# K041393: Fassier-Duval Telscopic IM System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Aug 17, 2004 after 85 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960642 (1996). 5 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 20 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 2.

## Most influential descendants
- K111232: Gap Endo-Exo Medullary System (2012), 7 descendants of its own
- K160545: Gap Endo-Exo Medullary System (2016), 6 descendants of its own
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own
- K192710: The Simple Locking Intramedullary (Slim) System (2020), 5 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Recalls of this device
- Jul 4, 2024 · Class II · Z-2941-2024: During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
- Apr 10, 2015 · Class II · Z-1546-2015: The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument
- Mar 5, 2014 · Class II · Z-1472-2014: The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
- Feb 7, 2014 · Class II · Z-1448-2014: The Male Components in this lot are made of material with lower strength than manufacturing specifications.
- Jan 29, 2010 · Not classified · Z-1494-2011: Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitte

## 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/K041393
Methodology: https://510kreport.com/methodology