FDA 510(k)

Origin Cemented Hip Stem

K-Number: K243043 · 2025-05-02

ApplicantSignature Orthopaedics Pty, Ltd.

Decision Date2025-05-02

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Origin Cemented Hip Stem is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under approval number K243043. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Origin Cemented Hip Stem?

Origin Cemented Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243043.

When was Origin Cemented Hip Stem approved by the FDA?

Origin Cemented Hip Stem received FDA 510(k) clearance on 2025-05-02, under approval number K243043.

What company makes Origin Cemented Hip Stem?

Origin Cemented Hip Stem is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Origin Cemented Hip Stem?

The FDA product code for Origin Cemented Hip Stem is LZO.

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.