Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Metal-backed patella prosthesis FDA UDI
Device Name: PATELLA, AM POROUS METAL BACKED, 29mm, E-PLUS FDA UDI
Model / Reference: 110-03-729 FDA UDI
Description: PATELLA, AM POROUS METAL BACKED, 29mm, E-PLUS FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446337393 FDA UDI
510(k) Number: K212941 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
GMDN Term: Metal-backed patella prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 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

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

Category: Metal-backed patella prosthesis

Djo Surgical by Encore Medical, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-backed patella prosthesis.

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LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
Triathlon — Howmedica Osteonics Corp. · Class II
Triathlon — Howmedica Osteonics Corp. · Class II
LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
NEXGEN® TRABECULAR METAL® — Zimmer, Inc. · Class II

Cleared under the same submission

K212941 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: Encore Medical, L.p.

Sources (1)

FDA UDI 0b4ea1e8-1619-4f63-bedd-1f5b4cf34f75 34 fields · synced May 30, 2026