510(k) · Cleared
ClearedSpiral Radius 90-D Rodding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 15, 2002 as substantially equivalent to K970635 (Smith & Nephew, Inc., Orthopaedic Div., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 15, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970635 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
- This deviceK020134 Spiral Radius 90-D Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970635 | Titanium Spinal Rod System | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| 0 (this device) | K020134 | Spiral Radius 90-D Rodding System | United States Surgical, A Division of Tyco Healthc | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970635 | Titanium Spinal Rod SystemSummary page 2…LENCE* The components added to the Spiral Radius 90-D Rodding System were claimed to be substantially equivalent* to components of the Surgical Dynamics Rodding System (K970635). The Spiral Radius 90- D Rodding System Rod-to-Rod Connector was claimed to be substantially equivalent* to the Spinal Concepts… | 1997 |
| * | — | Spinal Concepts BacFix End-to-End Connector Named without a submission number | |
| * | — | Spiral Radius 90-D Rodding System Multi-Angle Screw/Rod construct Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K970635.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (329 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020134: Spiral Radius 90-D Rodding System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020134
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026