Company · US
Total Joint Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 13 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2026 | K261734 | Klassic Infection Spacer System Total Joint Orthopedics, Inc. | JWH |
| Sep 23, 2022 | K220483 | Platform® Acetabular System Total Joint Orthopedics, Inc. | LZO |
| Jun 22, 2022 | K211877 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Jul 23, 2021 | K211602 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Oct 9, 2020 | K202740 | Klassic Knee System Tibial Inserts, PS-Max Total Joint Orthopedics, Inc. | JWH |
| Mar 29, 2019 | K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Ins Total Joint Orthopedics, Inc. | JWH |
| Mar 15, 2019 | K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly Total Joint Orthopedics, Inc. | JWH |
| May 9, 2018 | K180929 | Klassic HD® Hip System Total Joint Orthopedics, Inc. | LZO |
| Mar 9, 2018 | K180159 | Klassic® Knee System Total Joint Orthopedics, Inc. | JWH |
| Oct 27, 2017 | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly Total Joint Orthopedics, Inc. | OQG |
| Oct 28, 2016 | K162422 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Oct 27, 2016 | K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous Total Joint Orthopedics, Inc. | MBH |
| Dec 17, 2015 | K153310 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Nov 13, 2015 | K153075 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Sep 3, 2015 | K151440 | Klassic HD Hip System Total Joint Orthopedics, Inc. | LPH |
| Feb 17, 2015 | K150105 | Klassic Knee System-Sombrero Patella Total Joint Orthopedics, Inc. | JWH |
| Jan 28, 2015 | K143113 | Klassic BiPolar System Total Joint Orthopedics | KWY |
| Oct 9, 2014 | K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY Total Joint Orthopedics, Inc. | OQG |
| May 16, 2014 | K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION Total Joint Orthopedics, Inc. | JWH |
| Mar 13, 2014 | K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS Total Joint Orthopedics, Inc. | LPH |
| Feb 12, 2014 | K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD Total Joint Orthopedics, Inc. | LPH |
| Feb 1, 2012 | K112906 | KLASSIC KNEE SYSTEM Total Joint Orthopedics, Inc. | JWH |
| Dec 3, 2010 | K100445 | KLASSIC HD HIP SYSTEM Total Joint Orthopedics, Inc. | LPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | Total Joint Orthopedics, Inc. 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 Hea Open, Classified |
KWY | K143113 |