510(k) K251771

Cambridge Partial Knee by Signature Orthopaedics Pty, Ltd. — Product Code HSX

K251771 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Cambridge Partial Knee". The FDA issued a decision of Substantially Equivalent on December 16, 2025. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.