510(k) Report

FDA applicant

Tgm Medical, Inc.

El Dorado Hills, CA6 decisions2011–20150 recalls

FDA records 6 decisions for Tgm Medical, Inc. (El Dorado Hills, CA) from 2011 to 2015: 6 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Its devices cite 29 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tgm Medical”.

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 Tgm Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 22012: 22013: 12015: 1
2011high 2 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Tgm Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision
  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision

Whose devices does it build on?

Its devices cite 29 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 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.

  • K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular…Tgm Medical · 20114cite it
  • K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert /…Tgm Medical, Inc. · 20111cites it
  • K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 20121cites it

What has FDA decided for it lately?

  • K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
  • K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral &…Tgm Medical, Inc. · 2013
  • K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012
  • K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 2012
  • K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert /…Tgm Medical, Inc. · 2011
  • K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular…Tgm Medical · 2011

All 5 as Tgm Medical, Inc. →The one decision as Tgm Medical →