JDO · Device, Fixation, Proximal Femoral, Implant
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | JDO |
|---|---|
| Device Name | Device, Fixation, Proximal Femoral, Implant |
| 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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | Apr 18, 2023 | SESE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | Smith & Nephew, Inc. | Sep 29, 2022 | SESE |
| K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | Apr 30, 2021 | SESE |
| K193029 | CONQUEST FN | Smith & Nephew, Inc. | Feb 28, 2020 | SESE |
| K173826 | THP Hip Fracture Plating System | Biomet, Inc. | Feb 7, 2018 | SESE |
| K172785 | CONQUEST FN | Smith & Nephew | Dec 22, 2017 | SESE |
| K152686 | CONQUEST FN | Smith & Nephew | Mar 17, 2016 | SESE |
| K140018 | TSP HIP FRACTURE PLATING SYSTEM | Biomet, Inc. | Apr 4, 2014 | SESE |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | Aug 15, 2008 | SESE |
| K080434 | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | Smith & Nephew, Inc. | Apr 10, 2008 | SESE |
| K983814 | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | Efratgo, Ltd. HI Tech Bio-Surgical | Jan 14, 1999 | SESE |
| K981757 | SYNTHES (USA) DHS HELIX SYSTEM | Synthes (Usa) | Jul 17, 1998 | SESE |
| K964259 | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION | Synthes (Usa) | Jan 9, 1997 | SESE |
| K962644 | VIGOR COMPRESSION HIP SCREW SYSTEM | Deutschland Surgical, Inc. | Sep 6, 1996 | SESE |
| K953607 | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) | Synthes (Usa) | Mar 8, 1996 | SESE |
| K951904 | SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] | Synthes (Usa) | Jul 17, 1995 | SESE |
| K934161 | PROFORM HIP SYSTEM | Stelkast Company | Mar 10, 1994 | SESE |
| K934162 | PROFORM HA HIP SYSTEM | Stelkast Company | Mar 9, 1994 | SN |
| K923613 | SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT | Synthes (Usa) | Jun 22, 1993 | SESE |
| K831076 | COMPRESSION SYSTEM | Kirschner Medical Corp. | Apr 28, 1983 | SESE |
Top Applicants
- Synthes (Usa) — 5 clearances
- Biomet, Inc. — 4 clearances
- Smith & Nephew, Inc. — 3 clearances
- Smith & Nephew — 2 clearances
- Stelkast Company — 2 clearances
