510(k) · Cleared
ClearedLife Spine 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 Mar 13, 2007 as substantially equivalent to K040844 (Life Spine, LLC, 2004) after a 43-day review. Its family tree reaches back 2 generations to 2000. 57 later devices descend from it.
- Decided
- Mar 13, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002592 (2000). 3 ancestors in all. 57 later devices descend from it, 4 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 deviceK070285 Life Spine Anterior Cervical Plate SystemLife Spine · 2007
- Descendant · cites it directly · 52 of its ownK073479 Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008
- Descendant · 2 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
- Descendant · 3 generations on · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008 · cites it directly52descendants
- K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 2 generations on51descendants
- K130202Iris Anterior Cervical PlateLife Spine, Inc. · 2013 · cites it directly21descendants
- K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · 3 generations on19descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
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) | K070285 | Life Spine Anterior Cervical Plate System | Life Spine | 2007 | — |
| +1 | K073479 | Kinetic-SL Anterior Cervical Plate System | Life Spine | 2008 | — |
| +2 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| +1 | K130202 | Iris Anterior Cervical Plate | Life Spine, Inc. | 2013 | — |
| +3 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| +2 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040844 | Life Spine Neo Anterior Cervical Plate SystemSummary page 1…ClIass II Device lProduct Code: KWQ Predicate ei~cve: Life Spine Nl-iO(V Cervical Plating System K040844 Life Spine KINTIMC 'Anterior Cervical Plate K062043 Device IDescription: 'Me Life Spine An… | 2004 |
| Kept off the family tree | K062043 | FDA’s K062043 is Body Composition Monitor with Scale, Model HBF-500 Our reading of the summary gave K062043, FDA’s number for Body Composition Monitor with Scale, Model HBF-500 (Omron Healthcare, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Life Spine KINTIMC Anterior Cervical Plate”. Kept off the family tree. Summary page 1…redicate ei~cve: Life Spine Nl-iO(V Cervical Plating System K040844 Life Spine KINTIMC 'Anterior Cervical Plate K062043 Device IDescription: 'Me Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bonec plates% and sc… | 2006 |
What descends from it? (57)
See all 574 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?
- The line of descent spans 7 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, K073479 (Life Spine, 2008) has gone furthest, with 52 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. 2007, 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 Life Spine 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 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)…
Read the full statement (134 words)
The Life Spine 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 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.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for screw attachment 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/K070285 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070285: Life Spine Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070285
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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