510(k) · Cleared
ClearedPantheon Pedicle Screw and Iliac Bolt Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pantheon Spinal · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 26, 2024 as substantially equivalent to K102995 (Spine360, 2011) after a 59-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jul 26, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001044 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001044 Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw…Acme Spine, LLC · 2000
- 1 generation backK102995 Talon Spinal SystemSpine360 · 2011
- This deviceK241494 Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024
- Descendant · cites it directly · 0 of its ownK252219 Cervical Interbody and VBR Fusion SystemSync Surgical · 2026
Most influential descendants
Showing 1 of 1 · See all- K252219Cervical Interbody and VBR Fusion SystemSync Surgical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001044 | Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System | Acme Spine, LLC | 2000 | — |
| −1 | K102995 | Talon Spinal System | Spine360 | 2011 | — |
| 0 (this device) | K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal | 2024 | — |
| +1 | K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K102995 | Talon Spinal SystemSummary page 4….3050, 888.3060, 888.3040 Reviewing Panel: Orthopedic Product Codes: NKB, KWP, KWQ, OUR Primary Predicate: Talon Spinal System (K102995) Reference Predicate: Outlet Sacroiliac Joint Fusion System (K181881) Device Description: The Pantheon Pedicle Screw… | 2011 |
| † | K181881 | Outlet Sacroiliac Joint Fusion System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252219 | Cervical Interbody and VBR Fusion System | 2026 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252219 (Sync Surgical, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K102995.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Pantheon Pedicle Screw System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic…
Read the full statement (116 words)
The Pantheon Pedicle Screw System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241494: Pantheon Pedicle Screw and Iliac Bolt 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/K241494
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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