KTW · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | KTW |
|---|---|
| Device Name | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (38)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | Jun 20, 2019 | SESE |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | Jun 22, 2017 | SESE |
| K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | Jun 19, 2017 | SESE |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | Mar 15, 2016 | SESE |
| K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | Orthofix Srl | Sep 20, 2012 | SESE |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | May 6, 2008 | SESE |
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | Synthes (Usa) | Mar 20, 2008 | SESE |
| K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | Orthofix Srl | Nov 13, 2006 | SESE |
| K023360 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | Oct 25, 2002 | SESE |
| K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | Jun 24, 2002 | SESE |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical, Inc. | Jun 24, 2002 | SESE |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Synthes (Usa) | Sep 6, 2001 | SESE |
| K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | Synthes (Usa) | Aug 2, 2001 | SESE |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | Synthes (Usa) | May 2, 2001 | SESE |
| K001614 | STRYKER TRAUMA PELVIC SET | Howmedica Osteonics Corp. | Aug 4, 2000 | SESE |
| K001271 | SAMARCO SPIDER PLATES | Biomet, Inc. | Jul 14, 2000 | SESE |
| K992837 | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) | Synthes (Usa) | Oct 25, 1999 | SESE |
| K991405 | OMNI-FIX, HUMERAL NAIL | Turnkey Intergration USA, Inc. | Jun 29, 1999 | SESE |
| K990307 | OMNI-FIX, NAIL SYSTEM | Turnkey Intergration USA, Inc. | Apr 1, 1999 | SESE |
| K982390 | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | Wrightmedicaltechnologyinc | Sep 14, 1998 | SESE |
| K971272 | TRAUMA-FIX EXTERNAL FIXATOR | Trend Medical, Inc. | Jun 5, 1997 | SESE |
| K954289 | SYNTHES CANNULATED ANGLE BLADE PLATE | Synthes (Usa) | Nov 24, 1995 | SESE |
| K931686 | MALLEOLAR SCREW | Onyx Medical Corp. | Apr 5, 1994 | SESE |
| K925635 | TORUS EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | Jun 1, 1993 | SESE |
| K924657 | TRUE/FLEX METATARSAL RODS | Applied Osteo Systems, Inc. | Nov 24, 1992 | SESE |
| K914546 | ANGLED BLADE PLATE | Synthes (Usa) | Nov 29, 1991 | SN |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | O'Tec Corp. | Dec 11, 1990 | SESE |
| K893928 | LEVTECH SMALL BONE PLATE | Buckman Co., Inc. | Nov 3, 1989 | SESE |
| K870727 | WARSAW ORTHOPEDIC I BONE PLATE | Warsaw Orthopedic, Inc. | Mar 9, 1987 | SESE |
| K862552 | ACROMED ADS BONE NAIL | Buckman Co., Inc. | Sep 2, 1986 | SESE |
| K862279 | EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM | Orthospec, Inc. | Jul 25, 1986 | SESE |
| K851349 | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED | Medicalex | May 29, 1985 | SESE |
| K843554 | BONE SCREWS | Mecron Medical Products, Inc. | Oct 1, 1984 | SESE |
| K843553 | BONE PLATES | Mecron Medical Products, Inc. | Oct 1, 1984 | SESE |
| K821566 | ORTHOPEDIC FIXATION DEVICES | Howmedica Corp. | Jun 3, 1982 | SESE |
| K813340 | HIP PIN | The Deca Co. | Jan 29, 1982 | SESE |
| K792291 | SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES | Synthes (Usa) | Dec 6, 1979 | SESE |
| K781762 | COMPRESSION HIP SCREW SYSTEM | Howmedica Corp. | Dec 20, 1978 | SESE |
Top Applicants
- Synthes (Usa) — 8 clearances
- Turnkey Intergration USA, Inc. — 2 clearances
- Orthofix Srl — 2 clearances
- Mecron Medical Products, Inc. — 2 clearances
- Howmedica Corp. — 2 clearances
