Cleared Special

K260796 - Tahoe Unicondylar Knee System with TiNbN Overcoat (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260796 · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
22d
Days
Class 2
Risk

K260796 is an FDA 510(k) clearance for the Tahoe Unicondylar Knee System with TiNbN Overcoat. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics (El Dorado Hills, US). The FDA issued a Cleared decision on April 2, 2026 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics devices

Submission Details

510(k) Number K260796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2026
Decision Date April 02, 2026
Days to Decision 22 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K260796.
Cambridge Partial Knee
K251771 · Signature Orthopaedics Pty, Ltd. · Dec 2025
Persona Partial Knee
K251834 · Zimmer Biomet · Aug 2025
MOTO Partial Knee System Extension
K251618 · Medacta International S.A. · Jul 2025
Arthrex iBalance Partial Knee System
K251453 · Arthrex, Inc. · Jul 2025
ACTIFY™ Unicondylar Knee System
K241260 · Globus Medical, Inc. · Dec 2024
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
K242711 · Smith & Nephew, Inc. · Oct 2024