# K220659: AUTOBAHN (R) EVO Femoral Nails

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Sep 9, 2022 after 186 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: 7 generations back to K951740 (1995). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 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 4.
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm, Synthes (USA) Products, LLC (2020) Summary page 4.
- K172157: DePuy Synthes Femoral Recon Nail System, Synthes (USA) Products, LLC (2017) Summary page 4.

## Most influential descendants
- K261043: AUTOBAHN™ Nailing System (2026), 0 descendants of its own

## Indications for use
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/K220659
Methodology: https://510kreport.com/methodology