# K172438: ARBOR External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 12, 2018 after 154 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861766 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe, Synthes (Usa) (2003) Summary page 4.
- K052605: External Fixation, Gexfix USA, Inc. (2005) Summary page 4.
- K160972: Gexfix External Fixation, Gexfix International Corp. (2016) Summary page 4.
- K093550: Mini Rail External Fixator System, Small Bone Innovations, Inc. (2010) Summary page 4.
- K122284: Hoffmann 3, Stryker Corp. (2012) Summary page 4.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 4.
- K040258: Synthes Medium External Fixation System-MR Safe, Synthes (Usa) (2004) Summary page 4.

## Indications for use
The ARBOR™ External Fixation System is indicated for use in construction of an external fixation frame for the treatment of pediatric and adult fractures and/or reconstruction of long bones, small bones (including metacarpal and metatarsal), and the pelvis. The ARBOR™ External Fixation System is intended for: • Stabilization of open or closed fractures with soft tissue injuries; • Polytrauma; • Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; • Arthrodesis and osteotomies with soft tissue problems; • Revision procedures where other devices have been unsuccessful including failures of total joints; • Neutralization of fractures stabilized with limited internal fixation; • Non-unions/septic non-unions; • Intraoperative reduction/stabilization tool to assist with indirect reduction; • Correction of deformity; and • Unilateral rectilinear bone segment transport or leg lengthening.

Source page: https://510kreport.com/device/K172438
Methodology: https://510kreport.com/methodology