510(k) · Cleared
ClearedTitanium Spinal Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc., Orthopaedic Div. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 14, 1997 after a 175-day review. The FDA summary names no predicate by number. 72 later devices descend from it.
- Decided
- Aug 14, 1997
- Review
- 175 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 6 citing it directly.
- This deviceK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
- Descendant · cites it directly · 62 of its ownK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- Descendant · 2 generations on · 61 of its ownK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- Descendant · 2 generations on · 56 of its ownK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- Descendant · 2 generations on · 49 of its ownK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- Descendant · 3 generations on · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004 · cites it directly62descendants
- K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005 · 2 generations on61descendants
- K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005 · 2 generations on56descendants
- K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007 · 2 generations on49descendants
- K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970635 | Titanium Spinal Rod System | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| +1 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| +2 | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| +2 | K051716 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| +2 | K071376 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2007 | — |
| +3 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (72)
See all 726 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033352 | Vertebron PSS Pedicle Screw System | 2004 | 62 |
| K980862 | Titanium Spinal Rod System | 1998 | 4 |
| K974734 | Aurora Titanium Spinal Rod System | 1998 | 4 |
| K974213 | Aurora Titanium Spinal Rod System | 1998 | 4 |
| K020134 | Spiral Radius 90-D Rodding System | 2002 | 0 |
| K980928 | Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System | 1998 | 0 |
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?
- Of its descendants, K033352 (Vertebron, Inc., 2004) has gone furthest, with 62 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The components of the Titanium Spinal Rod 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 and the anterior vertebral bodies of the cervical spine. Intended uses for this device include…
Read the full statement (375 words)
The components of the Titanium Spinal Rod 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 and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to 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, multi-operated back or revision of previous surgery.
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. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac 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), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended 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; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1.
The devices are for single use. Cementless or cement fixation is not applicable to this device. These devices have not been submitted to the FDA for different intended uses.
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/K970635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970635: Titanium Spinal Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970635
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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