Advance®

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: ADVANCE® FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 5 RIGHT 14mm FDA UDI
Model / Reference: KIMP514R FDA UDI
Description: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 5 RIGHT 14mm FDA UDI

Identifiers

Catalog Number: KIMP514R FDA UDI
Primary DI / UDI-DI: M684KIMP514R1 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 14 Millimeter FDA UDI

Category: Tibial insert

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

Similar devices

Also classified as Tibial insert.

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Maxim Knee System — Biomet Orthopedics, Inc. · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · 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 0be4326a-d8b8-4f83-9807-4bb4e26aea3d 36 fields · synced Jun 9, 2026