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TOTAL JOINT ORTHOPEDICS, INC.

Last updated September 17, 2026

Information

Page 42 of 42

Device	Model / Reference	Registries	Class	Status
Klassic Knee System	K211602	FDA 510(k)	Class II	Active
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly	K190280	FDA 510(k)	Class II	Active
Klassic Knee Tibial Stem Extension	K140942	FDA 510(k)	Class II	Active
Klassic HD Hip System	K143407	FDA 510(k)	Class II	Active
Klassic HD Hip System	K161073	FDA 510(k)	Class II	Active
Klassic Hd Hip System	K100445	FDA 510(k)	Class II	Active
Klassic Knee System - Revision Tibial Baseplate	K243991	FDA 510(k)	Class II	Active
Klassic Knee System	K153075	FDA 510(k)	Class II	Active
Klassic Knee System-Sombrero Patella	K150105	FDA 510(k)	Class II	Active
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	K183596	FDA 510(k)	Class II	Active
Klassic Knee Revision System	K230537	FDA 510(k)	Class II	Active
Klassic Knee System	K112906	FDA 510(k)	Class II	Active
Klassic Hd Acetabular Insert With E-Link Poly	K141972	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 23, 2025	Z-0432-2026	—	open, classified	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.