510(k) Report

FDA applicant

Mtp Solutions, LLC

Logan, UT4 decisions2014–20140 recalls

FDA records 4 decisions for Mtp Solutions, LLC (Logan, UT) in 2014: 4 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 13 predicates, 1 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 Mtp Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2014

2014: 4
2014high 4 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Mtp Solutions, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions
  • HWCScrew, Fixation, Bone2decisions

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K133235Threaded Peek K-WireMtp Solutions, LLC · 20142cite it
  • K133229Titanium Suture AnchorMtp Solutions, LLC · 20142cite it
  • K133515Peek Fusion ImplantMtp Solutions, LLC · 20142cite it

What has FDA decided for it lately?

  • K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC · 2014
  • K133235Threaded Peek K-WireMtp Solutions, LLC · 2014
  • K133515Peek Fusion ImplantMtp Solutions, LLC · 2014
  • K133229Titanium Suture AnchorMtp Solutions, LLC · 2014

All 4 as Mtp Solutions, LLC →