# K192710: The Simple Locking Intramedullary (Slim) System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Jun 24, 2020 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: 6 generations back to K960642 (1996). 15 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143355: The Simple Locking IntraMedullary (SLIM) System, Pega Medical, Inc. (2015) Summary page 5.

## Most influential descendants
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants 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
- K250197: Estremo Fibular Nail (2025), 0 descendants of its own
- K241983: Fassier-Duval Telescoping IM System (2025), 0 descendants of its own

## Indications for use
The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes: Femur and tibia in the pediatric population (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Humerus, ulna, fibula in all patient populations

Source page: https://510kreport.com/device/K192710
Methodology: https://510kreport.com/methodology