Zimmer, Inc. · Class II · Cleared Mar 12, 2026
| K-number | K253566 |
| Device name | Affixus Retrograde Femoral Nailing System |
| Applicant | Zimmer, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Affixus Retrograde Femoral Nailing System is an intramedullary fixation rod designed to treat a wide range of femoral fractures, including simple and compound shaft fractures, segmental fractures, supracondylar fractures, pathological fractures, and periprosthetic fractures. All nails are made of type II anodized Ti-6Al-4V and support flexible locking options for various intraoperative approaches.
The device has identical materials to the primary predicate device implants (type II anodized Ti-6Al-4V) and similar design features including packaging and sterilization methods. Minor differences in implant geometry do not affect safety or effectiveness, as supported by non-clinical testing.
Engineering analysis evaluating nail static strength/stiffness, static torsional stiffness, and bending fatigue strength. MR compatibility evaluation performed per ASTM F2182, ASTM F2052, ASTM F2119, and ASTM F2213.
View the full FDA submission: accessdata.fda.gov