510(k) Report

FDA applicant

Extremity Medical, LLC

Parsippany, NJ28 decisions2008–20252 recalls

FDA records 28 decisions for Extremity Medical, LLC (Parsippany, NJ) from 2008 to 2025: 28 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 87 predicates, 28 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Extremity Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2008: 12009: 42010: 22012: 22013: 12014: 12015: 42016: 12017: 22018: 22019: 12020: 22021: 22025: 3
2008high 4 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2011: 12012: 1
2008high 1 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Extremity Medical, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Extremity Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone16decisions
  • HRSPlate, Fixation, Bone6decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions
  • JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1decision
  • KYIProsthesis, Wrist, Carpal Trapezium1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 10 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 87 predicates; 28 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 48 times; 28 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 20149cite it
  • K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 20095cite it
  • K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC · 20125cite it
  • K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 20104cite it
  • K081934Extremity Medical Compression ScrewExtremity Medical, LLC · 20084cite it
  • K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 20174cite it

What has FDA decided for it lately?

  • K250536MetaFore Small Screw SystemExtremity Medical, LLC · 2025
  • K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  • K211261Axis Charcot Fixation SystemExtremity Medical, LLC · 2021
  • K201556Intraosseous Fixation SystemExtremity Medical, LLC · 2020
  • K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC · 2020
  • K192592Axis Plating SystemExtremity Medical, LLC · 2019

All 28 as Extremity Medical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K101700Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw…Mar 22, 2012Class II
  • K101700IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com…Apr 13, 2011Class II