510(k) · Cleared
ClearedSurgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod 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 Oct 26, 1998 as substantially equivalent to K974213 (United States Surgical, A Division of Tyco Healthc, 1998) and 2 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Oct 26, 1998
- Review
- 45 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K970635 (1997). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 1 generation backK974213 Aurora Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- This deviceK983197 Surgical Dynamics Rodding System (Previously Known as the Aurora…United States Surgical, A Division of Tyco Healthc · 1998
- Descendant · cites it directly · 2 of its ownK992784 Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999
- Descendant · 2 generations on · 1 of its ownK000009 Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000
- Descendant · 2 generations on · 0 of its ownK012273 Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001
Most influential descendants
Showing 3 of 3 · See all- K992784Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999 · cites it directly2descendants
- K000009Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000 · 2 generations on1descendant
- K012273Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970635 | Titanium Spinal Rod System | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −1 | K974213 | Aurora Titanium Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| 0 (this device) | K983197 | Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium… | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +1 | K992784 | Next Generation Rodding System | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +2 | K000009 | Spiral Radius Rodding System | United States Surgical, A Division of Tyco Healthc | 2000 | — |
| +2 | K012273 | Spiral Radius 90-D SST System | United States Surgical, A Division of Tyco Healthc | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K970635 | FDA’s K970635 is Titanium Spinal Rod System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
| * | K974213 | Aurora Titanium Spinal Rod SystemSummary page 1…em Titanium Spinal Rod System PROPRIETARY NAME: Surgical Dynamics Rodding System PREDICATE DEVICES: USSC's Surgical Dynamics Rodding System - KS70635, INTENDED USE: K974213, K974734, K980862 (originally submitted as the Aurora Titanium Spinal Rod System) The components of the Surgical Dynamics Roddin… | 1998 |
| * | K974734 | Aurora Titanium Spinal Rod SystemSummary page 1…ium Spinal Rod System PROPRIETARY NAME: Surgical Dynamics Rodding System PREDICATE DEVICES: USSC's Surgical Dynamics Rodding System - KS70635, INTENDED USE: K974213, K974734, K980862 (originally submitted as the Aurora Titanium Spinal Rod System) The components of the Surgical Dynamics Rodding System… | 1998 |
| * | K980862 | Titanium Spinal Rod SystemSummary page 1…l Rod System PROPRIETARY NAME: Surgical Dynamics Rodding System PREDICATE DEVICES: USSC's Surgical Dynamics Rodding System - KS70635, INTENDED USE: K974213, K974734, K980862 (originally submitted as the Aurora Titanium Spinal Rod System) The components of the Surgical Dynamics Rodding System are indic… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992784 | Next Generation Rodding System | 1999 | 2 |
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?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K992784 (United States Surgical, A Division of Tyco Healthc, 1999) has gone furthest, with 2 descendants of its own.
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?
The components of the Surgical Dynamics Rodding System are indicated for spinal fixation. When used as an anterolateral/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…
Read the full statement (351 words)
The components of the Surgical Dynamics Rodding System are indicated for spinal fixation.
When used as an anterolateral/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 (pseudarthrosis).
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacralfiliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the 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 degeneration 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 (pseudarthrosis).
When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the 1L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (¢) 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 a solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS 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: degeneralive spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scaliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
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/K983197 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983197: Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983197
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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