Total Joint Orthopedics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 22
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| Z-0432-2026 | Class II | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm | September 23, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K220483 | Platform® Acetabular System | September 23, 2022 |
| K211877 | Klassic Knee System | June 22, 2022 |
| K211602 | Klassic Knee System | July 23, 2021 |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | October 9, 2020 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Kla | March 29, 2019 |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella wi | March 15, 2019 |
| K180929 | Klassic HD® Hip System | May 9, 2018 |
| K180159 | Klassic® Knee System | March 9, 2018 |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert wi | October 27, 2017 |
| K162422 | Klassic Knee System | October 28, 2016 |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | October 27, 2016 |
| K153310 | Klassic Knee System | December 17, 2015 |
| K153075 | Klassic Knee System | November 13, 2015 |
| K151440 | Klassic HD Hip System | September 3, 2015 |
| K150105 | Klassic Knee System-Sombrero Patella | February 17, 2015 |
| K143113 | Klassic BiPolar System | January 28, 2015 |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | October 9, 2014 |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | May 16, 2014 |
| K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS | March 13, 2014 |
| K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD | February 12, 2014 |