# K101144: Modification to:Radius Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Jul 8, 2010 after 76 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: 6 generations back to K950697 (1995). 34 ancestors in all.
90 later devices descend from it; 6 cite it directly.
0 of 125 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.
- K082608: Radius Spinal System, Vitallium Rod #486613601, Stryker Spine (2008) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.

## Most influential descendants
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal (2013), 84 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K111478: Stryker Spine Power Adaptor (Accessory Instrument) (2011), 34 descendants of its own
- K120434: Power Adaptor Instrument Accessory (2012), 32 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own

## Indications for use
The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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. 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/K101144
Methodology: https://510kreport.com/methodology