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TOTAL JOINT ORTHOPEDICS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 1567 E. Stratford Avenue, Salt Lake City, UT, 84106
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EUDAMED SRN: —
FDA FEI Number: 3008544874
DUNS Number: —

Catalogue (2063)

Page 13 of 42

Device	Model / Reference	Registries	Class	Status
Tibial Insert Trial	2205.03.012	FDA UDI	Class I	Active
Stem Trial	2015.19.100	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Post, Klassic ONE	2254.04.010	FDA UDI	Class I	Active
Femoral Cut Block, Pegless	2148.06.000	FDA UDI	Class I	Active
Tibial Alignment Guide - Lower Tower, Klassic ONE, Ankle Strap	2233.00.100	FDA UDI	Class I	Active
Klassic Tibial Insert, Ultra-PS, E-Link Poly,	5303.05.018	FDA UDI	Class II	Active
Klassic HD Hooded Acetabular Insert with E-Link Poly	3507.64.036	FDA UDI	Class II	Active
Klassic BiPolar Trial	1340.40.022	FDA UDI	Class I	Active
Klassic BiPolar Trial	1322.42.022	FDA UDI	Class I	Active
28mm BIOLOX delta Ceramic Femoral Head, 12/14 taper	3203.28.350	FDA UDI	Class II	Active
3.2mm Drill Tip	1219.45.032	FDA UDI	Class I	Active
Klassic BiPolar Trial	1322.59.028	FDA UDI	Class I	Active
Klassic Femoral Augment, Posterior	6400.07.005	FDA UDI	Class II	Active
Femoral Cut Block	2106.02.000	FDA UDI	Class I	Active
Klassic Tibial Insert, CR/Congruent, E-Link Poly	5302.06.018	FDA UDI	Class II	Active
Klassic Tibial Baseplate with Ti-Coat, size 6	5202.06.000	FDA UDI	Class II	Active
Klassic Tibial Insert, Ultra-PS, E-Link Poly	5303.03.018	FDA UDI	Class II	Active
Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 64mm	3501.64.032	FDA UDI	Class II	Active
Klassic Tibial Baseplate, Revision	6200.02.000	FDA UDI	Class II	Active
Femoral Trial, PS-Post/Revision, Klassic ONE	2164.07.000	FDA UDI	Class I	Active
Drill and Pin Set, Sharp, Non-Sterile	2604.00.002	FDA UDI	Class I	Active
Platform Neutral Acetabular Insert with E-Link	3511.62.036	FDA UDI	Class II	Active
Femoral Stem Adapter Trial	2803.00.000	FDA UDI	Class I	Active
Klassic Knee Tibial Insert, CR/Congruent, Size 1, 10 mm, Final Packed, Sterile	5300.01.010	FDA UDI	Class II	Active
Klassic Stem Extension, Cemented	6600.12.200	FDA UDI	Class II	Active
Klassic HD Hip System Offset Femoral Stem, Porous, size 6	3103.06.000	FDA UDI	Class II	Active
Klassic HD Low Profile Acetabular Insert with XLPE Poly	3510.50.032	FDA UDI	Class II	Active
Tibial Insert Trial, PS-Max, Klassic ONE	2252.03.020	FDA UDI	Class I	Active
Stem Trial	2015.17.050	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Post, Klassic ONE	2254.01.024	FDA UDI	Class I	Active
Klassic Knee Tibial Insert, CR/Congruent, Size 2, 16 mm, Final Packed, Sterile	5300.02.016	FDA UDI	Class II	Active
BIOLOX CONTOURA Ceramic Femoral Head	3206.32.035	FDA UDI	Class II	Active
BiPolar Femoral Head Trial	1326.22.700	FDA UDI	Class I	Active
Tibial Insert Trial, Klassic ONE	2240.06.012	FDA UDI	Class I	Active
Stem Trial	2015.17.150	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Post	2224.03.011	FDA UDI	Class I	Active
Hemispherical Acetabular Reamer	1207.52.000	FDA UDI	Class I	Active
Cone Reamer Guide	2024.00.075	FDA UDI	Class I	Active
Klassic HD Low Profile Acetabular Insert with E-Link Poly	3509.64.032	FDA UDI	Class II	Active
Contoura Femoral Head Trial	1347.36.000	FDA UDI	Class I	Active
Stem Trial	2015.11.170	FDA UDI	Class I	Active
Revision Modular Tibial Broach	2905.05.000	FDA UDI	Class I	Active
Patella Trial	2303.03.000	FDA UDI	Class I	Active
Klassic Blade Femoral Stem, Porous, Size 1	3105.01.000	FDA UDI	Class II	Active
Klassic HD Modular Femoral Broach	1106.05.000	FDA UDI	Class I	Active
Klassic Stem Extension, Cemented	6600.10.070	FDA UDI	Class II	Active
Spiked Upper Tibial Tower	2214.00.000	FDA UDI	Class I	Active
Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 48mm	3501.48.032	FDA UDI	Class II	Active
Acetabular Insert Trial	1204.62.036	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Post	2224.03.021	FDA UDI	Class I	Active

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FDA Recalls (1)

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.