# K133904: CD Horizon Spinal System Growth Rod Set

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA
- Decided: Feb 25, 2014 after 67 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: 4 generations back to K013962 (2002). 6 ancestors in all.
43 later devices descend from it; 9 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121764: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2012) Summary page 6.
- (no number) Harrington Spinal Rod System: named in the summary without a submission number

## Most influential descendants
- K140750: Shilla Growth Guidance System (2014), 27 descendants of its own
- K150200: CD HORIZON Growth Rod Conversion Set (2015), 24 descendants of its own
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K142114: Xia® Growth Rod Conversion Set (2014), 13 descendants of its own

## Indications for use
The CD HORIZON® Growth Rod Conversion Set is indicated in 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 CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

Source page: https://510kreport.com/device/K133904
Methodology: https://510kreport.com/methodology