Company ยท US
Extremity Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2025. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 18 |
| HRS | Plate, Fixation, Bone | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| HTO | Reamer | 1 |
| HXI | Passer, Wire, Orthopedic | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2025 | K250536 | MetaFore Small Screw System Extremity Medical, LLC | HWC |
| May 7, 2025 | K251128 | Extremity Medical External Fixation System Extremity Medical, LLC | KTT |
| Feb 21, 2025 | K241563 | Extremity Medical External Fixation System Extremity Medical, LLC | KTT |
| Aug 20, 2021 | K212297 | Omni Foot and Ankle Plating System Extremity Medical, LLC | HRS |
| May 28, 2021 | K211261 | Axis Charcot Fixation System Extremity Medical, LLC | HWC |
| Jul 8, 2020 | K201556 | Intraosseous Fixation System Extremity Medical, LLC | HWC |
| Mar 4, 2020 | K191525 | KinematX Total Wrist Arthroplasty System Extremity Medical, LLC | JWJ |
| Nov 21, 2019 | K192592 | Axis Plating System Extremity Medical, LLC | HRS |
| May 23, 2018 | K181067 | AlignX Ankle Fusion System Extremity Medical, LLC | HRS |
| May 22, 2018 | K180808 | Omni Foot Plating System Extremity Medical, LLC | HRS |
| Nov 6, 2017 | K172260 | Omni Foot Plating System Extremity Medical, LLC | HRS |
| Jul 13, 2017 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System Extremity Medical, LLC | HWC |
| Mar 25, 2016 | K160191 | Align Anterior Ankle Fusion Plate Extremity Medical, LLC | HRS |
| Oct 15, 2015 | K152710 | HammerFiX Device Extremity Medical, LLC | HWC |
| Mar 4, 2015 | K150309 | Extremity Medical Calcaneal Osteotomy Device Extremity Medical, LLC | HWC |
| Feb 23, 2015 | K150166 | Extremity Medical Suture Anchor Extremity Medical, LLC | MBI |
| Feb 4, 2015 | K143402 | Extremity Medical Calcaneal Osteotomy Device Extremity Medical, LLC | HWC |
| Mar 28, 2014 | K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE Extremity Medical, LLC | HWC |
| Apr 11, 2013 | K130120 | EXTREMITY MEDICAL IP FUSION SYSTEM Extremity Medical, LLC | HWC |
| Jul 18, 2012 | K121417 | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC | HWC |
| Jul 18, 2012 | K121349 | IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER Extremity Medical, LLC | HWC |
| Oct 12, 2010 | K101700 | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC | HWC |
| Apr 28, 2010 | K093770 | EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC | HWC |
| Dec 15, 2009 | K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Extremity Medical, LLC | KYI |
| Jul 24, 2009 | K091577 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM Extremity Medical, LLC | HWC |
| Apr 23, 2009 | K082934 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM Extremity Medical, LLC | HWC |
| Jan 22, 2009 | K083151 | EXTREMITY MEDICAL SUTURE ANCHOR Extremity Medical, LLC | MBI |
| Aug 29, 2008 | K081934 | EXTREMITY MEDICAL COMPRESSION SCREW Extremity Medical, LLC | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2013 | Extremity Medical LLC 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, Terminated |
HXI | None listed |
| Jan 30, 2013 | Extremity Medical LLC 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 sc Terminated |
HWC | K101700 K121347 |
| Nov 26, 2012 | Extremity Medical LLC IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079
The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone Terminated |
HTO | None listed |
| Nov 18, 2012 | Extremity Medical LLC IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079.
The Extremity Medical Screw and Washer System is intended for reduction and internal Terminated |
HWC | K101700 |