Table 3.
FDA PMA-approved peripheral joint prostheses
| Device trade name | PMA number | Device manufacturer | Year of original FDA clearance | Number of PMA supplements cleared | Year of voluntary withdrawal from market | Product lifespan (years) |
|---|---|---|---|---|---|---|
| Ankle prosthesis | ||||||
| Scandinavian Total Ankle Replacement System (STAR™ Ankle) | P050050 | Small Bone Innovations Inc. | 2009 | 7 | NA | NA |
| Finger prosthesis | ||||||
| Braun-Cutter Trapezo-Metacarpal Prosthesis | P960053 | Small Bone Innovations Inc. | 1997 | 5 | NA | NA |
| Ascension® Metacarpal Prosthesis | P000057 | Integral Lifesciences Corp. | 2001 | 8 | NA | NA |
| Hip prosthesis | ||||||
| Osteo Ceramic Hip | P810048 | Smith & Nephew, Inc. | 1982 | 10 | 2007 | 25 |
| DePuy® Hip System | P820024 | DePuy Orthopaedics, Inc. | 1984 | 15 | NA | NA |
| Bias™ Fiber Metal Total Hip System | P850061 | Zimmer, Inc. | 1989 | 2 | NA | NA |
| AML Porocoat® Acetabular Cup Prosthesis | P880025 | DePuy Orthopaedics, Inc. | 1990 | 3 | NA | NA |
| Whiteside EPS™ Femoral Hip Prosthesis | P880076 | Dow Corning Corp. | 1991 | 1 | NA | NA |
| S-ROM Poly-Dial® Constrained Liner | P960054 | DePuy Orthopaedics, Inc. | 1997 | 4 | NA | NA |
| Osteonic Constrained Acetabular Insert | P960047 | Howmedica Osteonics Corp. | 1997 | 4 | NA | NA |
| Keramos™ Ceramic/Ceramic Total Hip System | N980003 | DJO Global, Inc. | 2003 | 2 | NA | NA |
| Ceramic Transcend® Hip Articulation | P010001 | Microport Orthopedics Inc. | 2003 | 6 | NA | NA |
| ABC/Trident® Ceramic-Ceramic Hip Articulation | P000013 | Howmedica Osteonics Corp. | 2003 | 11 | NA | NA |
| Ceramic Transcend® Hip Articulation System | P030027 | Ceramtec GmbH | 2003 | 11 | NA | NA |
| Reflection® Ceramic Acetabuluar System | P030022 | Smith & Nephew, Inc. | 2004 | 31 | NA | NA |
| C2a-Taper™ Acetabular System | P050009 | Biomet, Inc. | 2005 | 7 | NA | NA |
| Duraloc® Option Ceramic Hip System | P040023 | DePuy Othopaedics, Inc. | 2005 | 23 | 2014 | 9 |
| Trilogy® AB Acetabular System | P040048 | Zimmer, Inc. | 2006 | 15 | 2012 | 6 |
| SkelKast Surpass™ Acetabular System | P040051 | StelKast, Inc. | 2006 | 3 | NA | NA |
| Birmingham HipTM Resurfacing (BHR®) System | P040033 | Smith & Nephew, Inc. | 2006 | 26 | 2015 | NA |
| Novation™ Ceramic Articulation Hip System | P050039 | Exactech, Inc. | 2007 | 16 | NA | NA |
| Cormet Hip Resurfacing System | P050016 | Corin Group P.L.C. | 2007 | 11 | NA | NA |
| Conserve® Plus Total Resurfacing Hip System | P030042 | Microport Orthopedics Inc. | 2009 | 4 | 2014 | 5 |
| Ceramax® Ceramic Hip System | P070026 | DePuy Orthopaedics, Inc. | 2010 | 21 | NA | NA |
| Pinnacle® CoMplete® Acetabular Hip System | P090002 | DePuy Orthopaedics, Inc. | 2011 | 9 | 2013 | 2 |
| Knee prosthesis | ||||||
| LCS® Total Knee System | P830055 | DePuy Orthopaedics, Inc. | 1985 | 136 | NA | NA |
| PCA Total Knee System | P840049 | Howmedica Corp. | 1991 | 1 | NA | NA |
| New Jersey LCS® Total Knee System | P910016 | DePuy Orthopaedics, Inc. | 1992 | 14 | 2012 | 20 |
| Natural-Knee® and Natural Knee® II with CSTI | P940002 | Sulzer Medica Ltd. | 1997 | 5 | NA | NA |
| Oxford™ Meniscal Unicompartmental Knee System | P010014 | Biomet, Inc. | 2004 | 42 | NA | NA |
| Nexgen® LPS-Flex Mobile and LPS-Mobile Bearing Knee System | P060037 | Zimmer, Inc. | 2007 | 29 | NA | NA |
| Ligament graft | ||||||
| Gore-Tex Expanded PTFE Prosthetic Ligament | P850074 | W.L. Gore & Associates, Inc. | 1987 | 5 | 2013 | 26 |
| Stryker Knee Augmentation Graft | P850054 | Meadox Medicals Inc. | 1988 | 1 | – | – |
| Kennedy LAD Ligament Augmentation Device | P850069 | 3M Company | 1988 | 11 | 2009 | 21 |
NA = Not applicable.