510(k) · Cleared
ClearedAcme Talon Pedicle Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acme Spine, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 4, 2007 after a 63-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 103 later devices descend from it.
- Decided
- Sep 4, 2007
- Review
- 63 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
103 later devices descend from it, 6 citing it directly.
- This deviceK071824 Acme Talon Pedicle ScrewAcme Spine, LLC · 2007
- Descendant · cites it directly · 91 of its ownK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- Descendant · 2 generations on · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 3 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 4 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- Descendant · 5 generations on · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K081331Fixxsure Cross LinkSpineworks, LLC · 2008 · cites it directly91descendants
- K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on89descendants
- K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 3 generations on88descendants
- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 4 generations on82descendants
- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · 5 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071824 | Acme Talon Pedicle Screw | Acme Spine, LLC | 2007 | — |
| +1 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| +2 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +3 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +4 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| +5 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 12 | 0 |
| 2024 | 16 | 0 |
| 2025 | 16 | 0 |
| 2026 | 16 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K001044 | FDA’s K001044 is Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
What descends from it? (103)
See all 1036 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, K081331 (Spineworks, LLC, 2008) has gone furthest, with 91 descendants of its own.
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?
The Acme 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 (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071824: Acme Talon Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071824
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