# K922504: Isola (R) Tandem Connector

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: May 18, 1993 after 356 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K141509: Isola and Expedium Growing Spine Systems (2014), 6 descendants of its own
- K161028: K2M Growing Spine System (2016), 3 descendants of its own
- K181068: CREO® Stabilization System, REVERE® Stabilization System (2018), 2 descendants of its own
- K142587: Vertical Expandable Prosthetic Titanium Rib (2014), 1 descendant of its own
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K922504
Methodology: https://510kreport.com/methodology