510(k) · Cleared
ClearedCervical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 11, 2024 as substantially equivalent to K152282 (Life Spine, Inc., 2015) and 2 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Dec 11, 2024
- Review
- 42 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K926453 (1993). 45 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 6 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 5 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 4 generations backK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
- 3 generations backK113329 K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
- 2 generations backK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
- 1 generation backK152282 Cam Lock Plating SystemLife Spine, Inc. · 2015
- This deviceK243369 Cervical Plating SystemLife Spine, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −5 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −4 | K063544 | Modification to Pyrenees Cervical Plate System | K2m, Inc. | 2007 | — |
| −3 | K113329 | K2M, Pyrenees Cervical Plate System | K2m, Inc. | 2012 | — |
| −2 | K130202 | Iris Anterior Cervical Plate | Life Spine, Inc. | 2013 | — |
| −1 | K152282 | Cam Lock Plating System | Life Spine, Inc. | 2015 | — |
| 0 (this device) | K243369 | Cervical Plating System | Life Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K152282 | Cam Lock Plating SystemSummary page 5…tervertebral body fixation orthosis Classification: KWQ, CFR 888.3060, Class II Primary Predicate: Life Spine GRUVE Anterior Cervical Plating System K152282 Additional Predicate: Life Spine Neo-UL K103423 Choice Spine, Inc. Boomerang ACPS K190227 De… | 2015 |
| * | K103423 | Mis Anterior Cervical Plating SystemSummary page 5…KWQ, CFR 888.3060, Class II Primary Predicate: Life Spine GRUVE Anterior Cervical Plating System K152282 Additional Predicate: Life Spine Neo-UL K103423 Choice Spine, Inc. Boomerang ACPS K190227 Device Description: The Life Spine Cervical Plating Syst… | 2011 |
| * | K190227 | Boomerang™ Anterior Cervical Plate SystemSummary page 5…e Spine GRUVE Anterior Cervical Plating System K152282 Additional Predicate: Life Spine Neo-UL K103423 Choice Spine, Inc. Boomerang ACPS K190227 Device Description: The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated i… | 2019 |
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?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 7 of the 45 ancestors have a recall of any class.
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. 2024, this device’s year, is highlighted.
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 Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.)…
Read the full statement (135 words)
The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine.
The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243369: Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243369
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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