THE ORTHOMEDIX GROUP, INC. MEMORANDUM Date: September 5, 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 1400-1210S LLIF 20x45x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1214S 1400-1220S LLIF 20x50x8-16, 8°, STERILE, LLIF INTERBODY, ARIES-L 1400-1224S 1400-1230S 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 1500-1250S 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