. 2. For difficult to view design features, apply 3% hydrogen peroxide. Bubbling is indicative of the presence of blood. Note: Rinse the instruments thoroughly with warm water following hydrogen peroxide testing. 3. Repeat cleaning if not visibly clean and re-inspect.

Inspection and function testing:

Device/Feature Flaw All reusable devices Visually inspect for damage or wear. Hinged instruments Check for smooth movement of hinge without excessive “play.” Locking mechanisms Check for action. Cutting features Check edges for distortion/large nicks. Edges should be continuous. Trials Articular surfaces should be smooth and free of cracks and deep nicks. Mating parts Check to make sure that mating parts fit together without complications.

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Device/Feature Flaw Reamer/drill bits Inspect “chuck” end for burrs and distortion that might hinder insertion into a drill. Hammering surfaces Inspect for burrs and large nicks. Driving instruments Inspect plastic ends for cracks and large nicks. Metal surfaces Inspect for corrosion and major deformation.

Maintenance: • For devices with hinged/mating surfaces, surgical-grade lubricant should be added to the hinged area while in the open position. • If the any instruments exhibit any of the flaws listed above adequately dispose of the devices or return to Osseus.

CONTACT INFORMATION Osseus Fusion Systems LLC may be contacted at 1-888-330-5960. A surgical technique manual may be obtained by contacting Osseus Fusion Systems LLC.

STERILIZATION The Aries® Lumbar Interbodies are only available sterile. Sterile implants are sterilized by gamma radiation, validated to ensure a Sterility Assurance Level (SAL) of 10-6. Sterile products are packaged in a FDA-cleared, heat sealed, double foil pouch. The expiration date is provided in the package label. These products are considered sterile unless the FDA-cleared packaging has been opened or damaged. Non- sterile instruments have been validated to ensure an SAL of 10-6. The use of a wrap is recommended, per the Association for the Advancement of Medical Instrumentation (AAMI) ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that are designed for the selected sterilization cycle specifications (time and temperature). When using a rigid sterilization container, the following must be taken into consideration for proper sterilization of Osseus Fusion System LLC’s devices and loaded graphic cases:

Recommended sterilization parameters are listed in the table below. • Only rigid sterilization containers for use with pre-vacuum steam sterilization may be used. • When selecting a rigid sterilization container, it must have a minimum filter area of 176 inch2 total, or a minimum of four (4) 7.5in diameter filters. • No more than one (1) loaded graphic case or its contents can be placed directly into a rigid sterilization container. • Stand-alone modules/racks or single devices must be placed, without stacking, in a container basket to ensure optimal ventilation. • The rigid sterilization container manufacturer’s instructions for use are to be followed; if questions arise, contact the manufacturer of the specific container for guidance. • Refer to AAMI ST79 for additional information concerning the use of rigid sterilization containers.

For instruments provided NONSTERILE, sterilization is recommended (wrapped or containerized) as follows: Method Cycle Type Temperature Exposure Time Drying Time Pre-vacuum 132° C Steam Pre-conditioning pulses: (270° F) 4 minutes 30 minutes 3

These parameters are validated to sterilize only this device. If other products are added to the sterilizer, the recommended parameters are not valid and new cycle parameters must be established by the user. The sterilizer must be properly installed, maintained, and calibrated. Ongoing testing must be performed to confirm inactivation of all forms of viable microorganisms.

SYMBOL GLOSSARY The following table shows symbols and associated descriptions according to ISO 15223 (unless otherwise noted). These symbols may be found throughout Osseus Fusion Systems product labeling.

CAUTION Federal Law restricts this device to sale by or on the order of a Physician.

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