# K111232: Gap Endo-Exo Medullary System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Jan 26, 2012 after 269 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960642 (1996). 9 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K041393: Fassier-Duval Telscopic IM System, Pega Medical, Inc. (2004) Summary page 2.
- K020885: Fassire-Duval Telescopic IM System, Pega Medical, Inc. (2003) Summary page 2.
- K070843: Synthes Adolescent Lateral Entry Femoral Nail System, Synthes (Usa) (2007) Summary page 2.
- K993956: Titanium Pediatric Femoral Nail, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K160545: Gap Endo-Exo Medullary System (2016), 6 descendants of its own
- 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

## Recalls of this device
- Feb 20, 2015 · Class II · Z-1362-2015: Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) 

## 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 Endlo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions: * Diaphyseal facture of the femur, tibia and humerus * Fractures of the femoral neck * Subtrochanteric, intertrochanteric and combination fractures * Correction of deformities (01, Coxa vara, Coxa valga)> " Nonunions and malunions

Source page: https://510kreport.com/device/K111232
Methodology: https://510kreport.com/methodology