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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 the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K251771.

When did Cambridge Partial Knee receive FDA 510(k) clearance?

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

Who is the listed applicant for Cambridge Partial Knee?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cambridge Partial Knee?

The FDA product code for Cambridge Partial Knee is HSX.

Other records listing Signature Orthopaedics Pty, Ltd. as applicant

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Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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