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 |
|---|---|---|---|
| Jun 15, 2004 | K040701 | SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS Synthes (Usa) | HWC |
| May 28, 2004 | K040265 | LITTLE GRAFTER SCREW Biocomposites, Ltd., GB | HWC |
| May 25, 2004 | K040656 | MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW Smith & Nephew, Inc. | HWC |
| May 21, 2004 | K040475 | MICROMAX SUTURE ANCHOR Biomet, Inc. | HWC |
| May 10, 2004 | K040740 | ENDOTINE TRANSBLEPH DEVICE Coapt Systems, Inc. | HWC |
| May 7, 2004 | K032894 | OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, Linvatec Biomaterials, Inc., FI | HWC |
| Apr 16, 2004 | K032447 | CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED Linvatec Biomaterials, Ltd., FI | HWC |
| Apr 14, 2004 | K040331 | SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS Smith & Nephew, Inc. | HWC |
| Mar 31, 2004 | K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM United States Surgical, A Division of Tyco Healthc | HWC |
| Mar 31, 2004 | K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW Mitek Worldwide | HWC |
| Mar 1, 2004 | K040356 | KOMPRESSOR SCREW SYSTEM Kinetikos Medical, Inc. | HWC |
| Mar 1, 2004 | K033975 | SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS Synthes (Usa) | HWC |
| Mar 1, 2004 | K033792 | BILOK ST SCREW Biocomposites, Ltd., GB | HWC |
| Feb 23, 2004 | K033749 | TITANIUM CANNULATED INTERFERENCE SCREW Advanced Biomaterials, FR | HWC |
| Jan 15, 2004 | K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM Acumed, LLC | HWC |
| Jan 13, 2004 | K032966 | THE ANSWER SCREW SUPPLEMENTATION SYSTEM Simplicity Orthopedic Solutions, LLC | HWC |
| Dec 31, 2003 | K033804 | BIOANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. | HWC |
| Dec 18, 2003 | K033524 | COAPT ENDOTINE CHIN 3.5 DEVICE Coapt Systems, Inc. | HWC |
| Dec 15, 2003 | K033740 | LORENZ STERNAL CLOSURE SYSTEM Walter Lorenz Surgical, Inc. | HWC |
| Dec 15, 2003 | K032902 | SUBTALAR ARTHRORISIS IMPLANT Nexa Orthopedics, Inc. | HWC |
| Nov 13, 2003 | K033252 | MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy | HWC |
| Nov 5, 2003 | K033233 | LACTOSORB TIBIAL L-15 SCREW AND WASHER Biomet, Inc. | HWC |
| Oct 22, 2003 | K032682 | STS SCREW Ortho-Pro, LLC | HWC |
| Oct 15, 2003 | K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH Mitek Worldwide | HWC |
| Oct 8, 2003 | K032770 | ENDOTINE FOREHEAD DEVICE Coapt Systems, Inc. | HWC |
| Oct 7, 2003 | K032098 | ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B Arthrex, Inc. | HWC |
| Oct 1, 2003 | K032072 | LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE Arthrotek, Inc. | HWC |
| Sep 22, 2003 | K031945 | ARTHREX TRIMIT SCREW, MODEL AR-4161B Arthrex, Inc. | HWC |
| Sep 4, 2003 | K031937 | ALANTECH GRAFT FIXATION SCREW Arthrocare Corp. | HWC |
| Aug 22, 2003 | K031155 | OSTEOMED SUBTALAR IMPLANT SYSTEM Osteomed LP | HWC |
| Aug 11, 2003 | K032228 | LORENZ 2.4 SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Aug 8, 2003 | K032224 | BIORCI SCREW Smith & Nephew, Inc. | HWC |
| Aug 8, 2003 | K030302 | HBS HEADLESS BONE SCREW Schoening & Assoc., Inc. | HWC |
| Jul 14, 2003 | K031050 | PCW PERCUTANEOUS COMPRESSION WIRE Millennium Medical Technologies, Inc. | HWC |
| Jul 1, 2003 | K031685 | TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 Smith & Nephew, Inc. | HWC |
| Jun 26, 2003 | K031751 | RAPIDFIRE SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Jun 26, 2003 | K030995 | MINILOK QUICKANCHOR PLUS Mitek Worldwide | HWC |
| Jun 19, 2003 | K030900 | INION OTPS BIODEGRADABLE FIXATON SYSTEM Inion , Ltd., FI | HWC |
| Jun 2, 2003 | K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy | HWC |
| May 30, 2003 | K023887 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd., FI | HWC |
| Apr 24, 2003 | K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 Bionx Implants, Ltd., FI | HWC |
| Apr 18, 2003 | K023365 | LEFORTE SYSTEM BONE SCREW Jeil Medical Corporation | HWC |
| Mar 20, 2003 | K030706 | EBI DYNAFIX COMPRESSION BONE SCREW Ebi, L.P. | HWC |
| Mar 20, 2003 | K030368 | KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW KARL STORZ Endoscopy-America, Inc. | HWC |
| Mar 20, 2003 | K023192 | STRYKER BIOZIP SUTURE ANCHOR Stryker Endoscopy | HWC |
| Mar 13, 2003 | K024115 | MICROFIX QUICKANCHOR PLUS Mitek Worldwide | HWC |
| Feb 26, 2003 | K023013 | STRYKER XCEL ANCHOR SYSTEM Stryker Endoscopy | HWC |
| Feb 6, 2003 | K024233 | KOMPRESSOR SCREW SYSTEM Kinetikos Medical, Inc. | HWC |
| Jan 9, 2003 | K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM Biomet Orthopedics, Inc. | HWC |
| Dec 20, 2002 | K024060 | MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM Howmedica Osteonics Corp. | HWC |
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