LXT · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | LXT |
|---|---|
| Device Name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
| 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 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | Sep 22, 2023 | SESE |
| K131636 | POLARUS CONNECT | Acumed, LLC | Oct 10, 2013 | SESE |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | Biomet | Oct 9, 2013 | SESE |
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | Medos International SARL | Oct 31, 2011 | SESE |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | DePuy Orthopaedics, Inc. | Mar 11, 2009 | SESE |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | Jan 29, 2008 | SESE |
| K063832 | SYNTHES (USA) ELBOW HINGE FIXATOR | Synthes (Usa) | Mar 7, 2007 | SESE |
| K060864 | MULTIDIRECTIONAL THREADED PEG | Hand Innovations, LLC | Apr 28, 2006 | SESE |
| K060403 | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | Meridian Medical | Mar 28, 2006 | SESE |
| K060290 | SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | Feb 27, 2006 | SESE |
| K052754 | WRIST FUSION PLATE | Dvo Extremity Solutions, LLC | Oct 27, 2005 | SESE |
| K051728 | MODIFICATION TO SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | Jul 20, 2005 | SESE |
| K051306 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | Jun 17, 2005 | SESE |
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | Apr 26, 2005 | SESE |
| K050631 | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | Synthes (Usa) | Apr 11, 2005 | SESE |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | A.M. Surgical, Inc. | Oct 7, 2004 | SESE |
| K042059 | SHOULDER FIXATION SYSTEM | Hand Innovations, Inc. | Sep 30, 2004 | SESE |
| K033805 | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | Synthes (Usa) | Feb 20, 2004 | SESE |
| K033145 | HOFFMANN II PELVIC CLAMP | Howmedica Osteonics Corp. | Nov 5, 2003 | SESE |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | Oct 1, 2003 | SESE |
Top Applicants
- Synthes (Usa) — 14 clearances
- Howmedica Osteonics Corp. — 8 clearances
- Immedica, Inc. — 5 clearances
- Hand Innovations, Inc. — 3 clearances
- Hand Innovations, LLC — 3 clearances
