510(k) Report

FDA applicant

Total Joint Othopedics, Inc.

Salt Lake City, UT8 decisions2014–20250 recalls

FDA records 8 decisions for Total Joint Othopedics, Inc. (Salt Lake City, UT) from 2014 to 2025: 8 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 3 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 Total Joint Othopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12016: 12017: 12019: 12021: 12023: 22025: 1
2014high 2 (2023) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Total Joint Othopedics, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Total Joint Othopedics, 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/Polymer3decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…3decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 81 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 20144cite it
  • K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc. · 20231cites it
  • K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 20161cites it
  • K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 20211cites it
  • K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc. · 20251cites it

What has FDA decided for it lately?

  • K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc. · 2025
  • K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc. · 2023
  • K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc. · 2023
  • K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
  • K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc. · 2019
  • K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc. · 2017
  • K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
  • K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014

All 8 as Total Joint Othopedics, Inc. →