510(k) · Cleared
ClearedPilot Spinal 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 Jan 25, 2007 as substantially equivalent to K950697 (Depuy Motech, 1995) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1995. 24 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 52 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951725 (1995). 6 ancestors in all, the oldest K950697 (1995). 24 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- 1 generation backK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- This deviceK063601 Pilot Spinal SystemLife Spine · 2007
- Descendant · cites it directly · 13 of its ownK111729 Pilot Spinal SystemLife Spine, Inc. · 2011
- 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 · cites it directly · 8 of its ownK082617 Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2009
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K111729Pilot Spinal SystemLife Spine, Inc. · 2011 · 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
- K082617Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2009 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −1 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| 0 (this device) | K063601 | Pilot Spinal System | Life Spine | 2007 | — |
| +1 | K111729 | Pilot Spinal System | Life Spine, Inc. | 2011 | — |
| +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 | — |
| +1 | K082617 | Trauson General Spinal System (GSS) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…MNH: Orthosis, spondylolisthesis spinalfixation Predicate Device: DePuy Moss Miami Spinal System K950697 Stryker Spine TRIO® Spinal Fixation System K052971 Device Description:… | 1995 |
| * | K052971 | Stryker Spine Trio Spinal Fixation SystemSummary page 1…redicate Device: DePuy Moss Miami Spinal System K950697 Stryker Spine TRIO® Spinal Fixation System K052971 Device Description: When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT'm Spinal System… | 2005 |
What descends from it? (24)
See all 243 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 12 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K111729 (Life Spine, Inc., 2011) has gone furthest, with 13 descendants of its own.
- 15 other devices also cite its predicate K950697.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 PILOTTM Spinal 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…
Read the full statement (157 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 PILOTTM Spinal 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.
When used as a posterior spine thoracic/lumbar system, the PILOTrm Spinal System is 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) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063601: Pilot Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063601
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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