510(k) Report

FDA applicant

Orthomet, Inc.

Minneapolis, MN60 decisions1986–19950 recalls

FDA records 60 decisions for Orthomet, Inc. (Minneapolis, MN) from 1986 to 1995: 60 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and JDI (Prosthesis, Hip, Semi-Constrained…). 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 Orthomet, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthomet, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orthomet, Inc.’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?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer19decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented16decisions
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal4decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…2decisions
  • KXAProsthesis, Hip, Femoral, Resurfacing2decisions

Also: HTY (1), HMC (1), HWC (1), HRS (1), LXH (1), KWP (1).

Who builds on its devices?

Later devices cite its devices 17 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.

  • K894334Second Generation Knee SystemOrthomet, Inc. · 19894cite it
  • K931333Orthomet Acetabular Cup SystemOrthomet, Inc. · 19942cite it
  • K926334Axiom Total Knee Syst/Acl Retain Tibial Tray/InserOrthomet, Inc. · 19942cite it
  • K932677Axiom Total Knee SystemOrthomet, Inc. · 19942cite it
  • K912894Axiom Total Knee System, a/P Curved Tibial InsertOrthomet, Inc. · 19911cites it
  • K944752Orthomet Resurfacing Femoral ComponentOrthomet, Inc. · 19941cites it

What has FDA decided for it lately?

  • K936310Orthomet HMC Femoral Stem ComponentOrthomet, Inc. · 1995
  • K945783Orthomet Titanium Hybrid Femoral StemOrthomet, Inc. · 1995
  • K943873Orthomet Anatomically Guided Carpal Tunnel Release SYOrthomet, Inc. · 1995
  • K944752Orthomet Resurfacing Femoral ComponentOrthomet, Inc. · 1994
  • K930771Perfecta Total Hip System Coated Cocr Femoral StemOrthomet, Inc. · 1994
  • K926334Axiom Total Knee Syst/Acl Retain Tibial Tray/InserOrthomet, Inc. · 1994
  • K931333Orthomet Acetabular Cup SystemOrthomet, Inc. · 1994
  • K931678Orthomet LHMC Femoral StemOrthomet, Inc. · 1994

All 60 as Orthomet, Inc. →