FDA applicant
Total Joint Orthopedics, Inc.
FDA records 23 decisions for Total Joint Orthopedics, Inc. (Salt Lake City, UT) from 2010 to 2026: 23 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 80 predicates, 43 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Total Joint Orthopedics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Total Joint Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Total Joint Orthopedics, 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