Fassire-Duval Telescopic Im System

• • Terminated Z-1546-2015 FDA Class II ·initiated 10 Apr 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, possibly leading to deformation, wear, and tip breakage.

• • Terminated Z-1472-2014 FDA Class II ·initiated 5 Mar 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.

• • Terminated Z-1448-2014 FDA Class II ·initiated 7 Feb 2014

  The Male Components in this lot are made of material with lower strength than manufacturing specifications.

• • Terminated Z-1494-2011 FDA Unclassified (pre-2012) ·initiated 29 Jan 2010

  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 submitted to large torsional loads higher than the normal forces required to introduce the male component.

510(k) Number

K020885 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• The Locking Pediatric Osteotomy Plate (LolliPOP) System

  Class II

  FDA 510(k) K170704 Active Cleared 8 Sep 2017

• The GIRO Growth Modulation System

  Class II

  FDA 510(k) K220190 Active Cleared 24 Oct 2022

• Free Gliding Slipped Capital Femoral Epiphysis Screw (SCFE)

  Class II

  FDA 510(k) K131591 Active Cleared 27 Nov 2013

• Gap Endo-Exo Medullary System

  Class II

  FDA 510(k) K160545 Active Cleared 23 Nov 2016

• The Simple Locking Intramedullary (Slim) System

  Class II

  FDA 510(k) K192710 Active Cleared 24 Jun 2020

• Y3 Proximal Femoral Plate System

  Class II

  FDA 510(k) K163003 Active Cleared 16 Mar 2017

See all devices from Pega Medical, Inc. →