510(k) · Cleared
ClearedModification to Life Spine Neo Anterior Cervical Plate 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 Oct 19, 2006 as substantially equivalent to K040844 (Life Spine, LLC, 2004) after a 29-day review. Its family tree reaches back 2 generations to 2000. 17 later devices descend from it.
- Decided
- Oct 19, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002592 (2000). 3 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
- 1 generation backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
- This deviceK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
- Descendant · cites it directly · 16 of its ownK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
- Descendant · 2 generations on · 15 of its ownK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
- Descendant · 3 generations on · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
- Descendant · 4 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010 · cites it directly16descendants
- K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · 2 generations on15descendants
- K153526Pyrenees Cervical Plate SystemK2m · 2016 · 3 generations on6descendants
- K140234Aspiron Acp SystemU&I Corp. · 2014 · 3 generations on6descendants
- K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −1 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| 0 (this device) | K062831 | Modification to Life Spine Neo Anterior Cervical Plate System | Life Spine | 2006 | — |
| +1 | K093776 | Indus Anterior Cervical Plate System | Spinefrontier, Inc. | 2010 | — |
| +2 | K121060 | Spine Frontier Indus Acp System | Spinefrontier, Inc. | 2012 | 6 |
| +3 | K153526 | Pyrenees Cervical Plate System | K2m | 2016 | — |
| +3 | K140234 | Aspiron Acp System | U&I Corp. | 2014 | — |
| +4 | K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K040844 | Life Spine Neo Anterior Cervical Plate SystemSummary page 1…Class II Device Product Code: KWQ Predicate Device: NEOTm Anterior Cervical Plate System K040844 and other predicate devices Device Description: The NEOTm Anterior Ce… | 2004 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093776 | Indus Anterior Cervical Plate System | 2010 | 16 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093776 (Spinefrontier, Inc., 2010) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K040844.
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 NEOTM Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to TI during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma…
Read the full statement (115 words)
The NEOTM Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to TI during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.
WARNING: This device is not approved 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/K062831 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062831: Modification to Life Spine Neo Anterior 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/K062831
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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