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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 a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2026-03-16 under approval 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. It is manufactured by Medartis AG. The 510(k) number is K253916.

When was APTUS Shoulder Proximal Humerus System, PentaLock 3.5 approved by the FDA?

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

What company makes APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is manufactured by Medartis AG.

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.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Medartis AG

K172170APTUS(R) Wrist 2.5 System K161861APTUS® Coronoid 2.0 K181009APTUS CMC-I Fusion Plate System K181425APTUS® Proximal Humerus System K192297APTUS Wrist Arthrodesis Plates K191848APTUS Wrist Spanning Plates 2.5

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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