510(k) Report

FDA applicant

Xtremi-T, LLC

Lawrenceville, NJ2 decisions2005–20050 recalls

FDA records 2 decisions for Xtremi-T, LLC (Lawrenceville, NJ) in 2005: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HTY (Pin, Fixation, Smooth). Its devices cite 23 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 Xtremi-T, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xtremi-T, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xtremi-T, LLC 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, Bone1decision
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 23 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 20051cites it

What has FDA decided for it lately?

  • K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 2005

All 2 as Xtremi-T, LLC →