HemiCAP®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name: HemiCAP® FDA UDI
Generic Name: Partial metatarsophalangeal joint prosthesis FDA UDI
Device Name: 12mm Art Comp 2.0mm x 2.5mm, MTP CE FDA UDI
Model / Reference: 9122-2025-W FDA UDI
Description: 12mm Art Comp 2.0mm x 2.5mm, MTP CE FDA UDI

Identifiers

Catalog Number: 9122-2025-W FDA UDI
Primary DI / UDI-DI: M52891222025W0 FDA UDI
510(k) Number: K063370 FDA UDI
FDA Product Code: KWD FDA UDI
GMDN Term: Partial metatarsophalangeal joint prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3730 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 — 12 Millimeter FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

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

Similar devices

Also classified as Partial metatarsophalangeal joint prosthesis.

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MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
TOE NON POROUS COATED SMALL 17mm — BIOPRO, INC. · Class II
Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
OsteoMed — Osteomed Corp. · U
Arthrex® — Arthrex, Inc. · Class II
MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · 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: Arthrosurface Incorporated

Sources (1)

FDA UDI ba8d9f93-1ad3-43a1-9de6-c463514f1b41 37 fields · synced May 30, 2026