# K944756: Isola Open and Closed Screws

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: May 30, 1995 after 246 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
491 later devices descend from it; 2 cite it directly.
1 of 492 devices in its family (counting itself) has 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
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own
- K063156: Modification to Expedium Spine System (2006), 424 descendants of its own
- K063741: Expedium Spine System (2007), 398 descendants of its own
- K080313: Modification to Expedium Spine System (2008), 397 descendants of its own
- K063772: Expedium Spine System (2007), 264 descendants of its own

Source page: https://510kreport.com/device/K944756
Methodology: https://510kreport.com/methodology