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FDA 510(k)

Tahoe Unicondylar Knee System with TiNbN Overcoat

K-Number: K260796 · 2026-04-02

ApplicantShalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Decision Date2026-04-02
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tahoe Unicondylar Knee System with TiNbN Overcoat is a medical device manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It received FDA 510(k) clearance on 2026-04-02 under approval number K260796. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tahoe Unicondylar Knee System with TiNbN Overcoat?

Tahoe Unicondylar Knee System with TiNbN Overcoat is a medical device that received FDA 510(k) clearance on 2026-04-02. It is manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The 510(k) number is K260796.

When was Tahoe Unicondylar Knee System with TiNbN Overcoat approved by the FDA?

Tahoe Unicondylar Knee System with TiNbN Overcoat received FDA 510(k) clearance on 2026-04-02, under approval number K260796.

What company makes Tahoe Unicondylar Knee System with TiNbN Overcoat?

Tahoe Unicondylar Knee System with TiNbN Overcoat is manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics.

What is the FDA product code for Tahoe Unicondylar Knee System with TiNbN Overcoat?

The FDA product code for Tahoe Unicondylar Knee System with TiNbN Overcoat is HSX.

Other Devices by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

K252846TaperSet™ Hip System

Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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