# K261043: AUTOBAHN™ Nailing System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Apr 24, 2026 after 24 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K970097 (1997). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171108: AUTOBAHN Nailing System, Globus Medical, Inc. (2017) Summary page 5.
- K200869: Gamma3 System, Stryker Trauma GmbH (2020) Summary page 5.
- K220659: AUTOBAHN (R) EVO Femoral Nails, Globus Medical, Inc. (2022) Summary page 5.

## Indications for use
The AUTOBAHN™ Trochanteric Nail is indicated for treatment of fractures in adults and adolescents (12-21 years of age) in which the growth plates have fused for the following indications: basal neck fractures, fixation of stable and unstable intertrochanteric, pertrochanteric, and subtrochanteric fractures (including osteoporotic and osteopenic bone), pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, combinations of pertrochanteric, intertrochanteric, basal neck fractures, long subtrochanteric fractures, tumor resections, fractures resulting from trauma, nonunions, malunions, and revision procedures. AUTOBAHN™ EVO Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN™ EVO Antegrade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

Source page: https://510kreport.com/device/K261043
Methodology: https://510kreport.com/methodology