Encore Hip Stem

by Signature Orthopaedics Pty Ltd

510(k) K211505

Encore Hip Stem is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K211505 on 24 Sep 2021, 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) K211505↗

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	NumberK211505	Date24 Sep 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K211505

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K211505
FDA product code: MEH
FDA applicant: Signature Orthopaedics Pty, Ltd.

Device class: Class II
Regulation: 21 CFR Part 888.3353
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →