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FDA 510(k)

APTUS Shoulder Proximal Humerus System, PentaLock 3.5

K-Number: K253916 · 2026-03-16

ApplicantMedartis AG
Decision Date2026-03-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253916. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Medartis AG. The 510(k) number is K253916.

When did APTUS Shoulder Proximal Humerus System, PentaLock 3.5 receive FDA 510(k) clearance?

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253916.

Who is the listed applicant for APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

The FDA 510(k) record lists Medartis AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

The FDA product code for APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is HRS.

Related Clinical Trials

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.

NCT07678034Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis SystemRECRUITING

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Related Devices (Code: HRS)

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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