Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
FDA product code KTW · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
38510(k) clearances
0PMA approvals
56recalls
Implantimplanted device
Manufacturers
- Synthes (Usa) 8
- Advanced Orthopaedic Solutions, Inc. 2
- Howmedica Corp. 2
- Orthofix Srl 2
- Alliance Medical Corp. 2
- Turnkey Intergration USA, Inc. 2
- Buckman Co., Inc. 2
- Mecron Medical Products, Inc. 2
- Warsaw Orthopedic, Inc. 1
- O'Tec Corp. 1
- Applied Osteo Systems, Inc. 1
- Zimmer, Inc. 1
- Onyx Medical Corp. 1
- Trend Medical, Inc. 1
- Wrightmedicaltechnologyinc 1
- Orthospec, Inc. 1
- Biomet, Inc. 1
- Howmedica Osteonics Corp. 1
- Medicalex 1
- Paonan Biotech Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction SystemKTW · Traditional | Paonan Biotech Co., Ltd. | 06/20/2019SE |
| K171606 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. (Aos) | 06/22/2017SE |
| K170693 | Phantom Small Bone Intramedullary Nail SystemKTW · Traditional | Paragon 28, Inc. | 06/19/2017SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. | 03/15/2016SE |
| K122541 | Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special | Orthofix Srl | 09/20/2012SE |
| K080590 | Aos Proximal Humeral PlateKTW · Traditional | Advanced Orthopaedic Solutions, Inc. | 05/06/2008SE |
| K080109 | Synthes (USA) Modular Blade Plate SystemKTW · Traditional | Synthes (Usa) | 03/20/2008SE |
| K062920 | Orthofix Titanium Humeral Plating System LSPKTW · Traditional | Orthofix Srl | 11/13/2006SE |
| K023360 | Leforte System Bone PlateKTW · Traditional | Jeil Medical Corporation | 10/25/2002SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
| K012634 | Reprocessed External Fixation DeviceKTW · Traditional | Alliance Medical, Inc. | 06/24/2002SE |
| K011815 | Synthes LCP Proximal Humerus PlatesKTW · Traditional | Synthes (Usa) | 09/06/2001SE |
| K011458 | Synthes Straight Wrist Fusion Plate, 170MMKTW · Abbreviated | Synthes (Usa) | 08/02/2001SE |
| K010321 | Modular Foot System - 2.7 MM ModuleKTW · Traditional | Synthes (Usa) | 05/02/2001SE |
| K001614 | Stryker Trauma Pelvic SetKTW · Traditional | Howmedica Osteonics Corp. | 08/04/2000SE |
| K001271 | Samarco Spider PlatesKTW · Traditional | Biomet, Inc. | 07/14/2000SE |
| K992837 | 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated Lc-Abp)KTW · Traditional | Synthes (Usa) | 10/25/1999SE |
| K991405 | Omni-Fix, Humeral NailKTW · Traditional | Turnkey Intergration USA, Inc. | 06/29/1999SE |
| K990307 | Omni-Fix, Nail SystemKTW · Traditional | Turnkey Intergration USA, Inc. | 04/01/1999SE |
| K982390 | Concise Compression Hip Screw System (Sterile)KTW · Traditional | Wrightmedicaltechnologyinc | 09/14/1998SE |
| K971272 | Trauma-Fix External FixatorKTW · Traditional | Trend Medical, Inc. | 06/05/1997SE |
| K954289 | Synthes Cannulated Angle Blade PlateKTW · Traditional | Synthes (Usa) | 11/24/1995SE |
| K931686 | Malleolar ScrewKTW · Traditional | Onyx Medical Corp. | 04/05/1994SE |
| K925635 | Torus External Fixation SystemKTW · Traditional | Zimmer, Inc. | 06/01/1993SE |
| K924657 | True/Flex Metatarsal RodsKTW · Traditional | Applied Osteo Systems, Inc. | 11/24/1992SE |
| K914546 | Angled Blade PlateKTW · Traditional | Synthes (Usa) | 11/29/1991SN |
| K905348 | Hansen-Street Type Intramedullary NailKTW · Traditional | O'Tec Corp. | 12/11/1990SE |
| K893928 | Levtech Small Bone PlateKTW · Traditional | Buckman Co., Inc. | 11/03/1989SE |
| K870727 | Warsaw Orthopedic I Bone PlateKTW · Traditional | Warsaw Orthopedic, Inc. | 03/09/1987SE |
| K862552 | Acromed Ads Bone NailKTW · Traditional | Buckman Co., Inc. | 09/02/1986SE |
| K862279 | Expendaguide Multiple Hip Pinning Guide SystemKTW · Traditional | Orthospec, Inc. | 07/25/1986SE |
| K851349 | Lere Nail & Plate Combin. One Piece ForgedKTW · Traditional | Medicalex | 05/29/1985SE |
| K843554 | Bone ScrewsKTW · Traditional | Mecron Medical Products, Inc. | 10/01/1984SE |
| K843553 | Bone PlatesKTW · Traditional | Mecron Medical Products, Inc. | 10/01/1984SE |
| K821566 | Orthopedic Fixation DevicesKTW · Traditional | Howmedica Corp. | 06/03/1982SE |
| K813340 | Hip PinKTW · Traditional | The Deca Co. | 01/29/1982SE |
| K792291 | Synthes Reconstructive Plates 'Y' PlatesKTW · Traditional | Synthes (Usa) | 12/06/1979SE |
| K781762 | Compression Hip Screw SystemKTW · Traditional | Howmedica Corp. | 12/20/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1318-2011 | 02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1317-2011 | 02.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1316-2011 | 02.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1315-2011 | 02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1314-2011 | 02.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1313-2011 | 02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1312-2011 | 02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1311-2011 | 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1310-2011 | 02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1309-2011 | 02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1308-2011 | 02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1307-2011 | 02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1306-2011 | 02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1305-2011 | 02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1304-2011 | 02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1303-2011 | 02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1302-2011 | 02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1301-2011 | 02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1299-2011 | 02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1298-2011 | 02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1297-2011 | 02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1296-2011 | 02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1295-2011 | 02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1294-2011 | 02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1293-2011 | 02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1292-2011 | 02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1291-2011 | 02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1290-2011 | 02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1289-2011 | 02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1288-2011 | 02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1287-2011 | 02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1286-2011 | 02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1285-2011 | 02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1284-2011 | 02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1283-2011 | 02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1282-2011 | 02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1281-2011 | 02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1280-2011 | 02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1279-2011 | 02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1278-2011 | 02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1277-2011 | 02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1276-2011 | 02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1275-2011 | 02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1274-2011 | 02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1273-2011 | 02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1272-2011 | 02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1271-2011 | 02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1270-2011 | 02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1269-2011 | 02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |
| Z-1268-2011 | 02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of…Potential for out of specification star grind teeth. | Synthes USA (HQ), Inc. | 10/27/2010Terminated |