# K130655: Response Spine System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: May 8, 2013 after 57 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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: 7 generations back to K990745 (1999). 52 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120291: OP Spine System, OrthoPediatrics Corp. (2012) Summary page 1.
- K121250: OP Spine System, OrthoPediatrics Corp. (2012) Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.

## Most influential descendants
- K150600: Response 5.5/6.0 Spine System (2015), 16 descendants of its own
- K181390: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System (2018), 13 descendants of its own
- K210539: CoreLink Midline Fixation System (2021), 4 descendants of its own
- K193100: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System (2020), 4 descendants of its own
- K241519: Invictus® Small Stature Spinal Fixation System (2024), 2 descendants of its own

## Indications for use
The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K130655
Methodology: https://510kreport.com/methodology