# K161028: K2M Growing Spine System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jul 22, 2016 after 101 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: 18 generations back to K853033 (1985). 321 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 325 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.
- K140750: Shilla Growth Guidance System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 5.
- K120099: Range Spinal System (Mesa and Denali), K2m, Inc. (2012) Summary page 5.
- K121630: Range Spinal System, K2m, Inc. (2012) Summary page 5.
- K141873: Range/Mesa/Denali Spinal System, K2m, Inc. (2014) Summary page 5.
- K141509: Isola and Expedium Growing Spine Systems, Medos Sarl (2014) Summary page 5.
- K142114: Xia® Growth Rod Conversion Set, Stryker Corporation (2014) Summary page 5.
- K781443: Harrington Spine Instrumentation, Orthopedic Equipment Co., Inc. (1978) Summary page 5.
- K781448: Harrington Hook Clamp, Orthopedic Equipment Co., Inc. (1978) Summary page 5.
- K781449: Harrington Spinal Elevator, Orthopedic Equipment Co., Inc. (1978) Summary page 5.

## Most influential descendants
- K181068: CREO® Stabilization System, REVERE® Stabilization System (2018), 2 descendants 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
- K213196: MARVEL™ Growing Rods (2022), 0 descendants of its own

## Indications for use
The K2M Growing Spine System implants are 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 Growth Guidance implants may be used with any cleared K2M rod construct ranging in diameter 4.5mm to 6.35mm. The Growth Rod Conversion implants may be used with 4.5mm and 5.5mm rod constructs. The K2M Growing Spine System is not intended to be used in conjunction with staples.

Source page: https://510kreport.com/device/K161028
Methodology: https://510kreport.com/methodology