HemiCAP®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name: HemiCAP® FDA UDI
Generic Name: Coated hip femur prosthesis, modular FDA UDI
Device Name: 35mm Art. Comp., 6.5 x 6.5, Femoral Head CE FDA UDI
Model / Reference: H352-0065-W FDA UDI
Description: 35mm Art. Comp., 6.5 x 6.5, Femoral Head CE FDA UDI

Identifiers

Catalog Number: H352-0065-W FDA UDI
Primary DI / UDI-DI: M528H3520065W0 FDA UDI
510(k) Number: K021549 FDA UDI
FDA Product Code: KXA FDA UDI
GMDN Term: Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3400 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 — 35 Millimeter FDA UDI

Category: Coated hip femur prosthesis, modular

HemiCAP® by Arthrosurface Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated hip femur prosthesis, modular.

LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
ABG — Howmedica Osteonics Corp. · Class II
Z1™ Hip System — Zimmer, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
VerSys® — Zimmer, Inc. · Class II
CATALYSTEM — Smith & Nephew, Inc. · Class II
Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Excia® L — AESCULAP, INC. · Class II

Cleared under the same submission

K021549 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

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Manufacturer

Manufacturer: Arthrosurface Incorporated

Sources (1)

FDA UDI 0fa6ba6c-9abe-4954-a6eb-795c1f4c59e6 37 fields · synced Jun 1, 2026