Cleared Traditional

Cambridge Partial Knee

K251771 · Signature Orthopaedics Pty, Ltd. · Orthopedic

Dec 2025

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K251771 is an FDA 510(k) clearance for the Cambridge Partial Knee, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on December 16, 2025, 189 days after receiving the submission on June 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K251771 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2025
Decision Date	December 16, 2025
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520