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Tahoe Uni Knee System

by Consensus Orthopedics, Inc.

510(k) K170344

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 · Traditional NumberK170344 Date5 Oct 2017ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 Uni Knee System is a femorotibial knee prosthesis that provides a non‑constrained, cemented articulation using metal and polymer components. It is designed for implantation as a total knee replacement to restore joint function and stability in patients requiring orthopedic surgical intervention.

The system was cleared through a traditional FDA 510(k) pathway (K170344) as substantially equivalent to a predicate device, classified as a Class II prosthesis (product code HSX). It is supplied by Consensus Orthopedics, Inc. for single‑use implantation, conforms to the regulatory definition of a cemented knee prosthesis, and is intended for use in a sterile surgical environment under the oversight of the Orthopedic advisory committee.

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Questions

AI-generated answers, 1 Oct 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 Uni Knee System used for?

    The Tahoe Uni Knee System is a femorotibial knee prosthesis designed for implantation as a total knee replacement to restore joint function and stability in patients requiring orthopedic surgical intervention.

  • How is the Tahoe Uni Knee System supplied?

    The system is supplied by Consensus Orthopedics, Inc. for single-use implantation in a sterile surgical environment under the oversight of the Orthopedic advisory committee.

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

    The system was cleared through a traditional FDA 510(k) pathway (K170344) as substantially equivalent to a predicate device, classified as a Class II prosthesis (product code HSX).

  • What type of articulation does the Tahoe Uni Knee System provide?

    The Tahoe Uni Knee System provides a non-constrained, cemented articulation using metal and polymer components for total knee replacement procedures.