# K981423: Autogenesis Automator 2000 Model Number SC2000

- Pathway: 510(k) (Special)
- Applicant: Autogenesis, Inc.
- Decided: May 20, 1998 after 30 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
Longest line of descent: 1 generation back to K905514 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905514: Autogenesis (TM) Automator, Advanced Biosearch Assn. (1991) Summary page 1.

## Most influential descendants
- K013818: Autogenesis Automator, Model M1000 (2001), 0 descendants of its own

## Indications for use
The Autogenesis™ Automator™2000, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™2000 may replace the CF Automator™ or manual distraction and compression devices where they are traditionally applied. Indications for such use include the following: the correction of bony or soft tissue deformities, limb lengthening by epiphayseal and metaphyseal distraction, bone thickening and/or lengthening of amputated stumps, fracture fixation (open or closed), pseudoarthrosis or non-union of long bones, correction of segmental bony or soft tissue defects.

Source page: https://510kreport.com/device/K981423
Methodology: https://510kreport.com/methodology