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 23, 2008 | K080943 | SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS Synthes (Usa) | HWC |
| Apr 23, 2008 | K080358 | PLLA, HA SCREW Smith & Nephew Inc., Endoscopy Div. | HWC |
| Apr 10, 2008 | K080850 | DARCO HEADLESS COMPRESSION SCREW Wrightmedicaltechnologyinc | HWC |
| Mar 25, 2008 | K080101 | AAP CANNULATED SCREW AND DARCO HEADED SCREW Aap Implantate AG, DE | HWC |
| Mar 14, 2008 | K080280 | SUB-TALAR LOK, MODEL 7-11 MM Instratek, Inc. | HWC |
| Mar 12, 2008 | K080352 | MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE Depuy Mitek, A Johnson & Johnson Company | HWC |
| Mar 4, 2008 | K073509 | TWINFIX PK FP SUTURE ANCHOR Smith & Nephew, Inc. | HWC |
| Feb 19, 2008 | K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM Cayenne Medical, Inc. | HWC |
| Dec 10, 2007 | K072785 | TWINFIX FT PK Smith & Nephew Inc., Endoscopy Division | HWC |
| Dec 4, 2007 | K071941 | MEMOMETAL BONE ANCHORS Memometal Technologies, FR | HWC |
| Nov 27, 2007 | K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER Cayenne Medical, Inc. | HWC |
| Nov 2, 2007 | K072848 | ACTIVASCREW Bioretec, Ltd., FI | HWC |
| Sep 20, 2007 | K071816 | HARPOON SUTURE ANCHOR Biomet Sports Medicine, Inc. | HWC |
| Sep 17, 2007 | K071157 | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS Stryker Endoscopy | HWC |
| Sep 12, 2007 | K071437 | MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C KARL STORZ Endoscopy-America, Inc. | HWC |
| Sep 10, 2007 | K071541 | SBI TWISTOFIX Small Bone Innovations, Inc. | HWC |
| Aug 31, 2007 | K072127 | DOMINATOR Biocomposites, Ltd., GB | HWC |
| Aug 29, 2007 | K063635 | SBI FOREFOOT SET Small Bone Innovations, Inc. | HWC |
| Aug 27, 2007 | K071656 | SBI ARTFIX Small Bone Innovations, Inc. | HWC |
| Aug 14, 2007 | K071952 | GRAFTLOCK SCREW, ST SCREW Biocomposites, Ltd., GB | HWC |
| Aug 13, 2007 | K071035 | IFS BONE FIXATION DEVICES Internal Fixation Systems, Inc. | HWC |
| Aug 9, 2007 | K071481 | HEALIX ANCHOR Depuy Mitek, A Johnson & Johnson Company | HWC |
| Aug 9, 2007 | K070389 | PEEK KNOTLESS ANCHORS Biomet Sports Medicine, Inc. | HWC |
| Aug 3, 2007 | K071464 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion OY, FI | HWC |
| Jul 31, 2007 | K071498 | SUBTALAR IMPLANT Biomet Sports Medicine, Inc. | HWC |
| Jul 9, 2007 | K071639 | QWIX POSITIONING SCREW Newdeal Sas | HWC |
| Jun 29, 2007 | K071177 | ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW Arthrex, Inc. | HWC |
| Jun 14, 2007 | K070617 | CANNULATED SCREW Fournitures Hospitalieres Industrie, FR | HWC |
| May 17, 2007 | K071115 | MODIFICATION TO BILOK ST SCREW Biocomposites, Ltd., GB | HWC |
| May 17, 2007 | K071091 | MODIFICATION TO BILOK SCREW Biocomposites, Ltd., GB | HWC |
| May 11, 2007 | K071092 | ASNIS MICRO CANNULATED SCREW Howmedica Osteonics Corp. | HWC |
| May 11, 2007 | K070347 | ALLOFIX PUSH-IN ANCHOR Musculoskeletal Transplant Foundation | HWC |
| May 9, 2007 | K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 Regeneration Technologies, Inc. | HWC |
| May 8, 2007 | K070441 | METASURG SUBTALAR IMPLANT Metasurg | HWC |
| May 4, 2007 | K070393 | LAGWIRE SYSTEM Fxdevices | HWC |
| May 1, 2007 | K070906 | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS Zimmer, Inc. | HWC |
| Mar 29, 2007 | K070525 | CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER Wrightmedicaltechnologyinc | HWC |
| Mar 29, 2007 | K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW Science For Biomaterials, FR | HWC |
| Mar 21, 2007 | K070039 | MEMOMETAL FIXOS SCREWS Memometal Technologies, FR | HWC |
| Mar 15, 2007 | K062820 | UNITY ALPHA SYSTEM Bonutti Research, Inc. | HWC |
| Mar 2, 2007 | K063588 | MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 Conmed Linvatec Biomaterials, FI | HWC |
| Mar 2, 2007 | K063298 | OSTEOMED HEADLESS CANNULATED SCREW SYSTEM Osteomed LP | HWC |
| Jan 31, 2007 | K063589 | GSO BONE FIXATION FASTENERS Gold Standard Orthopaedics, LLC | HWC |
| Dec 27, 2006 | K063244 | ARC SURGICAL BONE REDUCTION SCREW Arc Surgical, LLC | HWC |
| Dec 15, 2006 | K063478 | VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) Depuy Mitek, A Johnson & Johnson Company | HWC |
| Dec 14, 2006 | K063070 | APERFIX TIBIAL IMPLANT WITH INSERTER Cayenne Medical, Inc. | HWC |
| Dec 13, 2006 | K063479 | ARTHREX PUSHLOCK Arthrex, Inc. | HWC |
| Nov 22, 2006 | K062980 | ACTIVASCREW Bioretec, Ltd., FI | HWC |
| Nov 17, 2006 | K062487 | APERFIX FEMORAL IMPLANT WITH INSERTER Cayenne Medical, Inc. | HWC |
| Oct 31, 2006 | K062863 | OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM Osteomed LP | HWC |
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