510(k) · Cleared
ClearedLife Spine Facet Screw Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · MRW System, Facet Screw Spinal Device
Cleared on Jun 26, 2009 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) after an 88-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jun 26, 2009
- Review
- 88 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020411 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- This deviceK090865 Life Spine Facet Screw Spinal SystemLife Spine · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| 0 (this device) | K090865 | Life Spine Facet Screw Spinal System | Life Spine | 2009 | — |
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 MRW? 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 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 |
|---|---|---|---|
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 1…MRW, Facet Screw Spinal Device Classification: Unclassified Predicate Device: NuVasiveTM TriadTM Facet Screw System (K02041 1) Device Description: The Life Spine Facet Screw Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F… | 2002 |
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?
- Its one ancestor has no recall.
- 10 other devices also cite its predicate K020411.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The Life Spine Facet Screw Spinal System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spondylosis, fracture, degeneration of the facets with instability, pseudoarthrosis, and failed previous fusion. The Life Spine Facet Screw System, when properly used, is…
Read the full statement (128 words)
The Life Spine Facet Screw Spinal System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spondylosis, fracture, degeneration of the facets with instability, pseudoarthrosis, and failed previous fusion.
The Life Spine Facet Screw System, when properly used, is intended to stabilize the spine as an aid to fusion through bilateral-immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Life Spine Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from L1 to S1.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090865: Life Spine Facet Screw 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/K090865
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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