Tahoe Unicondylar Knee System with TiNbN Overcoat— 510(k) K260796

Name: FDA 510(k) clearance K260796
Creator: U.S. Food and Drug Administration
Published: 2026-04-02

Substantially Equivalent

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

FDA 510(k) clearance K260796 for Tahoe Unicondylar Knee System with TiNbN Overcoat, Substantially Equivalent on 2026-04-02. Applicant: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. Device class: 2.

Clearance details

Applicant: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2026-03-11
Decision date: 2026-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.