# K160545: Gap Endo-Exo Medullary System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Nov 23, 2016 after 271 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: 5 generations back to K960642 (1996). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111232: Gap Endo-Exo Medullary System, Pega Medical, Inc. (2012) Summary page 4.
- K041393: Fassier-Duval Telscopic IM System, Pega Medical, Inc. (2004) Summary page 4.
- K020885: Fassire-Duval Telescopic IM System, Pega Medical, Inc. (2003) Summary page 4.

## Most influential descendants
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (2025), 1 descendant of its own
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own

## Indications for use
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions: * Diaphyseal fracture of the femur, tibia and humerus * Fractures of the femoral neck * Subtrochanteric, intertrochanteric and combination fractures * Correction of deformities (OI, Coxa vara, Coxa valga) * Nonunions and malunions

Source page: https://510kreport.com/device/K160545
Methodology: https://510kreport.com/methodology