FDA Product Code
FDA Product Code KWS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 191 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K103419 | EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM | Exactech, Inc. | 2010-12-13 | Special | PDF ↗ |
| K093599 | ARROW ANATOMICAL SHOULDER SYSTEM | Fournitures Hospitalieres Industrie | 2010-11-24 | Traditional | PDF ↗ |
| K103104 | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT | Howmedica Osteonics Corp. | 2010-11-22 | Special | PDF ↗ |
| K103007 | AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM | Tornier, Inc. | 2010-11-09 | Special | PDF ↗ |
| K093430 | EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. | Exactech, Inc. | 2010-09-02 | Traditional | PDF ↗ |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | Ascension Orthopedics, Inc. | 2010-08-30 | Traditional | PDF ↗ |
| K091196 | GRS GLENOID RESURFACING SYSTEM | Arthrosurface, Inc. | 2009-10-27 | Traditional | PDF ↗ |
| K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID | DePuy Orthopaedics, Inc. | 2009-07-27 | Special | PDF ↗ |
| K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | DePuy Orthopaedics, Inc. | 2009-07-14 | Special | PDF ↗ |
| K083435 | ARTHREX UNIVERS II SHOULDER PEGGED GLENOID | Arthrex, Inc. | 2009-06-26 | Special | PDF ↗ |
| K082120 | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Tornier | 2008-10-24 | Traditional | PDF ↗ |
| K081707 | AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS | Tornier, Inc. | 2008-07-17 | Special | PDF ↗ |
| K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | DePuy Orthopaedics, Inc. | 2008-06-30 | Special | PDF ↗ |
| K080402 | ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 | Encore Medical L.P. | 2008-03-28 | Traditional | PDF ↗ |
| K071032 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | Arthrex, Inc. | 2007-08-20 | Special | PDF ↗ |
| K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | Zimmer Trabecular Metal Technology | 2007-06-29 | Traditional | PDF ↗ |
| K060694 | MODULAR HYBRID GLENOID | Biomet Manufacturing Corp | 2006-12-11 | Traditional | PDF ↗ |
| K060988 | TOTAL AND HEMI SHOULDER SYSTEM | Dvo Extremity Solutions, LLC | 2006-12-06 | Traditional | PDF ↗ |
| K062029 | ANATOMICAL SHOULDER FRACTURE SYSTEM | Zimmer GmbH | 2006-10-31 | Traditional | PDF ↗ |
| K062113 | SOLAR REUNION FRACTURE STEM | Howmedica Osteonics Corp. | 2006-10-03 | Traditional | PDF ↗ |
| K060874 | DEPUY GLOBAL AP SHOULDER SYSTEM | DePuy Orthopaedics, Inc. | 2006-06-28 | Traditional | PDF ↗ |
| K060209 | AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM | Tornier | 2006-03-02 | Special | PDF ↗ |
| K052472 | DEPUY GLOBAL SHOULDER CROSSLINK GLENOID | DePuy Orthopaedics, Inc. | 2005-10-06 | Special | PDF ↗ |
| K051623 | ANATOMICAL SHOULDER KEELED GLENOID | Zimmer GmbH | 2005-07-19 | Special | PDF ↗ |
| K043346 | GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 | Genesis Medical LLC | 2005-01-31 | Traditional | PDF ↗ |
| K043077 | MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM | Tornier | 2004-12-17 | Traditional | PDF ↗ |
| K043061 | THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX | Zimmer Trabecular | 2004-11-23 | Special | PDF ↗ |
| K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM | Exactech, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K041339 | AEQUALIS SHOULDER SYSTEM | Tornier | 2004-06-17 | Special | PDF ↗ |
| K040610 | VERSA-DIAL HUMERAL HEAD | Biomet Manufacturing, Inc. | 2004-06-04 | Traditional | PDF ↗ |
| K033506 | COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE | Biomet, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K032679 | AEQUALIS SHOULDER FRACTURE SYSTEM | Tornier | 2003-12-15 | Special | PDF ↗ |
| K031449 | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION | Implex Corp. | 2003-09-23 | Traditional | PDF ↗ |
| K030259 | AMATOMICAL SHOULDER WITH REMOVABLE HEAD | Centerplus Orthopedics, Inc. | 2003-04-24 | Traditional | PDF ↗ |
| K030344 | MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS | Smith & Nephew, Inc. | 2003-03-04 | Special | PDF ↗ |
| K020345 | ARTHREX UNIVERS FRACTURE PROSTHESIS | Arthrex, Inc. | 2002-09-06 | Traditional | PDF ↗ |
| K012788 | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II | Smith & Nephew, Inc. | 2002-03-15 | Traditional | PDF ↗ |
| K012378 | 3D HUMERAL HEADS | Smith & Nephew, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K003324 | PLASMA SPRAYED SHOULDER | Encore Orthopedics, Inc. | 2001-12-06 | Traditional | PDF ↗ |
| K012212 | MODIFICATION TO AEQUALIS SHOULDER SYSTEM | Tornier | 2001-08-15 | Special | PDF ↗ |
| K010124 | ARTHREX UNIVERS 30 SHOULDER PROSTHESIS | Arthrex, Inc. | 2001-04-06 | Traditional | PDF ↗ |
| K003801 | ANATOMICAL PRESS-FIT HUMERAL STEM | Sulzer Orthopedics, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K003566 | COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS | Smith & Nephew, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K003832 | SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM | Sulzer Orthopedics, Inc. | 2001-01-04 | Special | PDF ↗ |
| K003728 | MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM | Tornier | 2000-12-20 | Special | PDF ↗ |
| K002683 | WMT ULTRA-FIT MODULAR SHOULDER SYSTEM | Wrightmedicaltechnologyinc | 2000-11-22 | Traditional | PDF ↗ |
| K001706 | WMT MODULAR SHOULDER SYSTEM | Wrightmedicaltechnologyinc | 2000-08-16 | Traditional | PDF ↗ |
| K994393 | AEQUALIS UNIVERSAL SHOULDER GLENOID | Tornier | 2000-06-22 | Traditional | PDF ↗ |
| K001046 | BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS | Biopro, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K994350 | NEER III TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | 2000-05-23 | Traditional | PDF ↗ |
| K994392 | AEQUALIS SHOULDER FRACTURE SYSTEM | Tornier | 2000-03-10 | Traditional | PDF ↗ |
| K000575 | GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD | DePuy Orthopaedics, Inc. | 2000-03-10 | Traditional | PDF ↗ |
| K992899 | BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS | Biomet, Inc. | 1999-10-21 | Traditional | PDF ↗ |
| K992119 | BIO-MODULAR SHOULDER SYSTEM | Biomet, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K980244 | AEQUALIS SHOULDER PROSTHESIS | Tornier | 1999-08-23 | Traditional | PDF ↗ |
| K992065 | GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD | DePuy Orthopaedics, Inc. | 1999-07-12 | Special | PDF ↗ |
| K990598 | OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD | Howmedica Osteonics Corp. | 1999-03-15 | Special | PDF ↗ |
| K990136 | ANATOMICA GLENOID COMPONENT | Sulzer Orthopedics, Inc. | 1999-03-01 | Traditional | PDF ↗ |
| K990137 | ANATOMICA HUMERAL STEM/HEAD COMPONENTS | Sulzer Orthopedics, Inc. | 1999-02-18 | Traditional | PDF ↗ |
| K981487 | DEPUY GLOBAL SHOULDER GLENOID | DePuy Orthopaedics, Inc. | 1998-07-13 | Traditional | PDF ↗ |
| K974044 | GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD | DePuy Orthopaedics, Inc. | 1998-01-22 | Traditional | PDF ↗ |
| K971715 | SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS | Sulzer Orthopedics, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K962224 | SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS | Intermedics Orthopedics | 1996-08-28 | Traditional | PDF ↗ |
| K962082 | OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT | Osteonics Corp. | 1996-08-13 | Traditional | PDF ↗ |
| K960906 | FOUNDATION GLENOID COMPONENT | Encore Orthopedics, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K955944 | OSTEONICS N2/VAC PACKAGING PROCESS | Osteonics Corp. | 1996-04-09 | Traditional | PDF ↗ |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | Smith & Nephew Richards, Inc. | 1996-04-08 | Traditional | PDF ↗ |
| K955731 | OSTEONICS SHOULDER HUMERAL COMPONENTS | Osteonics Corp. | 1996-03-05 | Traditional | PDF ↗ |
| K952928 | AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS | Tornier | 1995-09-27 | Traditional | PDF ↗ |
| K950521 | OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT | Osteonics Corp. | 1995-06-16 | Traditional | PDF ↗ |
| K950651 | TOTAL SHOULDER PROSTHESIS | Encore Orthopedics, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K935802 | SELECT(R) SHOULDER ALL POLY GLENOID | Intermedics Orthopedics | 1995-05-22 | Traditional | PDF ↗ |
| K943300 | DEPUY POROUS COATED GLOBAL SHOULDER | Depuy, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K920362 | 3M MODULAR SHOULDER SYSTEM | 3M Health Care, Ltd. | 1993-07-22 | Traditional | PDF ↗ |
| K904879 | BEUCHEL-PAPPAS GLENOID COMPONENT | Endotec, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K904880 | BUECHEL-PAPPAS HUMERAL STEM COMPONENT | Endotec, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K903886 | OSTEONICS SR GLENOID COMPONENTS | Osteonics Reconstructive Products Div. | 1990-11-20 | Traditional | PDF ↗ |
| K902855 | NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT | Depuy, Inc. | 1990-09-20 | Traditional | PDF ↗ |
| K901434 | PAPILLOTOME | Telemed Systems, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K895226 | NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS | 3M Company | 1989-11-03 | Traditional | PDF ↗ |
| K884943 | INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID | Intermedics Orthopedics | 1989-04-27 | Traditional | PDF ↗ |
| K883816 | SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS | Osteonics Corp. | 1988-11-10 | Traditional | PDF ↗ |
| K881750 | NORMAL HUMERAL PROSTHESIS | Osteonics Corp. | 1988-08-30 | Traditional | PDF ↗ |
| K881836 | INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP | Intermedics Orthopedics | 1988-08-29 | Traditional | PDF ↗ |
| K870262 | FENLIN II SHOULDER PROSTHESIS | Zimmer, Inc. | 1987-04-03 | Traditional | PDF ↗ |
| K862535 | OSTEONICS SHOULDER PROSTHESIS | Osteonics Corp. | 1986-09-02 | Traditional | PDF ↗ |
| K855183 | COFIELD SHOULDER SYSTEM | Richards Medical Co., Inc. | 1986-03-26 | Traditional | PDF ↗ |
| K852365 | LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM | Link America, Inc. | 1985-12-16 | Traditional | PDF ↗ |
| K843624 | COFIELD SHOULDER SYSTEM | Richards Medical Co., Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K833410 | MONOSPHERICAL GLENOID PROSTH. KEEL | Howmedica Corp. | 1983-11-07 | Traditional | PDF ↗ |
| K801970 | UCLA SHOULDER | Howmedica Corp. | 1980-12-31 | Traditional | PDF ↗ |
Product code KWS · Class II · Orthopedic. Data: openFDA.