# K160466: Response 5.5 Spine System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Mar 23, 2016 after 33 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw 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: 9 generations back to K990745 (1999). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150600: Response 5.5/6.0 Spine System, OrthoPediatrics Corp. (2015) Summary page 4.
- K130655: Response Spine System, OrthoPediatrics Corp. (2013) Summary page 4.

## Most influential descendants
- K162576: FORTEZZA Spinal Stabilization System (2016), 0 descendants of its own

## Indications for use
The Response 5.5 Spine System is intended for immobilization and stabilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K160466
Methodology: https://510kreport.com/methodology