# K831576: Orthofix

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Jun 8, 1983 after 23 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
103 later devices descend from it; 6 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955848: Orthofix Modulsystem (1996), 95 descendants of its own
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor) (2001), 35 descendants of its own
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K031219: Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) (2003), 30 descendants of its own
- K101997: Ellipse Intramedullary Limb Lengthening System (2011), 29 descendants of its own

Source page: https://510kreport.com/device/K831576
Methodology: https://510kreport.com/methodology