510(k) · Cleared
ClearedModification to Highgate Curved Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Highgate Orthopaedics · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 22, 2003 after a 294-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 22, 2003
- Review
- 294 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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- #2 Held for the reportin the report
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What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Highgate Lateral Curved Rods 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.
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 Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as…
Read the full statement (112 words)
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023983: Modification to Highgate Curved 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/K023983
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026