# K070631: Device Modification to Radius Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Jul 13, 2007 after 128 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: 4 generations back to K984251 (1999). 16 ancestors in all.
201 later devices descend from it; 2 cite it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 2.
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 2.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 2.
- K031893: Xia Spinal System and Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 2.
- K052181: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 2.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K060631: Biograph 64 and Biograph 40, Siemens Medical Solutions USA, Inc. (2006). Our reading of the summary gave K060631, FDA’s number for Biograph 64 and Biograph 40 (Siemens Medical Solutions USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Spine Xia® Spinal System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own
- 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

## Indications for use
The RadiusTM 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 RadiusTM 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 RadiusTM Spinal System can also be linked to the Xia® Titanium Spinal System via the 05.5 mm to 06.0 mm Radius T rod-to-rod connector

Source page: https://510kreport.com/device/K070631
Methodology: https://510kreport.com/methodology