510(k) · Cleared
ClearedPilot Posterior Lumbar Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 5, 2006 after a 112-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Sep 5, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK061364 Pilot Posterior Lumbar Plating SystemLife Spine · 2006
- Descendant · cites it directly · 2 of its ownK142939 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015
- Descendant · cites it directly · 1 of its ownK160216 Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK163056 Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017
Most influential descendants
Showing 3 of 3 · See all- K142939Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015 · cites it directly2descendants
- K160216Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016 · cites it directly1descendant
- K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061364 | Pilot Posterior Lumbar Plating System | Life Spine | 2006 | — |
| +1 | K142939 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | 2015 | — |
| +1 | K160216 | Revolution Spinal Fixation System | Intelligent Implant Systems, LLC | 2016 | — |
| +2 | K163056 | Revolution™ Spinal Fixation System | Intelligent Implant Systems, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 MNH? 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? (3)
2 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, K142939 (Intelligent Implant Systems, LLC, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place 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 PILOTTM Posterior Lumbar Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It…
Read the full statement (186 words)
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place 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 PILOTTM Posterior Lumbar Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
The PILOTTM Posterior Lumbar Plating System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation) (4) spinal stenosis, (5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061364: Pilot Posterior Lumbar Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061364
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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