Active-X Total Knee System

by Signature Orthopaedics Pty Ltd

510(k) K160159

Active-X Total Knee System is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K160159 on 6 Sep 2016, active as of 22 Oct 2026.

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

510(k) K160159↗

FDA record

Trust

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK160159	Date6 Sep 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K160159

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K160159
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

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