Question 1

What types of medical devices does Total Joint Orthopedics, Inc. manufacture?

Accepted Answer

Total Joint Orthopedics, Inc. specializes in reusable orthopedic trial components and instruments primarily for knee and hip arthroplasty procedures. Their portfolio includes knee tibia and acetabulum prosthesis trials, tibial inserts, posterior-stabilized knee prosthesis trials, acetabular liner trials, knee arthroplasty wedges, and specialized instruments like positioning tools and hip reamers. These devices are designed to assist surgeons during trial implantations and surgical planning.

Question 2

Where is Total Joint Orthopedics, Inc. based, and what does that mean for their regulatory standing?

Accepted Answer

Total Joint Orthopedics, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based categories (Class I or Class II) and potential listing in the FDA’s Unique Device Identifier (UDI) database. The U.S. regulatory environment ensures these devices meet specific safety and performance standards before they are authorized for use.

Question 3

Which regulatory registries or databases list devices manufactured by Total Joint Orthopedics, Inc.?

Accepted Answer

Devices from Total Joint Orthopedics, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, helping track and monitor their distribution and use. This listing is part of the FDA’s efforts to improve device transparency and traceability in the healthcare system.

Question 4

How are the devices manufactured by Total Joint Orthopedics, Inc. classified under FDA regulations?

Accepted Answer

The devices produced by Total Joint Orthopedics, Inc. are classified under the FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may be subject to general controls, while Class II devices require additional regulatory controls due to moderate risk. The classification is determined based on factors like the device’s intended use, potential harm if it fails, and the duration of use, ensuring appropriate oversight aligns with their risk profile.

Device	Model / Reference	Registries	Class	Status
Klassic Tibial Insert, Ultra-PS, E-Link Poly	5303.04.013	FDA UDI	Class II	Active
Stem Trial	2015.19.070	FDA UDI	Class I	Active
Platform Acetabular Cup with Ti-Coat	3401.64.000	FDA UDI	Class II	Active
Klassic Tibial Augment & Screw	6405.01.005	FDA UDI	Class II	Active
Tibial Baseplate Trial	2204.06.000	FDA UDI	Class I	Active
Patella Caliper, Klassic ONE	2314.00.000	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Post, Klassic ONE	2254.03.024	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Max, Klassic ONE	2252.01.014	FDA UDI	Class I	Active
Calcar Planer	1327.42.000	FDA UDI	Class I	Active
Intramedullary Reamer, Revision	2026.11.000	FDA UDI	Class I	Active
Tibial Insert Trial	2205.03.018	FDA UDI	Class I	Active
Klassic Blade Femoral Canal Finder Rasp, Curved	1337.00.000	FDA UDI	Class I	Active
Klassic Knee Femur, Revision	6100.06.000	FDA UDI	Class II	Active
T-Handle	1330.00.000	FDA UDI	Class I	Active
Femoral Head Trial	1306.32.000	FDA UDI	Class I	Active
Klassic Knee Femur, Revision	6100.04.000	FDA UDI	Class II	Active
BiPolar Femoral Head Trial	1326.22.000	FDA UDI	Class I	Active
Straight Shaft Cup Inserter	1206.00.000	FDA UDI	Class I	Active
Stem Trial	2015.17.100	FDA UDI	Class I	Active
Tibial Insert Trial, Klassic ONE	2240.04.014	FDA UDI	Class I	Active
Klassic BiPolar Instrument Set Sterilization Case	1404.00.000	FDA UDI	Class I	Active
Klassic Femoral Augment, Distal	6402.04.010	FDA UDI	Class II	Active
Guide Pin, Triangle Head	2709.00.076	FDA UDI	Class I	Active
Klassic Knee Tibial Insert, Ultra-PS, Size 4, 18 mm, Final Packed, Sterile	5301.04.018	FDA UDI	Class II	Active
Klassic Knee Tibial Insert, CR/Congruent, Size 4, 10 mm, Final Packed, Sterile	5300.04.010	FDA UDI	Class II	Active
Klassic Knee Sombrero Patella w/E-Link	5503.05.010	FDA UDI	Class II	Active
Tibial Insert Trial, PS-Post, Klassic ONE	2254.05.021	FDA UDI	Class I	Active
Stem Trial	2015.16.070	FDA UDI	Class I	Active
BIOLOX CONTOURA Ceramic Femoral Head	3206.32.350	FDA UDI	Class II	Active
Tibial Insert Trial, Klassic ONE	2240.05.011	FDA UDI	Class I	Active
Tibial Broach Stem	2203.00.150	FDA UDI	Class I	Active
Klassic Tibial Insert, PS-Post, E-Link	5305.01.010	FDA UDI	Class II	Active
Acetabular Insert with E-Link Poly, 36mm Head, Size 54mm	3502.54.036	FDA UDI	Class II	Active
Klassic Knee Tibial Insert, CR/Congruent, Size 4, 12 mm, Final Packed, Sterile	5300.04.012	FDA UDI	Class II	Active
Klassic Tibial Insert, Ultra-PS, E-Link Poly	5303.04.014	FDA UDI	Class II	Active
Femur Trial	2147.05.000	FDA UDI	Class I	Active
Femur Trial	2147.07.000	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Max, Klassic ONE	2252.01.020	FDA UDI	Class I	Active
Klassic ONE Stem Trial Caddy for PS-Max Stem + Augment Instrument Tray	2414.00.100	FDA UDI	Class I	Active
Stem Trial	2015.19.150	FDA UDI	Class I	Active
36mm Femoral Head, 12/14 Taper, -3.5mm Offset	3200.36.035	FDA UDI	Class II	Active
Klassic BiPolar Trial	1340.53.028	FDA UDI	Class I	Active
Klassic Knee System Femoral Peg	5107.00.000	FDA UDI	Class II	Active
Tibial Insert Trial	2205.06.014	FDA UDI	Class I	Active
Platform Hooded Acetabular Insert with E-Link	3512.50.036	FDA UDI	Class II	Active
Patella Drill Guide/Sizer, Klassic ONE	SRI-10037-03	FDA UDI	Class I	Active
Tibial Insert Trial, PS-Max, Klassic ONE	2252.05.012	FDA UDI	Class I	Active
Acetabular Screw Holding Forceps	1221.00.000	FDA UDI	Class I	Active
Stem Trial	2015.20.100	FDA UDI	Class I	Active
Femur Extractor/Impactor	2109.00.000	FDA UDI	Class I	Active

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