Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2005 | K051098 | PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES Zimmer, Inc. | HWC |
| Jun 17, 2005 | K043176 | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM Arc Surgical, LLC | HWC |
| Jun 9, 2005 | K050767 | STERLING INTERFERENCE SCREW ST Regeneration Technologies, Inc. | HWC |
| May 27, 2005 | K050924 | MERETE DUOTHREADTM BONE SCREW Merete Medical GmbH | HWC |
| May 18, 2005 | K050754 | PRECIMED CANNULATED SCREW SYSTEM Precimed, Inc. | HWC |
| May 12, 2005 | K050749 | ARTHREX TAK FAMILY Arthrex, Inc. | HWC |
| Apr 27, 2005 | K050683 | SYNTHES (USA) 3.5MM CONICAL SCREWS Synthes (Usa) | HWC |
| Apr 21, 2005 | K050636 | SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS Synthes (Usa) | HWC |
| Apr 15, 2005 | K050358 | ARTHERX CORKSCREW FT II SUTURE ANCHOR Arthrex, Inc. | HWC |
| Apr 11, 2005 | K050819 | CHARLOTTE SNAP-OFF SCREW Wrightmedicaltechnologyinc | HWC |
| Mar 25, 2005 | K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET Linvatec Corp. | HWC |
| Mar 21, 2005 | K050634 | MODIFICATION TO: ARTHREX V-TAK Arthrex, Inc. | HWC |
| Mar 17, 2005 | K050346 | STABILIZATION SCREW New Deal, S.A. | HWC |
| Feb 24, 2005 | K043410 | EPIPHYSIS SCREW I.T.S. Implantat-Technologie-Systeme GmbH | HWC |
| Feb 18, 2005 | K043142 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd., FI | HWC |
| Feb 11, 2005 | K050226 | ASIAN INTRAMEDULLARY HIP SCREW NAILS Smith & Nephew, Inc. | HWC |
| Feb 3, 2005 | K043185 | SYNTHES 3.5MM CORTEX SCREWS Synthes (Usa) | HWC |
| Jan 26, 2005 | K043583 | CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 Wrightmedicaltechnologyinc | HWC |
| Jan 21, 2005 | K043102 | MULTI-USE COMPRESSION SCREW Wrightmedicaltechnologyinc | HWC |
| Jan 19, 2005 | K043281 | CHARLOTTE HIGH-DEMAND COMPRESSION SCREW Wrightmedicaltechnologyinc | HWC |
| Dec 20, 2004 | K042079 | OSS/(SCARF)- AND OSW-SCREW O.M.T. Oberflachen-Und Materialtechnologie GmbH | HWC |
| Dec 14, 2004 | K043337 | ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR Arthrex, Inc. | HWC |
| Dec 14, 2004 | K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. | HWC |
| Dec 14, 2004 | K042552 | BIO-CORE INTERFERENCE SCREW Biomet, Inc. | HWC |
| Dec 14, 2004 | K032830 | PLLA CANNULATED INTERFERENCE SCREW Advanced Biomaterials | HWC |
| Nov 9, 2004 | K041075 | FASTIN RC ANCHOR Depuy Mitek, A Johnson & Johnson Company | HWC |
| Nov 9, 2004 | K041069 | SPIRALOK ANCHOR Depuy Mitek, A Johnson & Johnson Company | HWC |
| Nov 5, 2004 | K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE Coapt Systems, Inc. | HWC |
| Nov 4, 2004 | K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE Linvatec Corp. | HWC |
| Nov 4, 2004 | K041356 | ARTHREX TENODESIS SCREW FAMILY Arthrex, Inc. | HWC |
| Nov 4, 2004 | K041189 | ARTHREX TRIMIT FAMILY Arthrex, Inc. | HWC |
| Oct 20, 2004 | K041961 | SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | HWC |
| Oct 7, 2004 | K042356 | SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS Synthes (Usa) | HWC |
| Sep 28, 2004 | K041835 | ENDOTINE MIDFACE B 4.5 DEVICE Coapt Systems, Inc. | HWC |
| Sep 16, 2004 | K042310 | ORTHO-PRO CANNULATED BONE SCREWS Ortho-Pro, LLC | HWC |
| Sep 16, 2004 | K042295 | SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 Linvatec Biomaterials, Ltd., FI | HWC |
| Sep 16, 2004 | K042244 | BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE Triage Medical, Inc. | HWC |
| Sep 16, 2004 | K042030 | HYPROCURE SUBTALAR IMPLANT SYSTEM Graham Medical Technologies, LLC | HWC |
| Sep 8, 2004 | K041936 | BIOPRO SUBTALAR IMPLANT Biopro, Inc. | HWC |
| Sep 8, 2004 | K041749 | SCANDIUS ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | HWC |
| Sep 1, 2004 | K041533 | SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS Synthes (Usa) | HWC |
| Aug 27, 2004 | K042078 | ENDOTINE FOREHEAD TRIPLE DEVICE Coapt Systems, Inc. | HWC |
| Aug 25, 2004 | K041456 | SNAP-OFF SCREWS Fournitures Hospitalieres Industrie, FR | HWC |
| Aug 19, 2004 | K040542 | SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW Smith & Nephew, Inc. | HWC |
| Aug 16, 2004 | K031714 | INION TRINION BIODEGRADABLE MENISCUS SCREW Inion , Ltd., FI | HWC |
| Aug 5, 2004 | K041289 | TALUS OF VILEX (TOV) Vilex, Inc. | HWC |
| Aug 5, 2004 | K041287 | VILEX BONE PLATE SYSTEM Vilex, Inc. | HWC |
| Jul 28, 2004 | K041274 | RESORBABLE INTERFERENCE SCREW Arthrotek, Inc. | HWC |
| Jun 30, 2004 | K033355 | LACTOSCREW SCREW ANCHOR Biomet Orthopedics, Inc. | HWC |
| Jun 24, 2004 | K031939 | BIO-EUROLIG INTERFERENCE SCREW Fournitures Hospitalieres Industrie, FR | HWC |
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