Identity
- Trade Name
- Biomet® Cemented Cup Hip System FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- XL-213666 FDA UDI
Identifiers
- Catalog Number
- XL-213666 FDA UDI
- Primary DI / UDI-DI
- 00887868343353 FDA UDI
- 510(k) Number
- K042051 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 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: Non-constrained polyethylene acetabular liner
Biomet® Cemented Cup Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
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- PRIME — MicroPort Orthopedics Inc. · Class II
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- Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II
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- Libertas — MAXX ORTHOPEDICS INC. · Class II
Cleared under the same submission
K042051 also covers:
- BIOMET CEMENTED CUP HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET CEMENTED CUP HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET CEMENTED CUP HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET CEMENTED CUP HIP SYSTEM — Biomet Orthopedics, Inc.
- BIOMET CEMENTED CUP HIP SYSTEM — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup Hip System — Biomet Orthopedics, Inc.
- Biomet® Cemented Cup 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 48cb0779-a7ef-41f7-b366-5689420dc2ea 36 fields · synced Jun 1, 2026