# K082608: Radius Spinal System, Vitallium Rod #486613601

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Oct 7, 2008 after 29 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: 5 generations back to K950697 (1995). 33 ancestors in all.
200 later devices descend from it; 5 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070631: Device Modification to Radius Spinal System, Stryker Spine (2007) Summary page 1.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.

## Most influential descendants
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod (2009), 169 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K092631: Mantis Redux Spinal System (2009), 110 descendants of its own
- K102235: Mantis Spinal System & Mantis Redux Spinal System (2010), 109 descendants of its own
- K101144: Modification to:Radius Spinal System (2010), 90 descendants of its own

## Indications for use
The Radius® 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); tunmor; pseudoarthrosis; and failed previous fusion. The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the 05.5 mm to 06.0 mm Radius® rod-to-rod connector.

Source page: https://510kreport.com/device/K082608
Methodology: https://510kreport.com/methodology