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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2006 | DePuy Spine, Inc. Large Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT002 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Small Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT001 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System
Product Code: HT002 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System
Product Code: HT001 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System
Product Number: HT026HI Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System
Product Code: HT025HI Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Large Halo Crown, DePuy Spine Bremer Halo System
Product Number: HT026 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Small Halo Crown, DePuy Spine Bremer Halo System
Product Number: HT025 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. 12 Degree Slider Set, DePuy Spine Bremer Halo System
Product Code: 2923-01-020 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. 0 Degree Slider Set, DePuy Spine Bremer Halo System
Product Code: 2923-01-010 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. DePuy Spine Bremer 3-D Halo Crown System
Product Code: 2923-01-100 Terminated |
HWC | K915800 K993099 |
| Aug 3, 2006 | Zimmer Inc. Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 50 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-50-05 (47115505005). Terminated |
HWC | K792022 |
| Aug 3, 2006 | Zimmer Inc. Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 45 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-45-05 (47115504505). Terminated |
HWC | K792022 |
| Aug 3, 2006 | Zimmer Inc. Zimmer Herbert Cannulated Bone Screw System Bone Screw, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-35-07 (47115503507). Terminated |
HWC | K792022 |
| Aug 3, 2006 | Zimmer Inc. Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 25 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05 (47115502505). Terminated |
HWC | K792022 |
| Aug 3, 2006 | Zimmer Inc. Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 40 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-40 (00662406540). Terminated |
HWC | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535). Terminated |
HWC | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 30 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-30 (00662406530). Terminated |
HWC | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6250-65-20 (00625006520). Terminated |
HWC | K934765 |
| May 18, 2006 | Pioneer Surgical Technology Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN. Terminated |
HWC | K003496 |
| Nov 18, 2005 | Stryker Howmedica Osteonics Corp. Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System) Terminated |
HWC | None listed |
| Nov 18, 2005 | Stryker Howmedica Osteonics Corp. T2 System, Condyle Screw Terminated |
HWC | K010801 |
| Nov 18, 2005 | Stryker Howmedica Osteonics Corp. S2 System, Condyle Screw Terminated |
HWC | K022461 |
| Nov 18, 2005 | Stryker Howmedica Osteonics Corp. S2 System, Locking Screw Fully Threaded Terminated |
HWC | K021026 |
| Nov 18, 2005 | Stryker Howmedica Osteonics Corp. S2 System, Locking Screw Partially Threaded Terminated |
HWC | K021026 |
| Nov 18, 2005 | Stryker Endoscopy Biosteon brand HA/PLLA Cross Pin,
Model Number 234-500-350;
Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 Terminated |
HWC | K021351 |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123. Terminated |
HWC | None listed |
| Jan 15, 2005 | Stryker Endoscopy Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm
Part Numbers: 234-010-078; 234-010-080 Terminated |
HWC | K993166 |
| Feb 27, 2004 | Pioneer Surgical Technology Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001. Terminated |
HWC | K990804 |
| Jun 21, 2003 | Pioneer Surgical Technology StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer Terminated |
HWC | K990804 |
| Apr 1, 2003 | Mitek Worldwide Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head
Product Reference No.: 230420 Terminated |
HWC | K982662 |
| Apr 1, 2003 | Mitek Worldwide Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head
Product Reference No.: 230325 Terminated |
HWC | K982662 |
| Apr 1, 2003 | Mitek Worldwide Mitek M. Kurosaka Advantage 9 X 30 mm Cannulated Fixation Screw
Product Reference No.: 230120 Terminated |
HWC | K933738 |
| Apr 1, 2003 | Mitek Worldwide Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw
Product Reference No.: 230030 Terminated |
HWC | K933738 |
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