# K000009: Spiral Radius Rodding System

- Pathway: 510(k) (Abbreviated)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 10, 2000 after 67 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K970635 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992784: Next Generation Rodding System, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.

## Most influential descendants
- K012273: Spiral Radius 90-D SST System (2001), 0 descendants of its own

## Indications for use
The components of the Spiral Radius Rodding System are indicated for spinal fixation. When used as an ante rolateraI/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine-, and hook and sacralfiliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoiiosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K000009
Methodology: https://510kreport.com/methodology