Agc Tradition Knee System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: AGC TRADITION KNEE SYSTEM FDA UDI
Generic Name: Posterior-stabilized total knee prosthesis FDA UDI
Model / Reference: 151037 FDA UDI

Identifiers

Catalog Number: 151037 FDA UDI
Primary DI / UDI-DI: 00880304240605 FDA UDI
510(k) Number: K781294 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Posterior-stabilized total knee prosthesis 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

FDA UDI

Category: Posterior-stabilized total knee prosthesis

A comprehensive and well-informed overview of the AGC Tradition Knee System, designed to replace damaged or degenerative knee joints with a sterile implantable artificial substitute. The system is suitable for total knee arthroplasty (TKA) or prosthesis revision cases where bone stock and mediolateral stability are good.

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Also classified as Posterior-stabilized total knee prosthesis.

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Evolution — MicroPort Orthopedics Inc. · Class II
Evolution — MicroPort Orthopedics Inc. · Class II
Consensus MBK System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 962c90ff-e770-4a8a-b9af-a7e72848fc63 36 fields · synced Jul 7, 2026