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 |
|---|---|---|---|
| Dec 20, 2002 | K023922 | COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 Coapt Systems, Inc. | HWC |
| Dec 9, 2002 | K021233 | AAP CANNULATED SCREWS Aap Implantate AG, DE | HWC |
| Dec 2, 2002 | K022952 | MODULAR HEAD BONE SCREW Biomet, Inc. | HWC |
| Oct 18, 2002 | K023260 | 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM Osteomed Corp. | HWC |
| Oct 17, 2002 | K021351 | BIOSTEON CROSS PIN Biocomposites, Ltd., GB | HWC |
| Oct 9, 2002 | K023294 | BOSWORTH CORACO-CLAVICULAR SCREW Howmedica Osteonics Corp. | HWC |
| Oct 4, 2002 | K023022 | NUGEN FX SCREW Bionx Implants, Inc. | HWC |
| Oct 4, 2002 | K023021 | MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T Smith & Nephew, Inc. | HWC |
| Oct 3, 2002 | K022234 | ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B Arthrex, Inc. | HWC |
| Sep 12, 2002 | K022981 | INION CPS 2.5/2.8 SCREW Inion , Ltd., FI | HWC |
| Sep 6, 2002 | K022726 | STAYFUSE GT-IP Pioneer Surgical Technology | HWC |
| Sep 6, 2002 | K021932 | SYNTHES 6.5 MM CANNULATED SCREW Synthes (Usa) | HWC |
| Sep 5, 2002 | K022647 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM Triad Medical, Inc. | HWC |
| Aug 12, 2002 | K021662 | MAGLY 6.5MM CANNULATED SCREWS Magly Orthopedics, LLC | HWC |
| Aug 9, 2002 | K021579 | MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM Magly Orthopedics, LLC | HWC |
| Aug 9, 2002 | K021556 | SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW Synthes (Usa) | HWC |
| Jul 29, 2002 | K020222 | WISORB MALLEOLAR SCREW Cambridge Scientific, Inc. | HWC |
| Jul 17, 2002 | K021280 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd., FI | HWC |
| Jul 17, 2002 | K021254 | LACTOSORB MINI INTERFERENCE SCREW Biomet Orthopedics, Inc. | HWC |
| Jul 1, 2002 | K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR Mitek Worldwide | HWC |
| Jul 1, 2002 | K021828 | SMALL HAMMER TOE PIN Biomet, Inc. | HWC |
| Jun 26, 2002 | K021832 | ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER Biomet, Inc. | HWC |
| Jun 26, 2002 | K020056 | DUET SUTURE ANCHOR Bionx Implants, Ltd., FI | HWC |
| Jun 25, 2002 | K021030 | TITANIUM CANNULATED INTERFERENCE SCREW Future Medical Systems, Inc. | HWC |
| Jun 11, 2002 | K013131 | BIOSCREW XTRALOK Linvatec Corp. | HWC |
| Jun 6, 2002 | K020791 | HBS HEADLESS BONE SCREW Millennium Medical Technologies, Inc. | HWC |
| May 6, 2002 | K020377 | PRE-LOADED BIOSTINGER HORNET Linvatec Corp. | HWC |
| Apr 2, 2002 | K020043 | 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B Arthrex, Inc. | HWC |
| Mar 27, 2002 | K014304 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S Triage Medical, Inc. | HWC |
| Mar 26, 2002 | K020159 | SMITH & NEPHEW TWINFIX TI QUICK T Smith & Nephew, Inc. | HWC |
| Mar 26, 2002 | K014243 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 Triage Medical, Inc. | HWC |
| Mar 18, 2002 | K014154 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 Vilex, Inc. | HWC |
| Mar 15, 2002 | K014153 | COAPT SYSTMES ENDOTINE DEVICE Coapt Systems, Inc. | HWC |
| Mar 14, 2002 | K013572 | MITEK BIOCRYL INTERFERENCE SCREWS Mitek Products | HWC |
| Mar 13, 2002 | K020446 | MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM American Medical Systems, Inc. | HWC |
| Feb 28, 2002 | K013954 | LORENZ SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Feb 26, 2002 | K020352 | SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE Unitedstates Surgical | HWC |
| Feb 26, 2002 | K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy | HWC |
| Feb 22, 2002 | K020266 | INION CPS BSSO SCREW Inion , Ltd., FI | HWC |
| Feb 13, 2002 | K014185 | AOS CANNULATED BONE SCREW SYSTEM Advanced Orthopaedic Solutions, Inc. | HWC |
| Jan 18, 2002 | K013685 | PLLA CANNULATED INTERFERENCE SCREW Future Medical Systems, Inc. | HWC |
| Dec 17, 2001 | K013903 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 Triad Medical, Inc. | HWC |
| Dec 17, 2001 | K013786 | DRG ORTHOHEX SS BONE SCREW Doctor'S Research Group, Inc. | HWC |
| Dec 17, 2001 | K013534 | SELF-COUNTERSINKING BONE SCREW Biomet Orthopedics, Inc. | HWC |
| Dec 11, 2001 | K013890 | SURGICAL DYNAMICS MENISCAL STAPLE United States Surgical, A Division of Tyco Healthc | HWC |
| Dec 10, 2001 | K011451 | REUNITE FUSION SCREW Biomet, Inc. | HWC |
| Dec 3, 2001 | K013044 | SYNTHES 3.9 MM PELVIC SCREWS Synthes (Usa) | HWC |
| Dec 3, 2001 | K012945 | SYNTHES 2.4 MM CANNULATED SCREW Synthes (Usa) | HWC |
| Dec 3, 2001 | K012572 | SOFT TISSUE SCREW AND WASHER Biomet, Inc. | HWC |
| Dec 3, 2001 | K012469 | RESORBABLE NO PROFILE SCREW AND WASHER Biomet Manufacturing, Inc. | HWC |
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