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Tahoe Unicondylar Knee System with TiNbN Overcoat

by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

510(k) K260796

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK260796 Date2 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tahoe Unicondylar Knee System is an orthopedic device with a fixed bearing design that reduces wear and promotes a more natural range of motion. It is designed for use in knee replacement procedures.

This device is supplied by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics and is classified as FDA class 2 with special regulation. It received FDA 510(k) clearance on April 2, 2026, with K number K260796, and is intended for orthopedic use.

Other devices from Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tahoe Unicondylar Knee System used for?

    The Tahoe Unicondylar Knee System is an orthopedic device with a fixed bearing design intended for use in knee replacement procedures. It reduces wear and promotes a more natural range of motion.

  • How is the Tahoe Unicondylar Knee System supplied?

    The device is supplied by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It is classified as FDA class 2 with special regulation and received FDA 510(k) clearance on April 2, 2026.

  • What is the regulatory status of the Tahoe Unicondylar Knee System?

    The device has received FDA 510(k) clearance with K number K260796, classified as substantially equivalent under special regulation. It is intended for orthopedic use and is classified as FDA class 2.

  • What are the key features of the Tahoe Unicondylar Knee System?

    The system features a fixed bearing design that reduces wear and promotes a more natural range of motion. It includes a TiNbN overcoat, which may enhance durability and performance in knee replacement procedures.