Evolution

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: Evolution FDA UDI
Generic Name: Posterior-stabilized total knee prosthesis FDA UDI
Device Name: EVOLUTION® MP ADAPTIVE PS INSER IMPLANT SZ 3/1 RIGHT 12MM FDA UDI
Model / Reference: EPI3112R FDA UDI
Description: EVOLUTION® MP ADAPTIVE PS INSER IMPLANT SZ 3/1 RIGHT 12MM FDA UDI

Identifiers

Catalog Number: EPI3112R FDA UDI
Primary DI / UDI-DI: M684EPI3112R1 FDA UDI
FDA Product Code: JWH FDA UDI
HRY FDA UDI
GMDN Term: Posterior-stabilized total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3530 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 12 Millimeter FDA UDI

Category: Posterior-stabilized total knee prosthesis

Evolution by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-stabilized total knee prosthesis.

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Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Klassic Tibial Insert, PS-Max, Std Poly — TOTAL JOINT ORTHOPEDICS, INC. · Class II
Tibial Revision Platform — CPM Medical Consultants, LLC · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

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: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI 9f26e539-08cb-47c9-be50-94a82c662f76 36 fields · synced Jun 9, 2026