Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
FDA product code LXT · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
57510(k) clearances
0PMA approvals
13recalls
Implantimplanted device
Manufacturers
- Synthes (Usa) 14
- Howmedica Osteonics Corp. 9
- Hand Innovations, Inc. 6
- Immedica, Inc. 5
- Biomet, Inc. 3
- Encore Orthopedics, Inc. 2
- New Paradigm Biomedical 1
- Howmedica Corp. 1
- Meridian Medical 1
- Dvo Extremity Solutions, LLC 1
- A.M. Surgical, Inc. 1
- Cyberorthology, Inc. 1
- Biomet Orthopedics, Inc. 1
- Ebi, L.P. 1
- Depuy Ace Medical Co. 1
- Orthopaedic Biosystems, Ltd. 1
- Biodynamic Technologies, Inc. 1
- Ace Medical Co. 1
- Smith & Nephew Richards, Inc. 1
- Applied Osteo Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230067 | Para-Fix External Fixation SystemLXT · Traditional | New Paradigm Biomedical | 09/22/2023SE |
| K131636 | Polarus ConnectLXT · Traditional | Acumed, LLC | 10/10/2013SE |
| K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowLXT · Traditional | Biomet | 10/09/2013SE |
| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special | DePuy Orthopaedics, Inc. | 03/11/2009SE |
| K073135 | Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional | Synthes (Usa) | 01/29/2008SE |
| K063832 | Synthes (USA) Elbow Hinge FixatorLXT · Traditional | Synthes (Usa) | 03/07/2007SE |
| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
| K060403 | Pta (Progressive Tibial Alignment)LXT · Traditional | Meridian Medical | 03/28/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
| K052754 | Wrist Fusion PlateLXT · Traditional | Dvo Extremity Solutions, LLC | 10/27/2005SE |
| K051728 | Modification to Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 07/20/2005SE |
| K051306 | Hoffmann II MRI External Fixation SystemLXT · Special | Howmedica Osteonics Corp. | 06/17/2005SE |
| K050932 | Distal Volar Radius Anatomical Plate SystemLXT · Special | Hand Innovations, Inc. | 04/26/2005SE |
| K050631 | Synthes (USA) Small Adjustable Clamp-Mr Safe Line ExtensionLXT · Traditional | Synthes (Usa) | 04/11/2005SE |
| K042458 | A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemLXT · Traditional | A.M. Surgical, Inc. | 10/07/2004SE |
| K042059 | Shoulder Fixation SystemLXT · Traditional | Hand Innovations, Inc. | 09/30/2004SE |
| K033805 | Synthes (USA) 3.5 / 4.5 MM LCP Metaphyseal PlatesLXT · Traditional | Synthes (Usa) | 02/20/2004SE |
| K033145 | Hoffmann II Pelvic ClampLXT · Traditional | Howmedica Osteonics Corp. | 11/05/2003SE |
| K032705 | Distal Radius Fracture Repair SystemLXT · Special | Hand Innovations, Inc. | 10/01/2003SE |
| K032169 | Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)LXT · Traditional | Cyberorthology, Inc. | 09/22/2003SE |
| K031973 | Synthes 4.0 MM Adjustable Clamp for Distal Radius Fixator-Mr SafeLXT · Traditional | Synthes (Usa) | 09/05/2003SE |
| K031428 | Synthes (USA) Large External Fixation Clamps-Mr SafeLXT · Traditional | Synthes (Usa) | 08/08/2003SE |
| K031959 | Stryker Plating System Periarticular PlatesLXT · Special | Howmedica Osteonics Corp. | 07/25/2003SE |
| K030390 | Synthes Large Combination Clamp and Dynamization Clip - MR SafeLXT · Traditional | Synthes (Usa) | 04/01/2003SE |
| K022651 | Hoffmann 30 Degree Pelvic Double Ball JointLXT · Traditional | Howmedica Osteonics Corp. | 10/17/2002SE |
| K020905 | NBX - Non-Bridging External FixatorLXT · Special | Biomet Orthopedics, Inc. | 04/15/2002SE |
| K013739 | Modification to Ebi Xfix DFS SystemLXT · Special | Ebi, L.P. | 12/13/2001SE |
| K013772 | Modification to Hoffmann II Micro External Fixation SystemLXT · Special | Howmedica Osteonics | 12/03/2001SE |
| K011948 | Hoffman II Hybrid Ring ClampLXT · Special | Howmedica Osteonics Corp. | 07/13/2001SE |
| K003240 | Biomet External Wrist PlateLXT · Traditional | Biomet, Inc. | 12/29/2000SE |
| K002923 | Dynamic Joint Distractor II External Fixation SystemLXT · Traditional | Howmedica Osteonics Corp. | 12/18/2000SE |
| K003211 | Hoffmann II Dynamization/Distraction Rod-To-Rod CouplingLXT · Traditional | Howmedica Osteonics Corp. | 12/15/2000SE |
| K003205 | Transfx Angled RodsLXT · Traditional | Immedica, Inc. | 12/15/2000SE |
| K001760 | Radiolucent Colles Fracture KitLXT · Abbreviated | Biomet, Inc. | 08/31/2000SE |
| K001793 | Synthes Scalloped Distal Tibia PlateLXT · Traditional | Synthes (Usa) | 08/17/2000SE |
| K000972 | Synthes (USA) Trochanter Stabilization Plate for DHSLXT · Traditional | Synthes (Usa) | 06/16/2000SE |
| K001084 | Trans FX Adjustable Pin to Bar ClampLXT · Traditional | Immedica, Inc. | 06/15/2000SE |
| K000957 | Hoffmann II External Fixation SystemLXT · Traditional | Howmedica Osteonics Corp. | 05/23/2000SE |
| K000558 | Synthes (USA) Wrist Fusion Plates (WFP)LXT · Traditional | Synthes (Usa) | 04/14/2000SE |
| K991889 | Ultimax Haig II Nail SystemLXT · Traditional | Encore Orthopedics, Inc. | 08/12/1999SE |
| K991723 | Transfx Multi Pin ClampLXT · Traditional | Immedica, Inc. | 07/22/1999SE |
| K991407 | Synthes Locking Calcaneal PlatesLXT · Traditional | Synthes (Usa) | 06/11/1999SE |
| K990848 | Transfx Intermediate External Fixation System,Transfx Small External Fixation System…LXT · Traditional | Immedica, Inc. | 05/17/1999SE |
| K984357 | Transfx External Fixation SystemLXT · Traditional | Immedica, Inc. | 03/04/1999SE |
| K974245 | Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…LXT · Traditional | Depuy Ace Medical Co. | 05/22/1998SE |
| K963432 | Guide Wires for Cannulated ScrewsLXT · Traditional | Orthopaedic Biosystems, Ltd. | 11/13/1996SE |
| K963618 | Synthes Simple Small External Fixator (Ssef)LXT · Traditional | Synthes (Usa) | 11/12/1996SE |
| K962846 | Ez-Fix Compression Hip/Supracondylar Screw (CHS) SystemLXT · Traditional | Biodynamic Technologies, Inc. | 10/23/1996SE |
| K954053 | Berlin External FixatorLXT · Traditional | Encore Orthopedics, Inc. | 05/16/1996SE |
| K960269 | Titanium Universal ClampLXT · Traditional | Synthes (Usa) | 04/04/1996SE |
| K955388 | Ace-Dupont Composite RingsLXT · Traditional | Ace Medical Co. | 01/31/1996SE |
| K953397 | Hex-Fix Field FixatorLXT · Traditional | Smith & Nephew Richards, Inc. | 10/31/1995SE |
| K950384 | Synthes(Usa) Synthes Hybrid External FixatorLXT · Traditional | Synthes (Usa) | 05/22/1995SE |
| K941048 | True/Lok Monolateral/Bilateral FixatorLXT · Traditional | Applied Osteo Systems, Inc. | 10/03/1994SE |
| K874377 | Anatomic Adjustable Axial Fixator AssemblyLXT · Traditional | Harrington Arthritis Research Center | 05/20/1988SE |
| K864403 | Monticelli Spinelli External Fixation SystemLXT · Traditional | Howmedica Corp. | 12/18/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1300-2022 Class II | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the…One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates | Changzhou Biomet Medical Devices Co., Ltd. | 06/02/2022Terminated |
| Z-0709-2019 Class II | Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage:…One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and… | Zimmer Biomet, Inc. | 11/20/2018Terminated |
| Z-0708-2019 Class II | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The…One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and… | Zimmer Biomet, Inc. | 11/20/2018Terminated |
| Z-1082-2016 Class II | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates…Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less… | Biomet, Inc. | 01/29/2016Terminated |
| Z-1446-2015 Class II | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the…A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222… | Biomet, Inc. | 03/18/2015Terminated |
| Z-1538-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1537-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1536-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1535-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1534-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1533-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-1532-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | Zimmer Inc. | 05/01/2009Terminated |
| Z-0674-2008 | Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded…Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors… | Orthofix, Inc | 09/28/2007Terminated |