# K945500: Wells Johnson Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Wells Johnson Co.
- Decided: Sep 21, 1995 after 316 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960297: Mandibular Bone Distractor II (1996), 23 descendants of its own
- K964649: Vazquez Diner Intraoral Distraction Device (1997), 17 descendants of its own
- K972166: Guerrero - Bell Distractor (1997), 11 descendants of its own
- K972154: Cohen Distractor (1997), 8 descendants of its own
- K994154: Mod Line of Molina Distractors, 51-600 Series (2000), 7 descendants of its own

Source page: https://510kreport.com/device/K945500
Methodology: https://510kreport.com/methodology