Total Joint Orthopedics, Inc.
Salt Lake City, UT, US
TOTAL JOINT ORTHOPEDICS, INC. appears in FDA device records in Salt Lake City, UT. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Total Joint Orthopedics, Inc. between 2010 and 2026. The busiest year on record is 2015, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261734 | Klassic Infection Spacer System | JWH | Substantially Equivalent | |
| K220483 | Platform® Acetabular System | LZO | Substantially Equivalent | |
| K211877 | Klassic Knee System | JWH | Substantially Equivalent | |
| K211602 | Klassic Knee System | JWH | Substantially Equivalent | |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | JWH | Substantially Equivalent | |
| 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 | |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | JWH | Substantially Equivalent | |
| K180929 | Klassic HD® Hip System | LZO | Substantially Equivalent | |
| K180159 | Klassic® Knee System | JWH | Substantially Equivalent | |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | OQG | Substantially Equivalent | |
| K162422 | Klassic Knee System | JWH | Substantially Equivalent | |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | MBH | Substantially Equivalent | |
| K153310 | Klassic Knee System | JWH | Substantially Equivalent | |
| K153075 | Klassic Knee System | JWH | Substantially Equivalent | |
| K151440 | Klassic HD Hip System | LPH | Substantially Equivalent | |
| K150105 | Klassic Knee System-Sombrero Patella | JWH | Substantially Equivalent | |
| K143113 | Klassic BiPolar System | KWY | Substantially Equivalent | |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | OQG | Substantially Equivalent | |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | JWH | Substantially Equivalent | |
| K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS | LPH | Substantially Equivalent | |
| K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD | LPH | Substantially Equivalent | |
| K112906 | KLASSIC KNEE SYSTEM | JWH | Substantially Equivalent | |
| K100445 | KLASSIC HD HIP SYSTEM | LPH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008544874 | 3008544874 | TOTAL JOINT ORTHOPEDICS, INC. | 1567 E. Stratford Avenue, Salt Lake City, UT 84106 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- HTQBroach
- HWICorkscrew
- HWBExtractor
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- HWAImpactor
- LXHOrthopedic Manual Surgical Instrument
- OJHOrthopedic Tray
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HTOReamer
- HXXScrewdriver
- HWTTemplate
- HWKTrephine
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0432-2026 | 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 Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm OD, 28 mm Head; 3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head; 3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head; 3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head; 3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head; 3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head; 3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head; 3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head; 3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head; 3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head; 3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head | 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. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain