# K020885: Fassire-Duval Telescopic IM System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Feb 6, 2003 after 325 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960642 (1996). 4 ancestors in all.
15 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)
- K980854: Retrograde Pediatric Nail, Encore Orthopedics, Inc. (1998) Summary page 2.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 2.
- K813371: Grosse and Kempf Locking Nail Sys., Howmedica Corp. (1982) Summary page 2.
- (no number) Dubow-Bailey Intramedullary Nail: named in the summary without a submission number

## Most influential descendants
- K041393: Fassier-Duval Telscopic IM System (2004), 14 descendants of its own
- 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

## Recalls of this device
- 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 lengtheninghhortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

Source page: https://510kreport.com/device/K020885
Methodology: https://510kreport.com/methodology