510(k) Report

FDA applicant

Internal Fixation Systems, Inc.

Miami, FL4 decisions2006–20110 recalls

FDA records 4 decisions for Internal Fixation Systems, Inc. (Miami, FL) from 2006 to 2011: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 26 predicates, 0 of them its own earlier devices. No recall is 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 Internal Fixation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 12011: 2
2007high 2 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Internal Fixation Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone3decisions
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 26 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 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.

  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 20114cite it
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 20063cite it
  • K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 20072cite it

What has FDA decided for it lately?

  • K113399Ifs Subtalar ImplantInternal Fixation Systems, Inc. · 2011
  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
  • K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006

All 4 as Internal Fixation Systems, Inc. →