# K020134: Spiral Radius 90-D Rodding System

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Apr 15, 2002 after 90 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970635 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970635: Titanium Spinal Rod System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 2.
- (no number) Spinal Concepts BacFix End-to-End Connector: named in the summary without a submission number
- (no number) Spiral Radius 90-D Rodding System Multi-Angle Screw/Rod construct: named in the summary without a submission number

## Indications for use
When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and 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. When used as a nonpedicle, posterior system consisting of hooks, crosslinks, and sacral/iliac screws, the levels of attachment are the lumbar, thoracic, and cervical spine and the sacrum and ilium. 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. When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at 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 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 or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.

Source page: https://510kreport.com/device/K020134
Methodology: https://510kreport.com/methodology