U1 Hip System, Femoral Head

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: U1 Hip System, Femoral Head FDA UDI
Generic Name: Metal-on-polyethylene total hip prosthesis FDA UDI
Device Name: U1 Hip System, Femoral head, OD28mm, +2.5mm FDA UDI
Model / Reference: 1201-1228 FDA UDI
Description: U1 Hip System, Femoral head, OD28mm, +2.5mm FDA UDI

Identifiers

Catalog Number: 1201-1228 FDA UDI
Primary DI / UDI-DI: 04712771497380 FDA UDI
510(k) Number: K122504 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 28 Millimeter FDA UDI

Category: Metal-on-polyethylene total hip prosthesis

U1 Hip System, Femoral Head by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — 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

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: United Orthopedic Corp.

Sources (1)

FDA UDI 0f2869a4-d4e2-45bf-a4bf-b834352c2340 37 fields · synced May 31, 2026