Vivacit-E®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Vivacit-E® FDA UDI
Generic Name: Unicondylar knee insert FDA UDI
Model / Reference: 00-5842-096-12 FDA UDI

Identifiers

Catalog Number: 00-5842-096-12 FDA UDI
Primary DI / UDI-DI: 00889024517868 FDA UDI
510(k) Number: K122529 FDA UDI
FDA Product Code: HSX FDA UDI
OIY FDA UDI
GMDN Term: Unicondylar knee insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
888.3560 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: Height — 12.00 Millimeter FDA UDI

Category: Unicondylar knee insert

Vivacit-E® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unicondylar knee insert.

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Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
MOTO Partial Knee System - Medial — Medacta International · Class II
GENESIS — Smith & Nephew, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
GMK Uni — Medacta International · Class II
SIGMA — DEPUY (IRELAND) · Class II
GENESIS — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K122529 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 da5edb03-0108-4ac4-b1bc-995b45bbc3c5 36 fields · synced May 30, 2026