510(k) · Cleared
ClearedLife Spine Interspinous Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 5, 2010 after a 262-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Nov 5, 2010
- Review
- 262 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK100407 Life Spine Interspinous Fixation SystemLife Spine · 2010
- Descendant · cites it directly · 1 of its ownK121924 Integra Interspinous Process SystemSeaspine, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK113157 Aileron Interspinous Fixation SystemLife Spine · 2012
- Descendant · 2 generations on · 0 of its ownK173334 SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · cites it directly · 0 of its ownK140236 Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K121924Integra Interspinous Process SystemSeaspine, Inc. · 2013 · cites it directly1descendant
- K113157Aileron Interspinous Fixation SystemLife Spine · 2012 · cites it directly1descendant
- K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on0descendants
- K140236Aileron Interspinous Fixation SystemLife Spine, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100407 | Life Spine Interspinous Fixation System | Life Spine | 2010 | — |
| +1 | K121924 | Integra Interspinous Process System | Seaspine, Inc. | 2013 | — |
| +1 | K113157 | Aileron Interspinous Fixation System | Life Spine | 2012 | — |
| +2 | K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | 2018 | — |
| +1 | K140236 | Aileron Interspinous Fixation System | Life Spine, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 MNI? 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?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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?
- Of its descendants, K121924 (Seaspine, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The ARX® Spinal System, PILOT®D Spinal System, PILOT® Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the…
Read the full statement (266 words)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The ARX® Spinal System, PILOT®D Spinal System, PILOT® Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as posterior spine thoracic/lumbar systems, the ARIX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti-SI). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographib studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Life Spine Interspinous Fixation System is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100407: Life Spine Interspinous Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100407
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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