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 |
|---|---|---|---|
| Oct 25, 2006 | K062103 | DARCO FORCE TITANIUM COMPRESSION SCREW Darco International, Inc. | HWC |
| Oct 19, 2006 | K062352 | FRS SCREW DePuy Orthopaedics, Inc. | HWC |
| Oct 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY Arthrex, Inc. | HWC |
| Oct 4, 2006 | K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM Inion , Ltd., FI | HWC |
| Sep 27, 2006 | K062679 | ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES Arthrex, Inc. | HWC |
| Sep 25, 2006 | K061949 | DOUBLEPLAY SUTURE ANCHOR Biocomposites, Ltd., GB | HWC |
| Sep 19, 2006 | K061763 | ARC SURGICAL BIOTRAK SCREW Arc Surgical, LLC | HWC |
| Sep 8, 2006 | K062348 | TIMESH SELF DRILLING SCREW Medtronic Neurosurgery | HWC |
| Jul 27, 2006 | K061621 | SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS Synthes (Usa) | HWC |
| Jul 26, 2006 | K061620 | IFS CANNULATED BONE SCREW Internal Fixation Systems, Inc. | HWC |
| Jul 25, 2006 | K061665 | ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT Arthrex, Inc. | HWC |
| Jul 18, 2006 | K061765 | KALIX II IMPLANT New Deal, S.A. | HWC |
| Jul 5, 2006 | K061262 | LIGAFIX INTERFERENCE SCREW Sciences For Bio Materials, FR | HWC |
| Jun 19, 2006 | K061206 | ACUTE BONE SCREW Acute Innovations, LLC | HWC |
| Jun 15, 2006 | K060830 | MILAGRO INTERFERENCE SCREW Depuy Mitek, A Johnson & Johnson Company | HWC |
| Jun 12, 2006 | K060249 | ULTRATINE FOREHEAD Coapt Systems, Inc. | HWC |
| Jun 12, 2006 | K060248 | ULTRATINE TRANSBLEPH Coapt Systems, Inc. | HWC |
| Jun 9, 2006 | K060914 | TRIDENT ANCHOR Johnson & Johnson Company | HWC |
| Jun 6, 2006 | K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR Arthrotek, Inc. | HWC |
| Jun 6, 2006 | K060664 | FASTIN RC ANCHOR Depuy Mitek | HWC |
| May 19, 2006 | K060478 | ARTHREX BIO-COMPRESSION SCREW Arthrex, Inc. | HWC |
| May 4, 2006 | K060271 | SPIRALOK ANCHOR Depuy Mitek, A Johnson & Johnson Company | HWC |
| Apr 26, 2006 | K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS Zimmer, Inc. | HWC |
| Apr 18, 2006 | K060736 | SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS Smith & Nephew, Inc. | HWC |
| Apr 6, 2006 | K060714 | HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR Conmed Linvatec | HWC |
| Apr 3, 2006 | K053543 | ARTHREX ARTHOERESIS IMPLANT Arthrex, Inc. | HWC |
| Mar 13, 2006 | K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd., FI | HWC |
| Mar 7, 2006 | K060428 | CSS CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc. | HWC |
| Feb 23, 2006 | K060253 | STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. Regeneration Technologies, Inc. | HWC |
| Feb 23, 2006 | K053561 | BIO-MINI REVO SUTURE ANCHOR Conmed Linvatec | HWC |
| Feb 23, 2006 | K053344 | BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR Smith & Nephew, Inc. | HWC |
| Jan 26, 2006 | K060071 | NEXA COMPRESSION SCREW Nexa Orthopedics, Inc. | HWC |
| Jan 26, 2006 | K060026 | KOBY SURGICAL INTERNAL FIXATION SYSTEM Koby Surgical | HWC |
| Jan 26, 2006 | K053338 | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS Arthrex, Inc. | HWC |
| Jan 5, 2006 | K053136 | 5TH METATARSAL FRACTURE SCREW Wrightmedicaltechnologyinc | HWC |
| Dec 14, 2005 | K053394 | NEXA BONE SCREW SYSTEM Nexa Orthopedics, Inc. | HWC |
| Dec 7, 2005 | K053093 | KALIX II IMPLANT, MODEL 141 0XX WITH XX New Deal, S.A. | HWC |
| Nov 16, 2005 | K052405 | STERLING INTERFERENC SCREW HT Regeneration Technologies, Inc. | HWC |
| Nov 7, 2005 | K052607 | ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS Arthrex, Inc. | HWC |
| Nov 7, 2005 | K052576 | SBI AUTOFIX Small Bone Innovations, LLC | HWC |
| Nov 4, 2005 | K050407 | LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 Sciences For Bio Materials, FR | HWC |
| Oct 17, 2005 | K052630 | ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) Depuy Mitek, A Johnson & Johnson Company | HWC |
| Sep 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY Arthrex, Inc. | HWC |
| Sep 7, 2005 | K050388 | REFIX INTERNAL FRACTURE FIXATION SCREWS Xtremi-T, LLC | HWC |
| Sep 6, 2005 | K051611 | MBARESORB IMPLANT Kinetikos Medical, Inc. | HWC |
| Aug 31, 2005 | K050468 | TRIABSORB COMPOSITE SCREW Advanced Biomaterials, FR | HWC |
| Aug 25, 2005 | K052080 | MATRYX INTERFERENCE SCREW Linvatec Biomaterials, Inc., FI | HWC |
| Jul 26, 2005 | K051310 | PLC SCREW Smith & Nephew, Inc. | HWC |
| Jul 11, 2005 | K051309 | ROI FUSION RODS & PLATES Reiley Orthopaedics, Inc. | HWC |
| Jul 7, 2005 | K051323 | MERETE TWISTCUT SNAP-OFF BONE SCREW Merete Medical GmbH | HWC |
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