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 21, 2001 | K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 Bionx Implants, Inc., FI | HWC |
| Nov 20, 2001 | K012872 | RESORBABLE SCREW ANCHOR Arthrotek, Inc. | HWC |
| Nov 20, 2001 | K012818 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX Triage Medical, Inc. | HWC |
| Nov 20, 2001 | K012817 | HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED Triage Medical, Inc. | HWC |
| Nov 16, 2001 | K012798 | INTEX SCREW Biomet, Inc. | HWC |
| Sep 6, 2001 | K011821 | MODIFICATION TO THE I.C.O.S SCREW New Deal, S.A. | HWC |
| Aug 24, 2001 | K011946 | THE SPIN SNAP-OFF SCREW New Deal, S.A. | HWC |
| Aug 17, 2001 | K012280 | TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 Triage Medical, Inc. | HWC |
| Aug 3, 2001 | K011102 | ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM Aesculap, Inc. | HWC |
| Aug 1, 2001 | K010738 | CANNULATED PLUS SCREW SYSTEM Orthomatrix, Inc. | HWC |
| Jul 18, 2001 | K012001 | SMARTSCREW Bionx Implants, Ltd., FI | HWC |
| Jul 18, 2001 | K012000 | 1.5MM BONE FIXATION KIT Bionx Implants, Ltd., FI | HWC |
| Jul 13, 2001 | K011910 | IN-FAST BONE SCREW SYSTEM American Medical Systems, Inc. | HWC |
| Jul 5, 2001 | K010964 | AUTO-DRIVE LAG SCREW SYSTEM Osteomed Corp. | HWC |
| Jul 2, 2001 | K011719 | PLUS CANCELLOUS BONE SCREWS Plus Orthopedics | HWC |
| Jun 20, 2001 | K010884 | TITANIUM COMPRESSION ANCHOR SYSTEM Anchor Medical Technologies | HWC |
| Jun 15, 2001 | K011262 | MODIFICATION TO THE BOLD SCREW New Deal, S.A. | HWC |
| May 30, 2001 | K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM Osteomed Corp. | HWC |
| May 29, 2001 | K010594 | DJ ORTHOPEDICS POST SCREW Dj Orthopedics, LLC | HWC |
| May 25, 2001 | K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A Bionx Implants, Inc., FI | HWC |
| May 23, 2001 | K010525 | ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM Arthrex, Inc. | HWC |
| May 9, 2001 | K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM Mitek Products | HWC |
| May 8, 2001 | K010595 | DJ ORTHOPEDICS INTERFERENCE SCREW Dj Orthopedics, LLC | HWC |
| Apr 26, 2001 | K003077 | SMARTSCREW MODEL 222006...227510 Bionx Implants, Ltd. | HWC |
| Mar 20, 2001 | K001581 | LACTOSORB 5.0 MM WASHER Biomet, Inc. | HWC |
| Mar 9, 2001 | K003816 | ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM Arthrex, Inc. | HWC |
| Mar 7, 2001 | K002274 | SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW Smith & Nephew, Inc. | HWC |
| Feb 20, 2001 | K003700 | SYNTHES HAMSTRING LOOP Synthes (Usa) | HWC |
| Feb 15, 2001 | K003599 | SMITH & NEPHEW SUTURE ANCHOR Smith & Nephew, Inc. | HWC |
| Feb 8, 2001 | K003641 | BIOLOK SCREW, BIOSTEON SCREW Biocomposites, Ltd., GB | HWC |
| Sep 22, 2000 | K002654 | HOWMEDICA OSTEONICS SHOULDER SCREW Howmedica Osteonics Corp. | HWC |
| Aug 25, 2000 | K002271 | 2.4MM CORTEX SCREW, SELF-TAPPING Synthes (Usa) | HWC |
| Aug 25, 2000 | K002070 | BIOLOK SCREW Biocomposites, Ltd., GB | HWC |
| Aug 4, 2000 | K993166 | STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy | HWC |
| Jul 11, 2000 | K001231 | THE KALIX IMPLANT New Deal, S.A. | HWC |
| Apr 26, 2000 | K993630 | BIOLOK SCREW Encore Orthopedics, Inc. | HWC |
| Apr 3, 2000 | K000080 | ASNIS III CANNULATED SCREW SYSTEM Howmedica Osteonics Corp. | HWC |
| Mar 10, 2000 | K994382 | NONLINEAR TAPER LAG SCREW Theken Surgical | HWC |
| Mar 6, 2000 | K994152 | THE LIGAMENT ANCHOR SOFT SCREW Corin USA | HWC |
| Feb 25, 2000 | K994202 | ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM Smith & Nephew, Inc. | HWC |
| Feb 4, 2000 | K993762 | I.CO.S SCREW New Deal, S.A. | HWC |
| Feb 3, 2000 | K000089 | SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS Synthes (Usa) | HWC |
| Jan 12, 2000 | K992396 | BIORCI SCREW Smith & Nephew Endoscopy, Inc. | HWC |
| Dec 20, 1999 | K993975 | ABSOLUTE ABSORBABLE INTERFERENCE SCREW Innovasive Devices, Inc. | HWC |
| Dec 20, 1999 | K991964 | EIS THREADED SCREW FRACTURE FIXATION Groupe Lepine | HWC |
| Nov 18, 1999 | K992945 | RCI FIXATION SCREWS (WITH ASSORTED SIZES) Smith & Nephew, Inc. | HWC |
| Nov 16, 1999 | K991024 | BONE BULLET SUTURE ANCHOR Linvatec Corp. | HWC |
| Oct 8, 1999 | K993025 | MODIFICATION TO BONE MULCH SCREW SYSTEM Biomet, Inc. | HWC |
| Sep 23, 1999 | K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS Electro-Biology, Inc. | HWC |
| Sep 22, 1999 | K992611 | MITEK ROTATOR CUFF QUICKANCHOR PLUS Mitek Products | HWC |
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