Amk

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: AMK FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: AMK TOTAL KNEE SYSTEM TIBIAL INSERT FIXED BEARING CONSTRAINED SIZE 4 10mm FDA UDI
Model / Reference: 1688-61-025 FDA UDI
Description: AMK TOTAL KNEE SYSTEM TIBIAL INSERT FIXED BEARING CONSTRAINED SIZE 4 10mm FDA UDI

Identifiers

Catalog Number: 168861025 FDA UDI
Primary DI / UDI-DI: 10603295067191 FDA UDI
510(k) Number: K864671 FDA UDI
K910940 FDA UDI
K910992 FDA UDI
K944538 FDA UDI
K954684 FDA UDI
FDA Product Code: JDB FDA UDI
JDI FDA UDI
KWT FDA UDI
HRY FDA UDI
HSX FDA UDI
JWH FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3160 FDA UDI
888.3350 FDA UDI
888.3650 FDA UDI
888.3530 FDA UDI
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

Category: Tibial insert

Amk by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibial insert.

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P.F.C. SIGMA — DEPUY (IRELAND) · Class II
Truliant, Activit-E — Exactech, Inc. · Class II
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

Cleared under the same submission

K864671 also covers:

K910940 also covers:

K910992 also covers:

K944538 also covers:

K954684 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: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 47552b23-08fc-4add-899b-e42ad2939b31 36 fields · synced Jun 8, 2026