All poly tibial component, PS
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- U2 Total Knee System EUDAMEDAll poly tibial component, PS FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- U2 Total Knee System All Poly Tibial Component, Posterior Stabilized, #5, 13mm Thick EUDAMEDAll poly tibial component, PS, #5, 13mm FDA UDI
- Model / Reference
- 2203-1253 EUDAMEDFDA UDI
- Description
- All poly tibial component, PS, #5, 13mm FDA UDI
Identifiers
- Catalog Number
- 2203-1253 FDA UDI
- Primary DI / UDI-DI
- 04711605577915 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605577915 EUDAMED
- 510(k) Number
- K152430 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090903020301 BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK MADE OF POLYETHYLENE EUDAMED
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Posterior-stabilized total knee prosthesis
All poly tibial component, PS by United Orthopedic Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Posterior-stabilized total knee prosthesis.
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- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K152430 also covers:
- All poly tibial component, CR — UNITED ORTHOPEDIC CORP.
- All poly tibial component, PS — UNITED ORTHOPEDIC CORP.
- All poly tibial component, PS — UNITED ORTHOPEDIC CORP.
- All poly tibial component, UC — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI ae6db966-8e71-4ecb-926c-420bb7dd020f 37 fields · synced Oct 5, 2026
- EUDAMED 97b63f21-a187-4af3-930a-e62dffccaec3 61 fields · synced Oct 5, 2026