510(k) · Cleared
ClearedTalon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine360 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 2, 2011 as substantially equivalent to K071824 (Acme Spine, LLC, 2007) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Feb 2, 2011
- Review
- 117 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001044 (2000). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001044 Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw…Acme Spine, LLC · 2000
- This deviceK102995 Talon Spinal SystemSpine360 · 2011
- Descendant · cites it directly · 1 of its ownK241494 Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024
- Descendant · 2 generations on · 0 of its ownK252219 Cervical Interbody and VBR Fusion SystemSync Surgical · 2026
- Descendant · cites it directly · 0 of its ownK152920 Savannah-T® Pedicle Screw SystemAmendia, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK153152 Syzygy Stabilization SystemAmendia, Inc. · 2016 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024 · cites it directly1descendant
- K252219Cervical Interbody and VBR Fusion SystemSync Surgical · 2026 · 2 generations on0descendants
- K152920Savannah-T® Pedicle Screw SystemAmendia, Inc. · 2016 · cites it directly0descendants
- K153152Syzygy Stabilization SystemAmendia, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001044 | Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System | Acme Spine, LLC | 2000 | — |
| 0 (this device) | K102995 | Talon Spinal System | Spine360 | 2011 | — |
| +1 | K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal | 2024 | — |
| +2 | K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026 | — |
| +1 | K152920 | Savannah-T® Pedicle Screw System | Amendia, Inc. | 2016 | 1 |
| +1 | K153152 | Syzygy Stabilization System | Amendia, Inc. | 2016 | 2 |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K071824 | Acme Talon Pedicle ScrewSummary page 1…88.3070 - Pedicle Screw Spinal System CLASS 11,MNH 858.3070 - Pedicle Screw Spinal System PREDICATE DEVICE Talon Spinal Fixation Systemi(K071824) Acme Spine System (K0010044) The Spine 360… | 2007 |
| * | K001044 | Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System | 2000 |
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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Spine 360 Talon Spinal 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102995: Talon 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/K102995
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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