Zmr®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: ZMR® FDA UDI
Generic Name: Revision coated hip femur prosthesis FDA UDI
Model / Reference: 9921-180-33 FDA UDI

Identifiers

Catalog Number: 00-9921-180-33 FDA UDI
Primary DI / UDI-DI: 00889024156821 FDA UDI
510(k) Number: K031572 FDA UDI
K113296 FDA UDI
FDA Product Code: KWZ FDA UDI
JDI FDA UDI
LZO FDA UDI
LPH FDA UDI
LWJ FDA UDI
GMDN Term: Revision coated hip femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
888.3358 FDA UDI
888.3360 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

Category: Revision coated hip femur prosthesis

ZMR® is a sterile, revision-coated femoral component prosthesis designed to replace the entire femoral component of a total hip prosthesis typically due to wear. This device combines two or more separate segments (e.g., femoral head, neck, stem, and extensions) coated with porous materials intended to improve fixation and stability by promoting bone ingrowth.

Similar devices

Also classified as Revision coated hip femur prosthesis.

M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
M-Vizion Femoral Revision System — Medacta International · Class II

Cleared under the same submission

K031572 also covers:

K113296 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: Zimmer, Inc.

Sources (1)

FDA UDI 678f6e2c-070b-4028-a690-7ebfb3460c8f 36 fields · synced Jun 22, 2026