# K143355: The Simple Locking IntraMedullary (SLIM) System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Jul 10, 2015 after 228 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: 5 generations back to K960642 (1996). 14 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 4.
- K082375: Orthopediatrics Pediflex Flexible Nail System, OrthoPediatrics Corp. (2008) Summary page 4.
- K041393: Fassier-Duval Telscopic IM System, Pega Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- K192710: The Simple Locking Intramedullary (Slim) System (2020), 5 descendants of its own
- 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

## Recalls of this device
- May 29, 2019 · Class II · Z-2278-2019: Handle could jam with the Driver due to the detachment of an internal Connector Ring.

## Indications for use
The 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 the femur, tibia, humerus, ulna and fibula of the pediatric population (child and adolescent), and patients with small intramedullary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.

Source page: https://510kreport.com/device/K143355
Methodology: https://510kreport.com/methodology