Total Joint Orthopedics, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3008544874
Total Joint Orthopedics, Inc. is a medical device manufacturer, with 2,113 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 2,113
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 2,082
- FDA 510(k) 31
- Device classes
- FDA Class I 1,152
- FDA Class II 961
- FDA recalls
- Identifiers
- FDA FEI 3008544874
What Total Joint Orthopedics, Inc. makes
Total Joint Orthopedics, Inc. manufactures reusable orthopedic trial components and instruments for knee and hip arthroplasty, including knee tibia and acetabulum prosthesis trials, tibial inserts, knee arthroplasty wedges, and positioning instruments. Their portfolio also includes posterior-stabilized knee prosthesis trials, acetabular liner trials, and specialized reamers for hip preparation.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 2,113 devicesShowing 1-50 of 2,113
Company details
- FDA FEI number
- 3008544874
- Address
- 1567 E. Stratford Avenue, Salt Lake City, UT, 84106
FDA recalls
FDA recall records list 1 recall initiated by TOTAL JOINT ORTHOPEDICS, INC., initiated on 2025-09-23. By recorded status: 1 ongoing. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 23 Sep 2025 Z-0432-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Frequently asked questions
How many devices does TOTAL JOINT ORTHOPEDICS, INC. have in the registry?
The registry currently lists 2113 devices for TOTAL JOINT ORTHOPEDICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TOTAL JOINT ORTHOPEDICS, INC.'s devices?
Among its 50 most recently registered devices, TOTAL JOINT ORTHOPEDICS, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TOTAL JOINT ORTHOPEDICS, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for TOTAL JOINT ORTHOPEDICS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for TOTAL JOINT ORTHOPEDICS, INC.?
FDA recall records list 1 recall initiated by TOTAL JOINT ORTHOPEDICS, INC., the most recent initiated on 23 Sep 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from TOTAL JOINT ORTHOPEDICS, INC. in the registry?
The most recently registered devices listed for TOTAL JOINT ORTHOPEDICS, INC. include Klassic Knee Template, Tibial Baseplate, Revision 2909.00.000, Modular Frog Eyes 2263.00.000, Distal Femoral Cut Block Connector 2174.00.000 and Distal Femoral Cut Guide with Short Pins SRI-10052.