E-XPE Cemented cup

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: E-XPE Cemented cup FDA UDI
Generic Name: Polyethylene acetabulum prosthesis FDA UDI
Device Name: E-XPE Cemented cup, I.D. 32mm, O.D. 60mm FDA UDI
Model / Reference: 1302-5260 FDA UDI
Description: E-XPE Cemented cup, I.D. 32mm, O.D. 60mm FDA UDI

Identifiers

Catalog Number: 1302-5260 FDA UDI
Primary DI / UDI-DI: 04719872147855 FDA UDI
510(k) Number: K172833 FDA UDI
FDA Product Code: KWY FDA UDI
LWJ FDA UDI
JDI FDA UDI
MEH FDA UDI
LZO FDA UDI
OQI FDA UDI
GMDN Term: Polyethylene acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3360 FDA UDI
888.3350 FDA UDI
888.3353 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 — 60 Millimeter FDA UDI

Category: Polyethylene acetabulum prosthesis

E-XPE Cemented cup by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene acetabulum prosthesis.

ZCA® — Zimmer, Inc. · Class II
Acetabular Insert — Howmedica Osteonics Corp. · Class II
Cenator Total Hip System — CORIN LTD · Class II
Exeter — Howmedica Osteonics Corp. · Class II
Exeter — Howmedica Osteonics Corp. · Class II
ZCA® — Zimmer, Inc. · Class II
REFLECTION — Smith & Nephew, Inc. · Class II
ZCA® — Zimmer, Inc. · Class II

Cleared under the same submission

K172833 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: United Orthopedic Corp.

Sources (1)

FDA UDI a24f9935-dbb6-454a-bbca-ab99a487346c 37 fields · synced Jun 1, 2026