Consensus Knee System

FDA UDI

Class II (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: Consensus Knee System FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: Tibial Insert, PCL Substituting, R, 1-2, 10mm FDA UDI
Model / Reference: 2142-0-1210 FDA UDI
Description: Tibial Insert, PCL Substituting, R, 1-2, 10mm FDA UDI

Identifiers

Catalog Number: 2142-0-1210 FDA UDI
Primary DI / UDI-DI: 00840286815000 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

Yes

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

The Consensus Knee System is a high-performance, implantable knee joint prosthesis designed to articulate the femoral and tibial components of primary or revision bicondylar knee replacement. Featuring a one-piece contoured polyethylene insert or a more complex device with lateral rotation and anterior/posterior movement capabilities, this system provides superior flexion reproduction compared to traditional implants.

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: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI 5e2ba25e-ef64-47ba-ae0e-48871cebb344 35 fields · synced Jul 11, 2026