# K150600: Response 5.5/6.0 Spine System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: May 22, 2015 after 73 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K990745 (1999). 53 ancestors in all.
16 later devices descend from it; 3 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)
- K130655: Response Spine System, OrthoPediatrics Corp. (2013) Summary page 4.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K120291: OP Spine System, OrthoPediatrics Corp. (2012) Summary page 4.

## Most influential descendants
- 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
- K221776: NextGen Pedicle Screw System (2022), 2 descendants of its own

## Recalls of this device
- Jul 6, 2020 · Class II · Z-2742-2020: Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
- Aug 3, 2017 · Class II · Z-0597-2018: The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
- Nov 10, 2015 · Class II · Z-0622-2016: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw

## Indications for use
The Response 5.5/6.0 Spine System is 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 5.5/6.0 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5/6.0 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/K150600
Methodology: https://510kreport.com/methodology