UniCAP®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name: UniCAP® FDA UDI
Generic Name: Unicondylar knee prosthesis FDA UDI
Device Name: 7.5mm x 18.5mm LG STUD, Uni-Femoral CE FDA UDI
Model / Reference: U075-0173-W FDA UDI
Description: 7.5mm x 18.5mm LG STUD, Uni-Femoral CE FDA UDI

Identifiers

Catalog Number: U075-0173-W FDA UDI
Primary DI / UDI-DI: M528U0750173W0 FDA UDI
510(k) Number: K050373 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Unicondylar knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 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 — 7.5 Millimeter FDA UDI

Category: Unicondylar knee prosthesis

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

Similar devices

Also classified as Unicondylar knee prosthesis.

Engage Partial Knee System — Engage Uni, LLC · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
GENESIS II — Smith & Nephew, 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 574e99b2-05db-4266-9d38-3d71d1e4436e 37 fields · synced May 30, 2026