Zimmer Switzerland Manufacturing GmbH · Class II · Cleared Dec 12, 2025
| K-number | K253749 |
| Device name | Affixus® Natural Nail® Proximal Humeral System |
| Applicant | Zimmer Switzerland Manufacturing GmbH |
| Product code | HSB |
| Device class | Class II |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Affixus Natural Nail Proximal Humeral System is an intramedullary nail designed for temporary internal fixation and stabilization of humeral fractures or osteotomies. It is indicated for proximal fractures, diaphyseal fractures, open and closed fractures, comminuted fractures, nonunions, malunions, and pathologic fractures of the humerus.
The subject device updates the CoreLock interface by changing the engagement mechanism from a tooth profile in the predicate to a multiple thread pitch design. This modification preserves friction fit mechanics while adding enhanced form-fit interaction for improved locking performance. The nails are made of Titanium alloy (Protasul-64WF) and C.P. Titanium, matching the predicate materials.
Verification testing included mechanical integrity and engagement strength evaluations using well-established, standardized methods. Testing followed ISO 5832-3/ASTM F136 and ISO 5832-2/ASTM F67 for titanium alloy materials. Testing was compared to the predicate device.
The subject device maintains the same fundamental technological characteristics, intended use, and indications as the predicate (K231114). The CoreLock interface modification does not introduce different questions of safety or effectiveness, and verification and performance testing demonstrate that the modified interface meets all performance requirements. The subject device is at least as safe and effective as the predicate device.
View the full FDA submission: accessdata.fda.gov