# K952236: Isola System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Jan 22, 1996 after 255 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.
702 later devices descend from it; 5 cite it directly.
1 of 703 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
- K981714: Timx Low Back System Titanium MX Rod Based Low Back System (1998), 597 descendants of its own
- K010576: Monarch Spine System (2001), 596 descendants of its own
- K024348: Monarch Spine System (2003), 578 descendants of its own
- K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod (2002), 496 descendants of its own
- K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods (2005), 495 descendants of its own

Source page: https://510kreport.com/device/K952236
Methodology: https://510kreport.com/methodology