510(k) Report

FDA applicant

Metagen, LLC

Menomonie, WI5 decisions1997–19980 recalls

FDA records 5 decisions for Metagen, LLC (Menomonie, WI) from 1997 to 1998: 5 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and JDQ (Cerclage, Fixation). Its devices cite 13 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 Metagen, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Metagen, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision
  • JDQCerclage, Fixation1decision
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K980609Segmental Defect Replacement SystemMetagen, LLC · 19982cite it
  • K980020Activelock Modular Femoral Hip SystemMetagen, LLC · 19981cites it
  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 19981cites it
  • K963700Metagen High Tibial Osteotomy SystemMetagen, LLC · 19971cites it

What has FDA decided for it lately?

  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
  • K980609Segmental Defect Replacement SystemMetagen, LLC · 1998
  • K980020Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
  • K964003Metagen All Poly Acetabular Cup SystemMetagen, LLC · 1997
  • K963700Metagen High Tibial Osteotomy SystemMetagen, LLC · 1997

All 5 as Metagen, LLC →