# K241983: Fassier-Duval Telescoping IM System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopediatrics Canada Ulc Dba Pega Medical
- Decided: Feb 21, 2025 after 228 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: 7 generations back to K960642 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211292: Fassier-Duval Telescopic IM System, Pega Medical, Inc. (2021) Summary page 5.
- K041393: Fassier-Duval Telscopic IM System, Pega Medical, Inc. (2004) Summary page 5.
- K020885: Fassire-Duval Telescopic IM System, Pega Medical, Inc. (2003) Summary page 5.
- K192710: The Simple Locking Intramedullary (Slim) System, Pega Medical, Inc. (2020) Summary page 5.

## Indications for use
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta and other pediatric bone diseases without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

Source page: https://510kreport.com/device/K241983
Methodology: https://510kreport.com/methodology