# K031219: Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: May 28, 2003 after 41 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831576 (1983). 4 ancestors in all.
30 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor), Orthodyne, Inc. (2001)

## Most influential descendants
- K101997: Ellipse Intramedullary Limb Lengthening System (2011), 29 descendants of its own
- K131677: Precice Intramedullary Limb Lengthening System (2013), 21 descendants of its own
- K133289: Precice Intramedullary Limb Lengthening System (2013), 19 descendants of its own
- K113219: Ellipse Precice Intramedullary Limb Lengthening System (2012), 15 descendants of its own
- K131490: Ellipse Precice Intramedullary Limb Lengthening System (2014), 14 descendants of its own

## Recalls of this device
- Aug 6, 2012 · Class II · Z-0895-2013: There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) le

## Indications for use
The ISKD is indicated for limb lengthening of the tibia and femur.

Source page: https://510kreport.com/device/K031219
Methodology: https://510kreport.com/methodology