510(k) Report

FDA applicant

Orthopaedic Innovations, Inc.

Minneapolis, MN8 decisions1995–20020 recalls

FDA records 8 decisions for Orthopaedic Innovations, Inc. (Minneapolis, MN) from 1995 to 2002: 8 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and HRS (Plate, Fixation, Bone). Its devices cite 1 predicate, 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 Orthopaedic Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopaedic Innovations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orthopaedic Innovations, Inc. 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?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3decisions
  • HRSPlate, Fixation, Bone1decision
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal1decision
  • LZNCement Obturator1decision
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K983881Cobra External FixatorOrthopaedic Innovations, Inc. · 19981cites it
  • K960014Practifix External Fixation SystemOrthopaedic Innovations, Inc. · 19961cites it
  • K962646Prime Modular Endo HeadOrthopaedic Innovations, Inc. · 19961cites it

What has FDA decided for it lately?

  • K020145Orthopaedic Innovations Renewal Acetabular Cup SystemOrthopaedic Innovations, Inc. · 2002
  • K983881Cobra External FixatorOrthopaedic Innovations, Inc. · 1998
  • K962646Prime Modular Endo HeadOrthopaedic Innovations, Inc. · 1996
  • K960014Practifix External Fixation SystemOrthopaedic Innovations, Inc. · 1996
  • K955620Prime Cemented Calcar Femoral StemsOrthopaedic Innovations, Inc. · 1996
  • K955751Prime Femoral Cement PlugOrthopaedic Innovations, Inc. · 1996
  • K953033Prime Cemented Small Femoral StemOrthopaedic Innovations, Inc. · 1995
  • K940328Prime Cemented Hip SystemOrthopaedic Innovations, Inc. · 1995

All 8 as Orthopaedic Innovations, Inc. →