510(k) Report

FDA applicant

Metasurg

Houston, TX5 decisions2007–20130 recalls

FDA records 5 decisions for Metasurg (Houston, TX) from 2007 to 2013: 5 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JDR (Staple, Fixation, Bone). Its devices cite 7 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 Metasurg’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12009: 12011: 22013: 1
2007high 2 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Metasurg 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
  • JDRStaple, Fixation, Bone1decision
  • KWDProsthesis, Toe, Hemi-, Phalangeal1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 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.

  • K111536Metasurg Digifuse ImplantMetasurg · 20116cite it
  • K070441Metasurg Subtalar ImplantMetasurg · 20073cite it
  • K111265Metasurg Subtalar ImplantMetasurg · 20112cite it
  • K123926Metasurg Nitinol Staple ImplantMetasurg · 20131cites it
  • K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 20091cites it

What has FDA decided for it lately?

  • K123926Metasurg Nitinol Staple ImplantMetasurg · 2013
  • K111265Metasurg Subtalar ImplantMetasurg · 2011
  • K111536Metasurg Digifuse ImplantMetasurg · 2011
  • K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009
  • K070441Metasurg Subtalar ImplantMetasurg · 2007

All 5 as Metasurg →