# K193100: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Mar 24, 2020 after 137 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: 10 generations back to K040583 (2004). 114 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181390: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System, OrthoPediatrics Corp. (2018) Summary page 4.
- K141494: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K150600: Response 5.5/6.0 Spine System, OrthoPediatrics Corp. (2015) Summary page 4.

## Most influential descendants
- K201420: Republic Spine Dark Star Spinal System (2021), 2 descendants of its own
- K223096: Dark Star Deformity Pedicle Screw System (2023), 1 descendant of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own
- K222105: RESPONSE 5.5/6.0 Cannulated Screw System (2023), 0 descendants of its own

## Indications for use
The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems are intended for immobilization and stabilization of the posterior, non-cervical 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 4.5/5.0 and 5.5/6.0 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The Response 4.5/5.0 and 5.5/6.0 Spine Systems are 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/K193100
Methodology: https://510kreport.com/methodology