510(k) · Cleared
ClearedSentinel Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 11, 2009 as substantially equivalent to K070573 (Synthes Spine Co.Lp, 2007) and 3 other predicates after a 182-day review. Its family tree reaches back 2 generations to 2002. 21 later devices descend from it.
- Decided
- Aug 11, 2009
- Review
- 182 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K023675 (2002). 6 ancestors in all, the oldest K010681 (2001). 21 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK023675 Synthes Cervifix/ AxonSynthes (Usa) · 2002
- 1 generation backK070573 Synapse SystemSynthes Spine Co.Lp · 2007
- This deviceK090343 Sentinel Spinal SystemLife Spine · 2009
- Descendant · cites it directly · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 2 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 3 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · 3 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · cites it directly13descendants
- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 2 generations on12descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 3 generations on10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 3 generations on9descendants
- K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023675 | Synthes Cervifix/ Axon | Synthes (Usa) | 2002 | — |
| −1 | K070573 | Synapse System | Synthes Spine Co.Lp | 2007 | — |
| 0 (this device) | K090343 | Sentinel Spinal System | Life Spine | 2009 | — |
| +1 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +2 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +3 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +3 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| +4 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K070573 | Synapse SystemSummary page 1…pinal Interlaminal Fixation Orthosis. Predidate Devices: Synthese Synapse System (K070573), Biomet Altius OCT System (K043229), Stryker Spine OASYS TM… | 2007 |
| * | K043229 | Modification to Altius Oct SystemSummary page 1…Fixation Orthosis. Predidate Devices: Synthese Synapse System (K070573), Biomet Altius OCT System (K043229), Stryker Spine OASYS TM System (K032394), and Depuy SUMMITTM OCT Spinal… | 2004 |
| * | K032394 | Stryker Spine Oasys SystemSummary page 1…System (K070573), Biomet Altius OCT System (K043229), Stryker Spine OASYS TM System (K032394), and Depuy SUMMITTM OCT Spinal System (K010681) Device Description: The SENTI… | 2004 |
| * | K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…3229), Stryker Spine OASYS TM System (K032394), and Depuy SUMMITTM OCT Spinal System (K010681) Device Description: The SENTINELTM Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multip… | 2001 |
What descends from it? (21)
See all 215 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 4.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K141222 (Life Spine, Inc., 2015) has gone furthest, with 13 descendants of its own.
- 9 other devices also cite its predicate K070573.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation…
Read the full statement (145 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090343: Sentinel Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090343
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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