CKS Plus

FDA UDI

Class II (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: CKS Plus FDA UDI
Generic Name: Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name: Tibial BP, Cruciform, Hole, Full Wrap, L, 2 FDA UDI
Model / Reference: 2589-0-1102 FDA UDI
Description: Tibial BP, Cruciform, Hole, Full Wrap, L, 2 FDA UDI

Identifiers

Catalog Number: 2589-0-1102 FDA UDI
Primary DI / UDI-DI: 00840286825818 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Uncoated knee tibia prosthesis, metallic 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

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Manufacturing Date

FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

The CKS Plus is a high-performance, uncoated knee tibia prosthesis designed for primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis. It features a unique articulation design with an insert and/or the femoral prosthetic component, made from cobalt-chrome (Co-Cr) or cobalt-chrome-molybdenum (Co-Cr-Mo), for improved fixation and stability. The device has been labeled as 'No Risk of Magnetic Resonance Imaging Safety Information' and is marketed under the brand name CKS Plus.

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Natural-Knee® — Zimmer, Inc. · Class II
Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
Evolution — MicroPort Orthopedics Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
Optetrak — Exactech, Inc. · Class II
ATTUNE — DEPUY (IRELAND) · Class III
MOBIO™ Total Knee System — b-ONE Ortho Corp. · 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 f5131e41-a9e5-4a85-b329-be2dce7bf9d1 35 fields · synced Jul 12, 2026