510(k) · Cleared
ClearedLife Spine ALIF Buttress Plate 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 Nov 16, 2022 as substantially equivalent to K180755 (Evolution Spine, LLC, 2018) and 2 other predicates after a 77-day review. Its family tree reaches back 11 generations to 1999.
- Decided
- Nov 16, 2022
- Review
- 77 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K990745 (1999). 53 ancestors in all, the oldest K922543 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 2 generations backK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- 1 generation backK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- This deviceK222628 Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 5 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 4 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 3 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 2 generations backK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- 1 generation backK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- This deviceK222628 Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −5 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −4 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −3 | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| −2 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| −1 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
| 0 (this device) | K222628 | Life Spine ALIF Buttress Plate System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K180755 | Vail ALIF Buttress Plate SystemSummary page 4…KWQ, 21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis, Class II Primary Predicate: Vail Buttress Plate System (K180755) Additional Predicate: RCS Anterior Buttress Plate System (K092659) Life Spine Sentry Lateral… | 2018 |
| * | K092659 | Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25Summary page 4…Class II Primary Predicate: Vail Buttress Plate System (K180755) Additional Predicate: RCS Anterior Buttress Plate System (K092659) Life Spine Sentry Lateral Plate System (K180166) Device Description: The Life Spine ALIF Buttress… | 2009 |
| * | K180166 | Life Spine Lumbar Fixation System (SENTRY)Summary page 4…ress Plate System (K180755) Additional Predicate: RCS Anterior Buttress Plate System (K092659) Life Spine Sentry Lateral Plate System (K180166) Device Description: The Life Spine ALIF Buttress Plate System consists of a variety of plates and screws to suit the individua… | 2018 |
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 23 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 53 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. 2022, 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 ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222628: Life Spine ALIF Buttress Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222628
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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