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.
Cleared Devices (57)
| 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 |
| K032169 | CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) | Cyberorthology, Inc. | Sep 22, 2003 | SESE |
| K031973 | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE | Synthes (Usa) | Sep 5, 2003 | SESE |
| K031428 | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE | Synthes (Usa) | Aug 8, 2003 | SESE |
| K031959 | STRYKER PLATING SYSTEM PERIARTICULAR PLATES | Howmedica Osteonics Corp. | Jul 25, 2003 | SESE |
| K030390 | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE | Synthes (Usa) | Apr 1, 2003 | SESE |
| K022651 | HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT | Howmedica Osteonics Corp. | Oct 17, 2002 | SESE |
| K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | Biomet Orthopedics, Inc. | Apr 15, 2002 | SESE |
| K013739 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | Dec 13, 2001 | SESE |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics | Dec 3, 2001 | SESE |
| K011948 | HOFFMAN II HYBRID RING CLAMP | Howmedica Osteonics Corp. | Jul 13, 2001 | SESE |
| K003240 | BIOMET EXTERNAL WRIST PLATE | Biomet, Inc. | Dec 29, 2000 | SESE |
| K002923 | DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | Dec 18, 2000 | SESE |
| K003211 | HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING | Howmedica Osteonics Corp. | Dec 15, 2000 | SESE |
| K003205 | TRANSFX ANGLED RODS | Immedica, Inc. | Dec 15, 2000 | SESE |
| K001760 | RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | Aug 31, 2000 | SESE |
| K001793 | SYNTHES SCALLOPED DISTAL TIBIA PLATE | Synthes (Usa) | Aug 17, 2000 | SESE |
| K000972 | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS | Synthes (Usa) | Jun 16, 2000 | SESE |
| K001084 | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | Immedica, Inc. | Jun 15, 2000 | SESE |
| K000957 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | May 23, 2000 | SESE |
| K000558 | SYNTHES (USA) WRIST FUSION PLATES (WFP) | Synthes (Usa) | Apr 14, 2000 | SESE |
| K991889 | ULTIMAX HAIG II NAIL SYSTEM | Encore Orthopedics, Inc. | Aug 12, 1999 | SESE |
| K991723 | TRANSFX MULTI PIN CLAMP | Immedica, Inc. | Jul 22, 1999 | SESE |
| K991407 | SYNTHES LOCKING CALCANEAL PLATES | Synthes (Usa) | Jun 11, 1999 | SESE |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION | Immedica, Inc. | May 17, 1999 | SESE |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM | Immedica, Inc. | Mar 4, 1999 | SESE |
| K974245 | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI | Depuy Ace Medical Co. | May 22, 1998 | SESE |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Orthopaedic Biosystems, Ltd. | Nov 13, 1996 | SESE |
| K963618 | SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) | Synthes (Usa) | Nov 12, 1996 | SESE |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | Biodynamic Technologies, Inc. | Oct 23, 1996 | SESE |
| K954053 | BERLIN EXTERNAL FIXATOR | Encore Orthopedics, Inc. | May 16, 1996 | SESE |
| K960269 | TITANIUM UNIVERSAL CLAMP | Synthes (Usa) | Apr 4, 1996 | SESE |
| K955388 | ACE-DUPONT COMPOSITE RINGS | Ace Medical Co. | Jan 31, 1996 | SESE |
| K953397 | HEX-FIX FIELD FIXATOR | Smith & Nephew Richards, Inc. | Oct 31, 1995 | SESE |
| K950384 | SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR | Synthes (Usa) | May 22, 1995 | SESE |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | Applied Osteo Systems, Inc. | Oct 3, 1994 | SESE |
| K874377 | ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY | Harrington Arthritis Research Center | May 20, 1988 | SESE |
| K864403 | MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM | Howmedica Corp. | Dec 18, 1986 | SESE |
Top Applicants
- Synthes (Usa) — 14 clearances
- Howmedica Osteonics Corp. — 8 clearances
- Immedica, Inc. — 5 clearances
- Hand Innovations, LLC — 3 clearances
- Hand Innovations, Inc. — 3 clearances
