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 |
|---|---|---|---|
| Sep 21, 1999 | K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C Bionx Implants, Ltd., FI | HWC |
| Sep 21, 1999 | K992487 | MITEK MINI QUICKANCHOR PLUS Mitek Products | HWC |
| Sep 17, 1999 | K992106 | MODUS SYSTEM SELF-DRILLING SCREWS Medartis AG | HWC |
| Sep 17, 1999 | K990194 | BIOBUTTON Linvatec Corp. | HWC |
| Sep 1, 1999 | K992301 | REUNITE SCREWS Biomet Manufacturing, Inc. | HWC |
| Jul 30, 1999 | K992277 | STAPLETAC BONE ANCHOR SYSTEM Influence, Inc. | HWC |
| Jul 30, 1999 | K990770 | BIORC ANCHOR Linvatec Corp. | HWC |
| Jul 14, 1999 | K991477 | SPIN SNAP-OFF SCREW New Deal, S.A. | HWC |
| Jul 1, 1999 | K990454 | BIO-INTERFERENCE SCREW Innovasive Devices, Inc. | HWC |
| Jun 1, 1999 | K990351 | BONE SCREWS Bregma International Trading Company , Ltd., CA | HWC |
| May 14, 1999 | K991298 | BONE MULCH SCREW SYSTEM Biomet, Inc. | HWC |
| Apr 29, 1999 | K990804 | STAYFUSE Pioneer Surgical Technology | HWC |
| Apr 29, 1999 | K990776 | AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM Aap Implantate AG | HWC |
| Apr 29, 1999 | K990622 | BOLD SCREW New Deal, S.A. | HWC |
| Apr 26, 1999 | K991197 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 Vilex, Inc. | HWC |
| Apr 26, 1999 | K991151 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW Vilex, Inc. | HWC |
| Mar 17, 1999 | K990513 | ULTIMAX CORTICAL BONE SCREWS Biodynamic Technologies, Inc. | HWC |
| Mar 15, 1999 | K990019 | DRG MEDIUM SCREW SYSTEM Dolphin Medical Technologies, Inc. | HWC |
| Feb 3, 1999 | K984209 | STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED Biomet, Inc. | HWC |
| Jan 28, 1999 | K984320 | BIOABSORBABLE INTERFERENCE SCREWS Smith & Nephew, Inc. | HWC |
| Jan 28, 1999 | K983592 | SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS Sulzer Orthopedics, Inc. | HWC |
| Jan 20, 1999 | K984331 | ODI ULTIMATE COMPRESSION HIP SCREW Orthopedic Designs, Inc. | HWC |
| Dec 22, 1998 | K970829 | PHUSIS ABSORBABLE INTERFERENCE SCREW Tornier | HWC |
| Dec 16, 1998 | K983495 | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 Syntec Scientific Corp., TW | HWC |
| Dec 7, 1998 | K983508 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM Osteonics Corp. | HWC |
| Dec 3, 1998 | K983165 | OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| Nov 23, 1998 | K983006 | OSTEO 5.0MM CANNULATED SCREW SYSTEM Stryker Osteonics | HWC |
| Oct 28, 1998 | K982662 | DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DePuy Orthopaedics, Inc. | HWC |
| Oct 16, 1998 | K982497 | ARTHROTEK INTERFERENCE SCREW Biomet, Inc. | HWC |
| Sep 8, 1998 | K980457 | ENDO ABSORBABLE INTERFERENCE SCREW Endo Surgical Concepts, Inc. | HWC |
| Jul 29, 1998 | K982222 | SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM Synthes (Usa) | HWC |
| Jul 1, 1998 | K981187 | ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 Arthrex, Inc. | HWC |
| Jun 25, 1998 | K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM Buckman Co., Inc. | HWC |
| Jun 22, 1998 | K981670 | DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW Depuy, Inc. | HWC |
| May 20, 1998 | K980841 | RCI FIXATION SCREWS Smith & Nephew, Inc. | HWC |
| May 11, 1998 | K981372 | SYNTHES 3.0 MM PC-FIX SYSTEM Synthes (Usa) | HWC |
| May 11, 1998 | K981259 | OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| Apr 29, 1998 | K980681 | INNOVASIVE DEVICES MENISCAL SCREW Innovasive Devices, Inc. | HWC |
| Apr 29, 1998 | K980364 | HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS Howmedica Corp. | HWC |
| Apr 3, 1998 | K980440 | DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW Depuy, Inc. | HWC |
| Mar 27, 1998 | K972919 | BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW Bionx Implants, Inc. | HWC |
| Mar 18, 1998 | K974785 | AUTO-DRIVE BONE SCREW Osteomed Corp. | HWC |
| Mar 12, 1998 | K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS Biodynamic Technologies, Inc. | HWC |
| Mar 3, 1998 | K974538 | MENISCAL REPAIR DEVICE Linvatec Corp. | HWC |
| Feb 27, 1998 | K973758 | BIOSCREW ABSORBABLE INTERFERENCE SREW Linvatec Corp. | HWC |
| Jan 23, 1998 | K972722 | ULTIMATE COMPRESSION SCREW SYSTEM Orthopedic Designs, Inc. | HWC |
| Jan 16, 1998 | K973309 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW Vilex, Inc. | HWC |
| Jan 5, 1998 | K973810 | DRG LARGE SCREW SYSTEM Dolphin Medical Technologies, Inc. | HWC |
| Nov 20, 1997 | K972217 | ORTHOPEDIC SCREW SYSTEM Ferguson Medical | HWC |
| Nov 10, 1997 | K973005 | THE CORIFIX LIGAMENT ANCHOR Corin USA | HWC |
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