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FDA 510(k)

Affixus® Natural Nail® Proximal Humeral System

K-Number: K253749 · 2025-12-12

ApplicantZimmer Switzerland Manufacturing GmbH
Decision Date2025-12-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Affixus® Natural Nail® Proximal Humeral System is a medical device manufactured by Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2025-12-12 under approval number K253749. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affixus® Natural Nail® Proximal Humeral System?

Affixus® Natural Nail® Proximal Humeral System is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K253749.

When was Affixus® Natural Nail® Proximal Humeral System approved by the FDA?

Affixus® Natural Nail® Proximal Humeral System received FDA 510(k) clearance on 2025-12-12, under approval number K253749.

What company makes Affixus® Natural Nail® Proximal Humeral System?

Affixus® Natural Nail® Proximal Humeral System is manufactured by Zimmer Switzerland Manufacturing GmbH.

What is the FDA product code for Affixus® Natural Nail® Proximal Humeral System?

The FDA product code for Affixus® Natural Nail® Proximal Humeral System is HSB.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression RECRUITING NCT07573059 Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients RECRUITING NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Zimmer Switzerland Manufacturing GmbH

K212129Persona® Personalized Knee System K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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