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FDA 510(k)

Cambridge Partial Knee

K-Number: K251771 · 2025-12-16

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-12-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cambridge Partial Knee is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under approval number K251771. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cambridge Partial Knee?

Cambridge Partial Knee is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K251771.

When was Cambridge Partial Knee approved by the FDA?

Cambridge Partial Knee received FDA 510(k) clearance on 2025-12-16, under approval number K251771.

What company makes Cambridge Partial Knee?

Cambridge Partial Knee is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Cambridge Partial Knee?

The FDA product code for Cambridge Partial Knee is HSX.

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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.

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