Extremity Medical, LLC
Parsippany, NJ, US
Extremity Medical, LLC appears in FDA device records in Parsippany, NJ. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Extremity Medical, LLC between 2008 and 2025. The busiest year on record is 2009, with 4. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250536 | MetaFore Small Screw System | HWC | Substantially Equivalent | |
| K251128 | Extremity Medical External Fixation System | KTT | Substantially Equivalent | |
| K241563 | Extremity Medical External Fixation System | KTT | Substantially Equivalent | |
| K212297 | Omni Foot and Ankle Plating System | HRS | Substantially Equivalent | |
| K211261 | Axis Charcot Fixation System | HWC | Substantially Equivalent | |
| K201556 | Intraosseous Fixation System | HWC | Substantially Equivalent | |
| K191525 | KinematX Total Wrist Arthroplasty System | JWJ | Substantially Equivalent | |
| K192592 | Axis Plating System | HRS | Substantially Equivalent | |
| K181067 | AlignX Ankle Fusion System | HRS | Substantially Equivalent | |
| K180808 | Omni Foot Plating System | HRS | Substantially Equivalent | |
| K172260 | Omni Foot Plating System | HRS | Substantially Equivalent | |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | HWC | Substantially Equivalent | |
| K160191 | Align Anterior Ankle Fusion Plate | HRS | Substantially Equivalent | |
| K152710 | HammerFiX Device | HWC | Substantially Equivalent | |
| K150309 | Extremity Medical Calcaneal Osteotomy Device | HWC | Substantially Equivalent | |
| K150166 | Extremity Medical Suture Anchor | MBI | Substantially Equivalent | |
| K143402 | Extremity Medical Calcaneal Osteotomy Device | HWC | Substantially Equivalent | |
| K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE | HWC | Substantially Equivalent | |
| K130120 | EXTREMITY MEDICAL IP FUSION SYSTEM | HWC | Substantially Equivalent | |
| K121417 | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM | HWC | Substantially Equivalent | |
| K121349 | IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER | HWC | Substantially Equivalent | |
| K101700 | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM | HWC | Substantially Equivalent | |
| K093770 | EXTREMITY MEDICAL SCREW SYSTEM | HWC | Substantially Equivalent | |
| K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | KYI | Substantially Equivalent | |
| K091577 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM | HWC | Substantially Equivalent | |
| K082934 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM | HWC | Substantially Equivalent | |
| K083151 | EXTREMITY MEDICAL SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K081934 | EXTREMITY MEDICAL COMPRESSION SCREW | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007289093 | 3007289093 | Extremity Medical, LLC | 300 Interpace Pkwy, Parsippany, NJ 07054 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HTWBit, Drill
- GDJClamp, Surgical, General & Plastic Surgery
- HWWCountersink
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- KYIProsthesis, Wrist, Carpal Trapezium
- KWMProsthesis, Wrist, Semi-Constrained
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0952-2013 | 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. Used in the selection of screw size when used with appropriate depth gauge. | 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. | Class II | Terminated | |
| Z-0752-2013 | 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 gauge over the guidewire and down to the bone. Orthopedic device. | 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). | Class II | Terminated | |
| Z-0438-2013 | 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 most common to orthopedic surgical procedures. | Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. | Class II | Terminated | |
| Z-0344-2013 | 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 fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist. | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain