Data / Medical devices / United States / Extremity Medical, LLC
Extremity Medical, LLC: FDA-registered device maker in Parsippany, NJ, United States, 16 510(k) clearances
Extremity Medical, LLC is registered with the FDA (registration 3007289093) in Parsippany, NJ, United States. It lists 24 device types. The FDA files 16 510(k) clearances under its listings, the newest dated October 8, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007289093
- Address
- 300 Interpace Pkwy Building A, 2nd Floor, Parsippany, NJ, United States, 07054
- Owner or operator
- Extremity Medical, LLC (10027988)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 19, 2008
- Registered through
- 2026
- Brand names listed
- 4.5/8.5 Beaming System, APEX, AlignX Ankle Fusion System, ApeX, Axis Charcot Fixation System, Axis Plating System, Bone Graft Harvesting System, CarpalFiX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Wrist, Semi-Constrained | KWM | 2 | Manufacturer for export | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trephine | HWK | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2025 | K250536 | MetaFore Small Screw System | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| May 7, 2025 | K251128 | Extremity Medical External Fixation System | KTT | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| June 10, 2022 | K221362 | Omni Foot and Ankle Plating System | HRS | Substantially Equivalent | Exremity Medical, LLC | accessdata.fda.gov |
| August 20, 2021 | K212297 | Omni Foot and Ankle Plating System | HRS | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| July 8, 2020 | K201556 | Intraosseous Fixation System | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| March 4, 2020 | K191525 | KinematX Total Wrist Arthroplasty System | JWJ | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| November 21, 2019 | K192592 | Axis Plating System | HRS | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| May 23, 2018 | K181067 | AlignX Ankle Fusion System | HRS | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| May 22, 2018 | K180808 | Omni Foot Plating System | HRS | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| July 13, 2017 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| March 4, 2015 | K150309 | Extremity Medical Calcaneal Osteotomy Device | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| December 19, 2014 | K142111 | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE | JDR | Substantially Equivalent | Novatsep | accessdata.fda.gov |
| March 28, 2014 | K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| April 11, 2013 | K130120 | EXTREMITY MEDICAL IP FUSION SYSTEM | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| July 18, 2012 | K121417 | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
| August 29, 2008 | K081934 | EXTREMITY MEDICAL COMPRESSION SCREW | HWC | Substantially Equivalent | Extremity Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 10, 2013 | 64330 | Class II | Terminated | Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Use | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended. | accessdata.fda.gov |
| March 22, 2012 | 63805 | Class II | Terminated | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected). | accessdata.fda.gov |
| April 25, 2011 | 62918 | Class II | Terminated | IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgica | Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. | accessdata.fda.gov |
| April 13, 2011 | 62916 | Class II | Terminated | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service:. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomi | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth
- All makers of Passer, Wire, Orthopedic
- All makers of Bit, Drill
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Template
- All makers of Washer, Bolt Nut
Updated October 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.