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Sign in to claim this brandUNITED ORTHOPEDIC CORP.
US
Last updated May 24, 2026
What UNITED ORTHOPEDIC CORP. makes
United Orthopedic Corp. manufactures orthopedic implants for knee and hip replacements, including posterior-stabilized and cruciate-retaining total knee prostheses, modular hip femur prostheses, and metal-on-polyethylene hip systems. Their portfolio also includes trial components for knee and hip surgeries, such as reusable knee tibia trials and femoral stem trials, as well as bipolar femoral head components for hemiarthroplasty. Additional products include acetabular components, ceramic femoral heads, and tibial augments designed for revision surgeries.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) database. Their portfolio is regulated under US medical device laws, ensuring compliance with standards for orthopedic implants. The manufacturer operates from the United States, adhering to domestic and international regulatory requirements for orthopedic prosthetics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does United Orthopedic Corp. manufacture?
United Orthopedic Corp. specializes in orthopedic implants primarily for knee and hip replacements. Their product line includes posterior-stabilized and cruciate-retaining total knee prostheses, modular hip femur prostheses with coatings, metal-on-polyethylene total hip systems, and bipolar femoral head components for hemiarthroplasty. They also produce reusable trial components for knee and hip surgeries, such as knee tibia trials and femoral stem trials, as well as revision-specific devices like tibial augments and modular hip stems.
Where is United Orthopedic Corp. based, and how does that affect its regulatory compliance?
United Orthopedic Corp. is based in the United States, which means its devices are subject to FDA regulations. Since the company manufactures orthopedic implants, their products fall under FDA classification as either Class I or Class II devices, depending on risk level. This classification determines the regulatory pathway for authorization, ensuring compliance with US medical device laws and quality standards for orthopedic prosthetics.
Which regulatory registries list United Orthopedic Corp.’s devices?
United Orthopedic Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in compliance with US regulatory requirements. This listing is essential for monitoring device performance, recalls, and post-market surveillance.
How are United Orthopedic Corp.’s devices classified under FDA regulations?
United Orthopedic Corp.’s devices are classified under the FDA’s medical device regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification is based on factors like the device’s intended use, potential risks, and the body part it interacts with, such as knee or hip implants.
What kinds of hip and knee implants does United Orthopedic Corp. develop, and why are some designed for revision surgeries?
United Orthopedic Corp. develops a range of hip and knee implants, including total knee prostheses (both posterior-stabilized and cruciate-retaining), modular hip femur prostheses, and metal-on-polyethylene hip systems. Some devices, like modular revision hip stems and tibial augments, are specifically designed for revision surgeries because they address complications from initial implants, such as loosening or bone loss. These revision-specific implants provide enhanced stability and customization to improve outcomes in complex cases.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- uoc.com.tw
- —
- —
- [email protected]
- Phone
- +886229294567
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 656700556
Catalogue (3555)
Page 6 of 72| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| U-Motion II | 9206-5036-TA | FDA UDI | Class I | Active |
| USTAR II Knee System | 2715-8710 | FDA UDI | Class II | Active |
| U2™ Knee | 2303-4075 | FDA UDI | Class II | Active |
| U2 Hip Stem | 1104-2413 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2823-2112 | FDA UDI | Class II | Active |
| U2 Femoral Head | 1206-2628-RB | FDA UDI | Class II | Active |
| UTF™ Stem | 9106-6013 | FDA UDI | Class II | Active |
| U2 Total Knee System | 9323-8109 | FDA UDI | Class II | Active |
| Resolve Modular Revision Hip Stem | 1112-5024 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2203-4210-RG | FDA UDI | Class II | Active |
| U2 Total Knee System | 2203-3610 | FDA UDI | Class II | Active |
| Resolve Modular Revision Hip Stem | 1112-5128 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2103-4215 | FDA UDI | Class II | Active |
| U2 Total Knee System | 9323-5312 | FDA UDI | Class I | Active |
| U2 Total Knee System | 9423-5020 | FDA UDI | Class II | Active |
| E-XPE Tibial insert, PSA | 2303-5854 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2303-3520 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2303-3542 | FDA UDI | Class II | Active |
| Resolve Modular Revision Hip Stem | 1112-1819 | FDA UDI | Class II | Active |
| U2™ Knee | 9304-2003-RA | FDA UDI | Class I | Active |
| U2 Total Knee System | 2703-6064-RB | FDA UDI | Class II | Active |
| UTF™ Stem | 9106-1111 | FDA UDI | Class I | Active |
| Femoral augment, Distal, Left Lateral/Right, Medial | 2603-5261 | FDA UDI | Class II | Active |
| E-XPE Tibial insert, PS | 2303-3814 | FDA UDI | Class II | Active |
| United Hip System, U-Motion II XPE Cup Liner | 1406-3850 | FDA UDI | Class II | Active |
| U2 Bipolar Implant | 1503-3340 | FDA UDI | Class II | Active |
| Straight stem, PSA type | 2703-5163 | FDA UDI | Class II | Active |
| Femoral augment, Distal, Left Lateral/Right, Medial | 2603-5231 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2303-1403 | FDA UDI | Class II | Active |
| E-XPE Tibial insert, PSA | 2303-5857 | FDA UDI | Class II | Active |
| U1 Hip System, Bipolar Cup | 1501-1054 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2823-2243 | FDA UDI | Class II | Active |
| U2 Total Knee System | 9303-8010-RT | FDA UDI | Class II | Active |
| USTAR II Knee System | 2715-8113 | FDA UDI | Class II | Active |
| Resolve Modular Revision Hip Stem | 1112-7012 | FDA UDI | Class II | Active |
| Straight stem, PSA type | 2703-5186 | FDA UDI | Class II | Active |
| U2 Total Knee System | 9403-2123-RF | FDA UDI | Class I | Active |
| United Hip System | 1110-1404 | FDA UDI | Class II | Active |
| United Cement Restrictor | 1905-7008 | FDA UDI | Class II | Active |
| U1 Hip System, Acetabular Cup | 1301-1060 | FDA UDI | Class II | Active |
| United Hip System, U2 Bipolar Implant | 1503-3043 | FDA UDI | Class II | Active |
| USTAR II Knee System | 2125-2150 | FDA UDI | Class II | Active |
| U1 Hip System | 1201-2526 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2303-3514 | FDA UDI | Class II | Active |
| Resolve Modular Revision Hip Stem | 1112-7122 | FDA UDI | Class II | Active |
| XPE Tibial Insert, PS | 2303-3651 | FDA UDI | Class II | Active |
| E-XPE Tibial insert, PS | 2303-3815 | FDA UDI | Class II | Active |
| U2™ Knee | 2303-4073 | FDA UDI | Class II | Active |
| U2 Total Knee System | 2303-3532 | FDA UDI | Class II | Active |
| U1 Hip System, Acetabular Cup Liner | 1401-1048 | FDA UDI | Class II | Active |
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