Total Joint Orthopedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
22
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0432-2026Class IIBrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm September 23, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K220483Platform® Acetabular SystemSeptember 23, 2022
K211877Klassic Knee SystemJune 22, 2022
K211602Klassic Knee SystemJuly 23, 2021
K202740Klassic Knee System Tibial Inserts, PS-MaxOctober 9, 2020
K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; KlaMarch 29, 2019
K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella wiMarch 15, 2019
K180929Klassic HD® Hip SystemMay 9, 2018
K180159Klassic® Knee SystemMarch 9, 2018
K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert wiOctober 27, 2017
K162422Klassic Knee SystemOctober 28, 2016
K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousOctober 27, 2016
K153310Klassic Knee SystemDecember 17, 2015
K153075Klassic Knee SystemNovember 13, 2015
K151440Klassic HD Hip SystemSeptember 3, 2015
K150105Klassic Knee System-Sombrero PatellaFebruary 17, 2015
K143113Klassic BiPolar SystemJanuary 28, 2015
K141972KLASSIC HD ACETABULAR INSERT WITH E-LINK POLYOctober 9, 2014
K140942KLASSIC KNEE TIBIAL STEM EXTENSIONMay 16, 2014
K133832KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUSMarch 13, 2014
K131454KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEADFebruary 12, 2014