Cleared Traditional

Longboard Revision Hip Stem

K243021 · Signature Orthopaedics Pty, Ltd. · Orthopedic

Aug 2025

Decision

314d

Days

Class 2

Risk

About This 510(k) Submission

K243021 is an FDA 510(k) clearance for the Longboard Revision Hip Stem, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on August 7, 2025, 314 days after receiving the submission on September 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K243021 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	August 07, 2025
Days to Decision	314 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353