# K141509: Isola and Expedium Growing Spine Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medos Sarl
- Decided: Aug 22, 2014 after 77 days
- Product code: PGM (Growing Rod System)
- 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
Longest line of descent: 5 generations back to K013962 (2002). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133904: CD Horizon Spinal System Growth Rod Set, Medtronic Sofamor Danek USA (2014) Summary page 5.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 5.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 5.
- K922504: Isola (R) Tandem Connector, Acromed Corp. (1993) Summary page 6.
- (no number) Harrington Spinal Rod System (Pre-Amendment): named in the summary without a submission number

## Most influential descendants
- 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
- K233105: RESPONSE™ Rib and Pelvic System (2024), 0 descendants of its own

## Indications for use
The ISOLA® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs. The EXPEDIUM® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM® Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.

Source page: https://510kreport.com/device/K141509
Methodology: https://510kreport.com/methodology