← Back to catalogue
U1 Hip System, Acetabular Cup Liner
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K994078
Identity
- Trade Name
- U1 Hip System, Acetabular Cup Liner FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- U1 Acetabular cup liner assembly, 20°hooded,52mm FDA UDI
- Model / Reference
- 1401-1052 FDA UDI
- Description
- U1 Acetabular cup liner assembly, 20°hooded,52mm FDA UDI
Identifiers
- Catalog Number
- 1401-1052 FDA UDI
- Primary DI / UDI-DI
- 04712602343039 FDA UDI
- 510(k) Number
- K994078 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
Dimensions & Sizes
- Size
- Outer Diameter — 52 Millimeter FDA UDI
Category: Metal-on-polyethylene total hip prosthesis
U1 Hip System, Acetabular Cup Liner by United Orthopedic Corp. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
Cleared under the same submission
K994078 also covers:
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Acetabular Cup — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Acetabular Cup — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Acetabular Cup — UNITED ORTHOPEDIC CORP.
- U1 Hip System, Acetabular Cup — UNITED ORTHOPEDIC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994078 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 1d065dc1-8b19-40fd-9fde-af934e3df179 61 fields · synced Jun 18, 2026
- FDA 510(k) K994078 1 fields · synced May 22, 2026