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Consensus Knee System with TiNbN

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K241180

by Shalby Advanced Technologies

Identity

Trade Name
Consensus Knee System with TiNbN FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 3 FDA UDI
Model / Reference
2294-0-0003 FDA UDI
Description
CKS, Tibial Baseplate, Pegged, TiNbN Coating, Right, Size 3 FDA UDI

Identifiers

Catalog Number
2294-0-0003 FDA UDI
Primary DI / UDI-DI
00840286852050 FDA UDI
510(k) Number
K241180 FDA 510(k)FDA UDI
FDA Product Code
JWH FDA 510(k)FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Consensus Knee System with TiNbN by Shalby Advanced Technologies — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shalby Advanced Technologies

Sources (2)

  • FDA 510(k) K241180 24 fields · synced Jun 18, 2026
  • FDA UDI 190252f5-92b6-4086-9f46-d5ff2a263bca 36 fields · synced May 27, 2026