# K171108: AUTOBAHN Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 29, 2017 after 259 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: 6 generations back to K951740 (1995). 39 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 5.
- K131365: T2 Tibial Nailing System, Stryker Trauma AG (2013) Summary page 5.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 5.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 5.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 5.
- K131548: Synthes Trochanteric Fixation Nail - Advanced System, Synthes (USA) Products, LLC (2014) Summary page 5.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 5.
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 5.
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 5.
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp, Stryker (2011) Summary page 5.

## Most influential descendants
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own
- K261043: AUTOBAHN™ Nailing System (2026), 0 descendants of its own

## Indications for use
The AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, malunions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, polytrauma and multiple fractures, reconstruction, following tumor resection and grafting, supracondylar fractures, and bone lengthening and shortening. 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, 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™ Antegrade/Retrograde 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.

Source page: https://510kreport.com/device/K171108
Methodology: https://510kreport.com/methodology