510(k) · Cleared
ClearedLife Spine Lumbar Fixation System (SENTRY)
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 Jun 22, 2018 as substantially equivalent to K172131 (Life Spine, Inc., 2017) and 1 other predicate after a 151-day review. Its family tree reaches back 10 generations to 1999. 9 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 151 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K990745 (1999). 47 ancestors in all, the oldest K922543 (1993). 9 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 2 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 1 generation backK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- This deviceK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253748 Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated…Life Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251502 TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 4 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 3 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 2 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 1 generation backK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- This deviceK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200338ProLift Lateral FixatedLife Spine, Inc. · 2020 · cites it directly5descendants
- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 2 generations on3descendants
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · 3 generations on1descendant
- K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026 · 2 generations on0descendants
- K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −4 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −3 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −2 | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| −1 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| 0 (this device) | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
| +1 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| +2 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +3 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
| +2 | K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable… | Life Spine, Inc. | 2026 | — |
| +2 | K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025 | — |
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 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K172131 | 2 Hole Lateral Plating SystemSummary page 4…Spinal Intervertebral Body Fixation Orthosis Classification: KWQ, 21 CFR 888.3060, Class II Primary Predicate : Life Spine Sentry 2 (K172131) Secondary Predicate: Life Spine Presidio (K132589) Device Description: Anterior Lumbar The SENTRY Anterior Lumbar Fixa… | 2017 |
| * | K132589 | Anterior Lumbar Plate System (Presidio)Summary page 4…hosis Classification: KWQ, 21 CFR 888.3060, Class II Primary Predicate : Life Spine Sentry 2 (K172131) Secondary Predicate: Life Spine Presidio (K132589) Device Description: Anterior Lumbar The SENTRY Anterior Lumbar Fixation System consists of a variety of plates and screws to… | 2013 |
What descends from it? (9)
4 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 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 47 ancestors have a recall of any class.
- Of its descendants, K200338 (Life Spine, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K172131.
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. 2018, 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 Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor…
Read the full statement (107 words)
The Life Spine Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180166: Life Spine Lumbar Fixation System (SENTRY).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180166
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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