| K-number | K261043 |
| Device name | AUTOBAHN Nailing System |
| Applicant | Globus Medical, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The AUTOBAHN™ Nailing System is a family of intramedullary nails, screws, and washers for internal bone fixation. The AUTOBAHN™ Hip Fastener with Helical Hook Technology is a hip fixation fastener for use with the AUTOBAHN™ Trochanteric Nails in treating various hip and femoral fractures in adults and adolescents (12-21 years) with fused growth plates.
The subject device has similar technological characteristics to the predicate devices including overall design, intended use, material composition (titanium alloy), function, and range of sizes. The primary difference is the thread geometry: the subject device uses helical hook thread geometry compared to standard cancellous threads in the predicate device.
Cutout testing was conducted to demonstrate substantial equivalence. Insertion torque and static torsion testing were performed in accordance with ASTM F543.
The AUTOBAHN™ Nailing System implants are substantially equivalent to the predicate device based on similar technical characteristics, performance, and intended use. Despite the difference in thread geometry (helical hook versus standard cancellous), the devices share the same overall design, material, function, and clinical indications.
View the full FDA submission: accessdata.fda.gov