Consensus Knee System with TiNbN 2289-0-0005

GUDID 00840286851725

CKS, Tibial Baseplate, Holed, TiNbN Coating, Left, Size 5

Shalby Advanced Technologies, Inc.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00840286851725
• NIH Device Record Key: 50a2e0af-bf4b-4e64-af4e-16950ceb91fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Knee System with TiNbN
• Version Model Number: 2289-0-0005
• Catalog Number: 2289-0-0005
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us
• Phone: 916-355-7100
• Email: khansen@shalby.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286851725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241180

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-27
• Device Publish Date: 2025-02-19

On-Brand Devices [Consensus Knee System with TiNbN]

• 00840286851664: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 6
• 00840286851657: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 5
• 00840286851640: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 4
• 00840286851633: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 3
• 00840286851626: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 2
• 00840286851619: CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 1
• 00840286851602: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 6
• 00840286851596: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 5
• 00840286851589: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 4
• 00840286851572: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 3
• 00840286851565: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 2
• 00840286851558: CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 1
• 00840286853125: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 5
• 00840286852074: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 6
• 00840286852067: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 4
• 00840286852050: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 3
• 00840286852043: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 2
• 00840286852036: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 1
• 00840286852029: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 0
• 00840286852012: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 6
• 00840286852005: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 5
• 00840286851992: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 4
• 00840286851985: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 3
• 00840286851978: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 2
• 00840286851961: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 1
• 00840286851954: CKS, Tibial Baseplate, Pegged, TiNbN Coating, Left, Size 0
• 00840286851947: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 6
• 00840286851930: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 5
• 00840286851923: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 4
• 00840286851916: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 3
• 00840286851909: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 2
• 00840286851893: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 1
• 00840286851886: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Right, Size 0
• 00840286851879: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 6
• 00840286851862: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 5
• 00840286851855: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 4
• 00840286851848: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 3
• 00840286851831: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 2
• 00840286851824: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 1
• 00840286851817: CKS, Tibial Baseplate, Pegless, TiNbN Coating, Left, Size 0
• 00840286851800: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 6
• 00840286851794: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 5
• 00840286851787: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 4
• 00840286851770: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 2
• 00840286851763: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 3
• 00840286851756: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 1
• 00840286851749: CKS, Tibial Baseplate, Holed, TiNbN Coating, Right, Size 0
• 00840286851732: CKS, Tibial Baseplate, Holed, TiNbN Coating, Left, Size 6
• 00840286851725: CKS, Tibial Baseplate, Holed, TiNbN Coating, Left, Size 5
• 00840286851718: CKS, Tibial Baseplate, Holed, TiNbN Coating, Left, Size 4