Identity
- Trade Name
- REGENEREX HIP SYSTEM FDA UDI
- Generic Name
- Metallic acetabulum prosthesis FDA UDI
- Model / Reference
- PT-210252 FDA UDI
Identifiers
- Catalog Number
- PT-210252 FDA UDI
- Primary DI / UDI-DI
- 00880304450165 FDA UDI
- 510(k) Number
- K052888 FDA UDI
- FDA Product Code
- MEH FDA UDIKWZ FDA UDILZO FDA UDILPH FDA UDIJDI FDA UDIMAY FDA UDI
- GMDN Term
- Metallic acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3310 FDA UDI888.3358 FDA UDI888.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metallic acetabulum prosthesis
Regenerex Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabulum prosthesis.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Dynasty — MicroPort Orthopedics Inc. · Class II
- Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- PROCOTYL® PRIME — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K052888 also covers:
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
- REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI da28e50b-3f0e-4914-b25a-0db391deccc1 36 fields · synced May 30, 2026