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 |
|---|---|---|---|
| Apr 29, 2015 | K150188 | SMV Scientific 4.5 mm Bone Screws Summit Medventures | HWC |
| Mar 31, 2015 | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Zimmer, Inc. | HWC |
| Mar 23, 2015 | K142776 | Flow-Screw Flow-Fx, LLC | HWC |
| Mar 4, 2015 | K150309 | Extremity Medical Calcaneal Osteotomy Device Extremity Medical, LLC | HWC |
| Feb 20, 2015 | K141401 | EASY OUT Feet For Life Podiatry Center | HWC |
| Feb 6, 2015 | K143229 | Nexis osteosynthesis compressive screws Novastep, FR | HWC |
| Feb 6, 2015 | K143146 | Nexis osteosynthesis snap-off screws Novastep, FR | HWC |
| Feb 4, 2015 | K143402 | Extremity Medical Calcaneal Osteotomy Device Extremity Medical, LLC | HWC |
| Jan 23, 2015 | K143460 | Cannulated Screw System Wrightmedicaltechnologyinc | HWC |
| Jan 16, 2015 | K143614 | Arthrex Low Profile Screws Arthrex, Inc. | HWC |
| Jan 16, 2015 | K143039 | CrossRoads Screw System Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | HWC |
| Jan 13, 2015 | K143624 | Headless Compression Screw System Skeletal Dynamics, LLC | HWC |
| Jan 13, 2015 | K142057 | INFIX CANNULATED SCREW SYSTEM Infix Medical, LLC | HWC |
| Jan 8, 2015 | K141857 | CrossTie Intraosseous Fixation System Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | HWC |
| Dec 30, 2014 | K143188 | 3.Omm Biomet Cannulated Screw System Biomet Manufacturing Corp | HWC |
| Dec 22, 2014 | K142528 | AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm Agent Medical, LLC | HWC |
| Dec 19, 2014 | K142707 | AIS Odontoid Fracture Fixation System Aesculap Implant System, Inc. | HWC |
| Dec 15, 2014 | K142490 | ProxiFuse Hammer Toe Device Cartiva, Inc. | HWC |
| Nov 20, 2014 | K142585 | PhaLinx Hammertoe System Wrightmedicaltechnologyinc | HWC |
| Nov 18, 2014 | K130019 | J-SCREW COMPRESSION SCREW Competitive Engineering, Inc. | HWC |
| Nov 13, 2014 | K142658 | Biomet Headless Compression and Twist-off Screws Biomet Manufacturing Corp | HWC |
| Oct 3, 2014 | K142534 | HyProCure II Graham Medical Technologies, LLC Dba Gramedica | HWC |
| Oct 3, 2014 | K142442 | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM Zimmer, Inc. | HWC |
| Sep 29, 2014 | K141290 | HELICAL RIDGE PEEK INTERFERENCE SCREW MedShape, Inc. | HWC |
| Sep 12, 2014 | K141949 | CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM Aap Implantate AG, DE | HWC |
| Sep 10, 2014 | K141937 | TRIDENT FUSION IMPLANT Vilex IN Tennessee, Inc. | HWC |
| Jul 30, 2014 | K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT In2bones Sas | HWC |
| Jul 3, 2014 | K140962 | NORMED VARIO SUBTALAR SCREW Normed Nedizin Technik GmbH | HWC |
| Jun 3, 2014 | K140891 | BIOMET CANNULATED SCREW SYSTEM Biomet, Inc. | HWC |
| May 15, 2014 | K140952 | CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW Wrightmedicaltechnologyinc | HWC |
| May 15, 2014 | K140741 | SALVATION BEAMS AND BOLTS SYSTEM Wrightmedicaltechnologyinc | HWC |
| May 15, 2014 | K133662 | SMITH & NEPHEW CANNULATED CAPTURED SCREW Smith & Nephew, Inc. | HWC |
| May 14, 2014 | K140408 | SALVATION OSTEOPENIC SCREW Wrightmedicaltechnologyinc | HWC |
| May 13, 2014 | K140970 | ONE-PIECE PEEK FUSION IMPLANT Mtp Solutions, LLC | HWC |
| May 1, 2014 | K131920 | STABILIZATION SCREW In2bones Sas | HWC |
| Apr 4, 2014 | K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW In2bones Sas, FR | HWC |
| Mar 28, 2014 | K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE Extremity Medical, LLC | HWC |
| Mar 28, 2014 | K133515 | PEEK FUSION IMPLANT Mtp Solutions, LLC | HWC |
| Mar 20, 2014 | K133842 | TYBER MEDICAL TRAUMA SCREW Tyber Medical, LLC | HWC |
| Mar 7, 2014 | K140148 | PRO-TOE HAMMERTOE FIXATION SYSTEM Wrightmedicaltechnologyinc | HWC |
| Mar 7, 2014 | K133713 | CHARLOTTE (TM) SNAP-OFF SCREW Wrightmedicaltechnologyinc | HWC |
| Mar 6, 2014 | K132244 | N-FORCE FIXATION SYSTEM Innovision, Inc. | HWC |
| Feb 28, 2014 | K140283 | OSTEOMED EXTREMIFUSE SYSTEM Osteomed | HWC |
| Feb 28, 2014 | K133451 | FIXOS SCREW SYSTEM Stryker Trauma AG | HWC |
| Jan 22, 2014 | K130613 | CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM Laura Cattabriga | HWC |
| Dec 18, 2013 | K133460 | APTUS CANNULATED COMPRESSION SCREWS Medartis AG | HWC |
| Dec 18, 2013 | K133440 | AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION Stryker Trauma AG | HWC |
| Dec 16, 2013 | K132910 | DEPUY SYNTHES SPINE DENS ACCESS SYSTEM Synthes USA Products, LLC | HWC |
| Dec 13, 2013 | K133035 | NORMED PELLEGRIN CALCANEUS STOP SCREW Normed Medizin-Technik GmbH | HWC |
| Nov 27, 2013 | K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) Pega Medical, Inc., CA | HWC |
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