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Genius Total Knee System

by Signature Orthopaedics Pty Ltd

510(k) K170613

Genius Total Knee System is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K170613 on 17 Jul 2017, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170613 Date17 Jul 2017ClearedStatusActive

Official records

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0833-2019 FDA Class II initiated 10 Dec 2018
    • Terminated Z-0834-2019 FDA Class II initiated 10 Dec 2018

    Product mix up

Timeline

3 dated events

  1. Cleared FDA 510(k) K170613
  2. Recall initiated FDA recalls Z-0833-2019
  3. Recall initiated FDA recalls Z-0834-2019

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  • Withdrawn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
JWH
FDA applicant
Signature Orthopaedics Pty, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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