# K062270: Radius Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Nov 22, 2006 after 107 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
460 later devices descend from it; 8 cite it directly.
1 of 461 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071373: Stryker Spine Xia Iii Spinal System (2007), 430 descendants of its own
- K083393: Xia 3 Spinal System (2009), 292 descendants of its own
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own
- K070631: Device Modification to Radius Spinal System (2007), 201 descendants of its own
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own

## Recalls of this device
- Jul 10, 2007 · Not classified · Z-1239-2007: Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod

## Indications for use
The RadiusTM Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K062270
Methodology: https://510kreport.com/methodology