Data / Medical devices / United States / Total Joint Orthopedics, Inc.
Total Joint Orthopedics, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 29 510(k) clearances
Total Joint Orthopedics, Inc. is registered with the FDA (registration 3008544874) in Salt Lake City, UT, United States. It lists 22 device types. The FDA files 29 510(k) clearances under its listings, the newest dated July 23, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008544874
- Address
- 1567 E. Stratford Avenue, Salt Lake City, UT, United States, 84106
- Owner or operator
- Total Joint Orthopedics, Inc (10036774)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 24, 2011
- Registered through
- 2027
- Brand names listed
- 22mm BIOLOX delta Ceramic Femoral Head, 28mm BIOLOX OPTION Femoral Head, 16/18 taper, 28mm BIOLOX delta Ceramic Femoral Head, 3-in-1 Drill, 3.2mm Drill, 3.2mm Drill Tip, 3.2mm Drill with Stop, 3.2mm Stop Drill and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2026 | K261734 | Klassic Infection Spacer System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| March 24, 2025 | K243991 | Klassic Knee System - Revision Tibial Baseplate | JWH | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| September 8, 2023 | K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | JWH | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| May 19, 2023 | K230537 | Klassic Knee Revision System | JWH | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| September 23, 2022 | K220483 | Platform® Acetabular System | LZO | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| December 3, 2021 | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | LZO | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| July 23, 2021 | K211602 | Klassic Knee System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| October 9, 2020 | K202740 | Klassic Knee System Tibial Inserts, PS-Max | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| August 28, 2019 | K191399 | BIOLOX CONTOURA Ceramic Femoral Head | LZO | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| March 29, 2019 | K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| March 15, 2019 | K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| May 9, 2018 | K180929 | Klassic HD® Hip System | LZO | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| March 9, 2018 | K180159 | Klassic® Knee System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| October 27, 2017 | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | OQG | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| July 24, 2017 | K171962 | Klassic HD® Hip System | LPH | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| October 28, 2016 | K162422 | Klassic Knee System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| October 27, 2016 | K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | MBH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| October 19, 2016 | K161073 | Klassic HD Hip System | LPH | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| December 17, 2015 | K153310 | Klassic Knee System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| November 13, 2015 | K153075 | Klassic Knee System | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| September 3, 2015 | K151440 | Klassic HD Hip System | LPH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| February 17, 2015 | K150105 | Klassic Knee System-Sombrero Patella | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| January 28, 2015 | K143113 | Klassic BiPolar System | KWY | Substantially Equivalent | Total Joint Orthopedics | accessdata.fda.gov |
| December 23, 2014 | K143407 | Klassic HD Hip System | LZO | Substantially Equivalent | Total Joint Othopedics, Inc. | accessdata.fda.gov |
| October 9, 2014 | K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | OQG | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| May 16, 2014 | K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| March 13, 2014 | K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS | LPH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| February 1, 2012 | K112906 | KLASSIC KNEE SYSTEM | JWH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
| December 3, 2010 | K100445 | KLASSIC HD HIP SYSTEM | LPH | Substantially Equivalent | Total Joint Orthopedics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 23, 2025 | 97708 | Class II | Ongoing | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Hea | 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. | accessdata.fda.gov |
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Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.