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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 7, 2011 as substantially equivalent to K063601 (Life Spine, 2007) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1995. 13 later devices descend from it.
- Decided
- Sep 7, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951725 (1995). 8 ancestors in all, the oldest K950697 (1995). 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- 2 generations backK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- 1 generation backK063601 Pilot Spinal SystemLife Spine · 2007
- This deviceK111729 Pilot Spinal SystemLife Spine, Inc. · 2011
- Descendant · cites it directly · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · cites it directly12descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 2 generations on10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 2 generations on9descendants
- K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 3 generations on5descendants
- K183430Modular Spinal Fixation SystemLife Spine, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −2 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| −1 | K063601 | Pilot Spinal System | Life Spine | 2007 | — |
| 0 (this device) | K111729 | Pilot Spinal System | Life Spine, Inc. | 2011 | — |
| +1 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +2 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +2 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| +3 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | — |
| +2 | K183430 | Modular Spinal Fixation System | Life Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K063601 | Pilot Spinal SystemSummary page 1…Pedicle screw spinal system Classification: Class II1 Product Code: NKB3, MNH, MNI Predicate Device: PILOT Spinal System (K063601), (K083865) Device Description: The PILOT®'Spinal System consists of an assortment of rods, screws, and bodies in various sha… | 2007 |
| * | K083865 | Pilot Spinal SystemSummary page 1…Pedicle screw spinal system Classification: Class II1 Product Code: NKB3, MNH, MNI Predicate Device: PILOT Spinal System (K063601), (K083865) Device Description: The PILOT®'Spinal System consists of an assortment of rods, screws, and bodies in various shapes and siz… | 2009 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151196 | Nautilus Spinal System | 2015 | 12 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K151196 (Life Spine, Inc., 2015) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K063601.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 PILOT® 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 PILOT® 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 PILOT 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/K111729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111729: Pilot 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/K111729
Report an extraction error
Are you the manufacturer?
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