Cleared Special

Affixus® Natural Nail® Proximal Humeral System (K253749) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253749 · Zimmer Switzerland Manufacturing GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2025
Decision
17d
Days
Class 2
Risk

K253749 is an FDA 510(k) clearance for the Affixus® Natural Nail® Proximal Humeral System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on December 12, 2025 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer Switzerland Manufacturing GmbH devices

Submission Details

510(k) Number K253749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date December 12, 2025
Days to Decision 17 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 260
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K253749.
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