HemiCAPDF-P®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name: HemiCAPDF-P® FDA UDI
Generic Name: Partial metatarsophalangeal joint prosthesis FDA UDI
Device Name: Modular Insert, 1.5mm Offset-01(3.6mm Thick) FDA UDI
Model / Reference: 9P15-PA01-W FDA UDI
Description: Modular Insert, 1.5mm Offset-01(3.6mm Thick) FDA UDI

Identifiers

Catalog Number: 9P15-PA01-W FDA UDI
Primary DI / UDI-DI: M5289F15PA01W0 FDA UDI
510(k) Number: K131377 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

Yes

FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

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

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Also classified as Partial metatarsophalangeal joint prosthesis.

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Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
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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 a1f6b902-8417-48d3-95a5-6fd9eae78dc9 36 fields · synced May 30, 2026