# K211292: Fassier-Duval Telescopic IM System

- Pathway: 510(k) (Special)
- Applicant: Pega Medical, Inc.
- Decided: May 26, 2021 after 28 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: 4 generations back to K960642 (1996). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K241983: Fassier-Duval Telescoping IM System (2025), 0 descendants of its own
- K232648: RODEO Telescopic Nail (2024), 0 descendants of its own

## 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 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/K211292
Methodology: https://510kreport.com/methodology