510(k) · Cleared
ClearedMis Anterior Cervical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 1, 2011 as substantially equivalent to K073275 (Nuvasive, Inc., 2008) and 1 other predicate after a 191-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jun 1, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002592 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
- 2 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
- 1 generation backK070285 Life Spine Anterior Cervical Plate SystemLife Spine · 2007
- This deviceK103423 Mis Anterior Cervical Plating SystemLife Spine · 2011
- Descendant · cites it directly · 0 of its ownK243369 Cervical Plating SystemLife Spine, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243369Cervical Plating SystemLife Spine, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −2 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| −1 | K070285 | Life Spine Anterior Cervical Plate System | Life Spine | 2007 | — |
| 0 (this device) | K103423 | Mis Anterior Cervical Plating System | Life Spine | 2011 | — |
| +1 | K243369 | Cervical Plating System | Life Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K073275 | Nuvasive Helix Mini Acp SystemSummary page 1…Orthosis Class 11 Classification: KWQ Predicate Device: Nuvasive Helix-Mini ACP (K073275) NEO SL Anterior Cervical Plate (K070285) Device Description: The MIS Anterior Cervical Pl… | 2008 |
| * | K070285 | Life Spine Anterior Cervical Plate SystemSummary page 1…KWQ Predicate Device: Nuvasive Helix-Mini ACP (K073275) NEO SL Anterior Cervical Plate (K070285) Device Description: The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior f… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243369 | Cervical Plating System | 2024 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K243369 (Life Spine, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K073275.
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. 2011, 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 MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion 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 and/or scoliosis);
6. Tumors;
7. Pseudarthrosis;
8. Failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103423: Mis Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103423
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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