Extremity Medical LLC
FDA Regulatory Profile
Extremity Medical LLC appears in FDA public data with 4 recalls, 28 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0952-2013, Class II) was initiated on January 10, 2013. Its most recent 510(k) clearance was granted on October 8, 2025.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 28
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0952-2013 | Class II | Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number | January 10, 2013 |
| Z-0752-2013 | Class II | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring dev | March 22, 2012 |
| Z-0438-2013 | Class II | IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 | April 25, 2011 |
| Z-0344-2013 | Class II | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: | April 13, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250536 | MetaFore Small Screw System | October 8, 2025 |
| K251128 | Extremity Medical External Fixation System | May 7, 2025 |
| K241563 | Extremity Medical External Fixation System | February 21, 2025 |
| K212297 | Omni Foot and Ankle Plating System | August 20, 2021 |
| K211261 | Axis Charcot Fixation System | May 28, 2021 |
| K201556 | Intraosseous Fixation System | July 8, 2020 |
| K191525 | KinematX Total Wrist Arthroplasty System | March 4, 2020 |
| K192592 | Axis Plating System | November 21, 2019 |
| K181067 | AlignX Ankle Fusion System | May 23, 2018 |
| K180808 | Omni Foot Plating System | May 22, 2018 |
| K172260 | Omni Foot Plating System | November 6, 2017 |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | July 13, 2017 |
| K160191 | Align Anterior Ankle Fusion Plate | March 25, 2016 |
| K152710 | HammerFiX Device | October 15, 2015 |
| K150309 | Extremity Medical Calcaneal Osteotomy Device | March 4, 2015 |
| K150166 | Extremity Medical Suture Anchor | February 23, 2015 |
| K143402 | Extremity Medical Calcaneal Osteotomy Device | February 4, 2015 |
| K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE | March 28, 2014 |
| K130120 | EXTREMITY MEDICAL IP FUSION SYSTEM | April 11, 2013 |
| K121417 | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM | July 18, 2012 |