Acetabular Wedge Augment System

Orthopaedics

Stryker Hips. Implant with confidence. Restoration® Acetabular Wedge Augment System

Restoration Acetabular Wedge Design Rationale Augments, united with Tritanium, Material Trident, MDM and X3 technologies, is an evolutionary advantage in The Restoration Acetabular Wedge Augments are manufactured from patented Tritanium1 Advanced Total Hip Arthroplasty Fixation Technology. Tritanium is created using commercially pure Titanium (CPTi)—a biologically compatible material. The Titanium matrix, resulting Advanced Fixation in a porous bulk foam structure, closely resembles trabecular bone (Figure 1).2 Versatility Wedge Augment material characteristics include: Average Porosity: 63%3 Simplicity Coefficient of friction: 1.014

Restoration Acetabular Wedge Augments are designed to aid in the reconstruction of minimal to severe bone defects. They provide intraoperative flexibility through optimized screw placement and versatile implant siz- ing and positioning.

Advanced Fixation – Tritanium Porous Technology, optimized screw placement

Versatility – Broad range of implant sizes, adaptable implant geometry and orientation for various defects

Simplicity – Minimal bone removal, simplified trial to implant placement, intuitive and streamlined instrumentation Figure 1: Magnified view of Tritanium matrix

Ancillary Fixation Each Wedge Augment is designed to optimize the number of screw hole options and screw placement to provide enhanced initial stability of the augment.5 Each screw hole allows for a varying degree of angulation, up to 18°, to help achieve purchase with good bone. Either GAP (2080-00XX) or Osteolock (5260-5-0XX) 6.5mm screws can be used to obtain rigid fixation of the Wedge Augment against host bone. Instrumentation Ease of Use The Restoration Wedge Augment instruments, encom- passed in a single tray, are simple and easy to use for trialing and implantation. The system is streamlined to include Wedge Augment Trials and a small number of Final Construct Core Instruments for procedural simplification. The Wedge Augment Trials mimic the geometry of the implants and are color-coded according to OD size. Each trial has the same screw hole configuration as the implant to serve as a visual aid for the location of screws.

Simplified Placement The Restoration Acetabular Augment system was designed with provisions for Kirschner Wires (K-wires) to simplify the placement of the trials and to help the surgeon replicate trial positioning with the implant.

66mm OD 62mm OD 58mm OD

Use of K-wires to place Restoration Acetabular Wedge Augment

54mm OD 50mm OD 46mm OD

Restoration Acetabular Wedge Augment Trials Wedge Features Tritanium bulk foam Range of OD sizes and thickness for spectrum of defects Optimized screw holes K-Wire holes for simplified placement

Product Specifications

The Wedge Augments are offered in 18 differ- Restoration ent sizes consisting of six outer diameter (OD) Acetabular Wedge sizes. The OD sizes range from 46mm to Augment 66mm in 4mm increments. The correspon- ding inner diameter (ID) for each size is 2mm larger than the OD. For each wedge augment, there are three thickness options. See Table 1.

Table 1 Restoration Acetabular Wedge Augment Specifications

Outer Inner No. of Restoration Diameter Diameter Thickness Screw Modular Catalog # (mm) (mm) (mm) Holes Cone Body

5096-4615 46 48 15 3 Optimized 5096-4620 46 48 20 4 screw hole placement 5096-4625 46 48 25 4 5096-5015 50 52 15 3 5096-5020 50 52 20 4 5096-5025 50 52 25 4 Tritanium Advanced 5096-5415 54 56 15 4 Fixation Technology 5096-5420 54 56 20 6 K-wire 5096-5425 54 56 25 6 Holes 5096-5815 58 60 15 6 5096-5820 58 60 20 6 5096-5825 58 60 25 6 5096-6215 62 64 15 6 5096-6220 62 64 20 8 5096-6225 62 64 25 8 Restoration Modular 5096-6615 66 68 15 6 Conical 5096-6620 66 68 20 8 Distal Stem Up to 18° of angulation 5096-6625 66 68 25 8

18 Wedge Sizes in 3 Thicknesses Advanced Advanced Bearing Options Femoral Options MDM X3 Restoration Modular The MDM X3 Mobile Bearing Hip System is the latest The Restoration Modular Stem System is designed to addition to Stryker’s comprehensive solution for both allow surgeons to independently achieve the main primary and revision total hip arthroplasty (THA). goals of hip surgery—attain solid fixation and restore MDM X3 is designed to address stability,6 implant hip biomechanics,12 all with a straightforward set of longevity7 and advanced fixation—helping orthopaedic instrumentation. surgeons with a wide breadth of reconstruction chal- Versatility lenges they may face in hip surgeries. System addresses femoral Type 1 through Type 4 Tritanium, Trident and X3 revisions13,14 Tritanium Advanced Fixation Technology, developed Stability from commercially pure Titanium (CPTi)—a biologi- Designed to allow for restoration of proper biome- cally compatible material, is applied to Stryker’s chanics through independent adjustment of leg Multi-Hole shell to aid in revision THA. length, offset and version12 Trident, an evolutionary shell design with over 10 Simplicity years of clinical history, has demonstrated the lowest Simple, straightforward instrumentation to allow for revision rate (2.4%) among cementless cups at five OR efficiency years according to the 2010 National Joint Registry of England and Wales.8 The Restoration Modular Stem System Both the Tritanium and Trident Acetabular Systems feature a patented15 locking mechanism that outper- forms competitive designs in laboratory testing,9 and is designed to minimize backside wear9 and maximize jump distance for increased stability.10 Compatible with X3 Advanced Bearing Technology, Tritanium and Trident provide solutions for the range of hip surgeries.

The Power of X3 The patented16 X3 Advanced Bearing Technology is designed to minimize the risk of wear and con- sequently help prolong the life of the implant.7,11 X3 has demonstrated a 97% reduction in wear compared to conventional polyethylene.11 References 1. US Patent #7,458,991, 7,740,795, 7,674,426. 2. Ricci J. L., Kauffman J., Jaffe W., et al., “Comparison of Osseointegration and Bone Adhesion to Commercially Pure Titanium and Titanium Alloy,” 23rd Ann. Mtg. Society for Biomaterials, 1997. 3. Stryker Test Report RD-10-044 4. Stryker Test Report RD-07-077 5. Stryker Test Report RD-10-050 Joint Replacements 6. Heffernan, C. , Bhimji, S., Macintyre, J., et al. (2011). Development and Validation of a Novel Modular Dual Mobility Hip Bearing. ORS Annual Meeting Poster #1165. 7. Herrera, L., Lee, R., Longaray, J., et al. (2010). Edge Loading Wear due to Inclination Angle for Three Contemporary Trauma, Extremities & Deformities Hip Bearings. 56th Annual ORS Meeting. Poster #2259. 8. The National Joint Registry of England and Wales, Annual Report 2010. Table 3.3. Based on revision rates according to cup brands for primary hip replacement procedures, undertaken between 1st April 2003 and 31st December 2009, Craniomaxillofacial which were linked to a HES/PEDW episode. 9. Litsky, AS, et al., “Micromotion between the Cup and the Liner in Modular Acetabular Prostheses,” 1999 Society for Biomaterials, 25th Annual Meeting Transactions. Spine 10. Nevelos, J., Bhimji, S., Macintyre, J., et al. (2010). Acetabular Bearing Design has a Greater Influence on Jump Distance than Head Size. 56th Annual ORS Meeting: Poster #2028. 11. Stryker Orthopaedics Restoration® ADM X3® 28 mm ID acetabular inserts made of X3® Gas Plasma Sterilized Biologics UHMWPE, show a 97% reduction in volumetric wear rate versus 28 mm ID Restoration® ADM Duration Gamma Radiation Sterilized UHMWPE. Both ADM constructs utilized a 54mm OD shell and the inserts were approximately 9.9 mm thick. Testing was conducted under multi-axial hip joint simulation for 5 million cycles using a 28mm CoCr modular femoral head articulating counterface and calf serum lubricant. Volumetric wear rates were 109.7±6.0 mm3/106 cycles Surgical Products and -1.03 ± 3.8 mm3/106 cycles for Duration and X3 polyethylene insert test samples. Although in-vitro hip wear simulation methods have not been shown to quantitatively predict clinical wear performance, the current model has been able to reproduce correct wear resistance rankings for some materials with documented clinical results. 1-3 Neuro & ENT [1] Wang, A, et. al., Tribology International, Vol. 31, No. 1-3: 17-33, 1998. [2] Essner, A. et. al., 44th Annual Meeting, ORS, New Orleans, Mar. 16-19, 1998: 774. [3] Essner, A. et. al., 47th Annual Meeting, ORS, San Francisco, Feb. 25-28, 2001: 1007. Interventional Spine 12. Goldberg G, Hozack WJ. Modular Stems for Revision of Peri-prosthetic Hip Fractures: Indications and Technique. Seminars in Arthroplasty 2006 17: 15-17. 13. Patel PD, Klika AK, Murray TG, Elsharkawy KA, Krebs VE, Barsoum WK. Influence of Technique With distally fixed Navigation Modular Stems in Revision Total Hip Arthroplasty. Journal of Arthroplasty 2010. 25: 926-931. 14. Holt G, McCaul J, Jones B, Ingram R, Stark A. Outcome After Femoral Revision Using the Restoration Cone / Conical Femoral Revision Stem. OrthoSuperSite. January 2011. Endoscopy 15. US Patent # 6,475,243. 16. US Patents # 7,517,919 , 7,714,036. Communications

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The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: MDM, Osteolock, Restoration, Stryker, Trident, Tritanium, X3. All other trademarks are trademarks of their respective owners or holders.

Literature Number: LRWS-B KAM/GS 8/11 165