JDS · Nail, Fixation, Bone
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | JDS |
|---|---|
| Device Name | Nail, Fixation, Bone |
| 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.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | Jun 12, 2025 | SESE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | Sep 20, 2024 | SESE |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | Aug 22, 2024 | SESE |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | Feb 20, 2024 | SESE |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | Jun 14, 2023 | SESE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | Synthes (USA) Products, LLC | Sep 3, 2020 | SESE |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | Jun 10, 2020 | SESE |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | Feb 20, 2020 | SESE |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | Apr 8, 2015 | SESE |
| K123948 | CHINA NAILS AND ACCESSORIES | Smith & Nephew, Inc. | Mar 14, 2013 | SESE |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Synthes (Usa) | Dec 5, 2011 | SESE |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | Jun 9, 2008 | SESE |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | Sep 27, 2007 | SESE |
| K062872 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | Synthes (Usa) | Mar 13, 2007 | SESE |
| K061783 | KNEE FUSION NAIL | Smith & Nephew, Inc. | Aug 10, 2006 | SESE |
| K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | Smith & Nephew, Inc. | Jun 6, 2006 | SESE |
| K051557 | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS | Smith & Nephew, Inc. | Jun 30, 2005 | SESE |
| K050938 | KNEE FUSION NAIL | Smith & Nephew, Inc. | May 4, 2005 | SESE |
| K040762 | SYNTHES (USA) TIBIAL NAIL SYSTEM EX | Synthes (Usa) | Apr 12, 2004 | SESE |
| K040212 | TRIGEN INTERTAN | Smith & Nephew, Inc. | Feb 20, 2004 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 12 clearances
- Synthes (Usa) — 11 clearances
- Howmedica Corp. — 4 clearances
- Biomet, Inc. — 3 clearances
- Disco-O-Tech Medical Technologies, Ltd. — 2 clearances
