510(k) · Cleared
ClearedPrecision Surgery Limited Variable and Fixed Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Surgery Limited · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 12, 2004 after a 156-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Feb 12, 2004
- Review
- 156 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK032815 Precision Surgery Limited Variable and Fixed Cervical Plate SystemPrecision Surgery Limited · 2004
- Descendant · cites it directly · 1 of its ownK141332 Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine · 2015
- Descendant · 2 generations on · 0 of its ownK200301 UNiTi ACDF Implant SystemPressio, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK103819 PSL Anterior Cervical Plate SystemPrecision Surgery, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK103838 Fixed Variable & Corpectomy Cervical Plate SystemPrecision Surgery, Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K141332Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine · 2015 · cites it directly1descendant
- K200301UNiTi ACDF Implant SystemPressio, Inc. · 2021 · 2 generations on0descendants
- K103819PSL Anterior Cervical Plate SystemPrecision Surgery, Ltd. · 2011 · cites it directly0descendants
- K103838Fixed Variable & Corpectomy Cervical Plate SystemPrecision Surgery, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032815 | Precision Surgery Limited Variable and Fixed Cervical Plate System | Precision Surgery Limited | 2004 | — |
| +1 | K141332 | Captiva Spine SmartLOX Cervical Plate System | Captiva Spine | 2015 | — |
| +2 | K200301 | UNiTi ACDF Implant System | Pressio, Inc. | 2021 | — |
| +1 | K103819 | PSL Anterior Cervical Plate System | Precision Surgery, Ltd. | 2011 | — |
| +1 | K103838 | Fixed Variable & Corpectomy Cervical Plate System | Precision Surgery, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 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? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K141332 (Captiva Spine, 2015) has gone furthest, with 1 descendant 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 Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma…
Read the full statement (107 words)
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Variable and Fixed Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032815 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032815: Precision Surgery Limited Variable and Fixed Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032815
Report an extraction error
Are you the manufacturer?
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