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 |
|---|---|---|---|
| Nov 5, 2009 | K092440 | ASCENSION CANNULATED SCREW SYSTEM Ascension Orthopedics, Inc. | HWC |
| Nov 5, 2009 | K092133 | ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N Arthrocare Corp. | HWC |
| Oct 2, 2009 | K092082 | SYNERGY CANNULATED SCREW SYSTEM Synergy Surgical Technologies, LLC | HWC |
| Sep 30, 2009 | K091093 | PARCUS PPEK CF INTERFERENCE SCREW Parcus Medical, LLC | HWC |
| Sep 18, 2009 | K092189 | POGO SCREW Fxdevices | HWC |
| Sep 16, 2009 | K091202 | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, Medshape Solutions | HWC |
| Sep 10, 2009 | K090175 | UNITY BETA PLLA SYSTEM Bonutti Research, Inc. | HWC |
| Sep 2, 2009 | K091798 | MERETE COMPRESSION SCREWS Merete Medical GmbH | HWC |
| Jul 31, 2009 | K090949 | SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS Synthes (Usa) | HWC |
| Jul 24, 2009 | K091577 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM Extremity Medical, LLC | HWC |
| Jul 15, 2009 | K083912 | TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS Treu-Instrumente GmbH, DE | HWC |
| Jul 7, 2009 | K091694 | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) Tag Medical Products | HWC |
| Jun 3, 2009 | K090656 | INTERTAN CHS LIMITED COLLAPSE SET SCREW Smith & Nephew, Inc. | HWC |
| Jun 1, 2009 | K091069 | MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT Medacta International S.A. | HWC |
| May 26, 2009 | K081122 | FUSION MEDICAL CANNULATED SCREW SYSTEM John Riccio | HWC |
| May 20, 2009 | K081755 | FUSION MEDICAL STI John Riccio | HWC |
| May 6, 2009 | K090994 | LIGAFIX INTERFACE SCREW Science For Biomaterials, FR | HWC |
| Apr 23, 2009 | K082934 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM Extremity Medical, LLC | HWC |
| Apr 17, 2009 | K083096 | LATARJET CORTICAL SCREW SET Tag Medical Products | HWC |
| Mar 25, 2009 | K083792 | WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 Medshape Solutions | HWC |
| Mar 12, 2009 | K081813 | UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM U.S. Implant Solutions, LLC | HWC |
| Mar 6, 2009 | K083619 | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 Parcus Medical, LLC | HWC |
| Mar 4, 2009 | K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM Cayenne Medical, Inc. | HWC |
| Mar 4, 2009 | K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM Cayenne Medical, Inc. | HWC |
| Feb 5, 2009 | K082874 | BIODRIVE CANNULATED SCREW SYSTEM Biomet Trauma | HWC |
| Dec 8, 2008 | K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc. | HWC |
| Nov 25, 2008 | K082949 | ORTHOPEDIATRICS BONE SCREWS OrthoPediatrics Corp. | HWC |
| Nov 25, 2008 | K080649 | POGO SCREW Fxdevices | HWC |
| Nov 7, 2008 | K082282 | HEALIX TI ANCHOR Depuy Mitek, A Johnson & Johnson Co. | HWC |
| Nov 7, 2008 | K081011 | AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 Arex USA | HWC |
| Nov 5, 2008 | K082320 | DARCO SMALL SCREW Wrightmedicaltechnologyinc | HWC |
| Oct 30, 2008 | K082906 | UNITY BETA ANCHOR SYSTEM Bonutti Research, Inc. | HWC |
| Oct 1, 2008 | K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 Arthrocare Corp. | HWC |
| Sep 17, 2008 | K082516 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS Smith & Nephew, Inc. | HWC |
| Aug 29, 2008 | K081934 | EXTREMITY MEDICAL COMPRESSION SCREW Extremity Medical, LLC | HWC |
| Aug 20, 2008 | K080259 | JMEA CANNULATED BONE SCREW SYSTEM Jmea Corporation | HWC |
| Aug 12, 2008 | K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW Takiron Co., Ltd., JP | HWC |
| Aug 5, 2008 | K081149 | BIOPRO GO-EZ SCREW Biopro, Inc. | HWC |
| Aug 4, 2008 | K081510 | TIGER CANNULATED SCREW SYSTEM Trilliant Surgical, Ltd. | HWC |
| Jul 23, 2008 | K073159 | TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 Trauson (Jiangsu) Medical Instrument Co., Ltd., CN | HWC |
| Jul 18, 2008 | K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS Merete Medical GmbH | HWC |
| Jul 17, 2008 | K081700 | SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION Synthes (Usa) | HWC |
| Jul 14, 2008 | K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR Conmed Linvatec | HWC |
| Jul 10, 2008 | K080778 | ENSPLINT TM BONE SCREW Sonoma Orthopedic Products, Inc. | HWC |
| Jul 1, 2008 | K080974 | TLS FIXATION SYSTEM Fournitures Hospitalieres Industrie, FR | HWC |
| Jun 20, 2008 | K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR Biocomposites, Ltd., GB | HWC |
| Jun 18, 2008 | K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN Bioretec, Ltd., FI | HWC |
| Jun 11, 2008 | K080088 | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS Biomet Manufacturing, Inc. | HWC |
| May 13, 2008 | K073312 | OSTEOTRANS-OT SCREW Takiron Co., Ltd., JP | HWC |
| May 1, 2008 | K081071 | SYNTHES 6.5MM MIDFOOT FUSION BOLT Synthes (Usa) | HWC |
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