510(k) · Cleared
ClearedTriple-Fix Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Spine Technology, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 28, 2000 after a 249-day review. The FDA summary names its predicate without a number. 451 later devices descend from it.
- Decided
- Feb 28, 2000
- Review
- 249 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
451 later devices descend from it, 3 citing it directly.
- This deviceK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- Descendant · cites it directly · 450 of its ownK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- Descendant · 2 generations on · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- Descendant · 2 generations on · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- Descendant · 2 generations on · 179 of its ownK062513 Apex Spine SystemSpinecraft, Inc. · 2006
- Descendant · cites it directly · 179 of its ownK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
Showing 5 of 451 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 451 · See all- K001668Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000 · cites it directly450descendants
- K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · 2 generations on181descendants
- K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · 2 generations on180descendants
- K062513Apex Spine SystemSpinecraft, Inc. · 2006 · 2 generations on179descendants
- K031455Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003 · cites it directly179descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| +1 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| +2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| +2 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| +2 | K062513 | Apex Spine System | Spinecraft, Inc. | 2006 | — |
| +1 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 7 | 0 |
| 2010 | 13 | 0 |
| 2011 | 12 | 0 |
| 2012 | 13 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 25 | 0 |
| 2016 | 21 | 0 |
| 2017 | 30 | 0 |
| 2018 | 27 | 0 |
| 2019 | 18 | 0 |
| 2020 | 25 | 0 |
| 2021 | 22 | 0 |
| 2022 | 27 | 0 |
| 2023 | 39 | 0 |
| 2024 | 41 | 0 |
| 2025 | 33 | 0 |
| 2026 | 35 | 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 |
|---|---|---|---|
| * | — | Isola Spinal System Named without a submission number | |
| * | — | Mirage Spinal System Named without a submission number |
What descends from it? (451)
See all 4513 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, K001668 (D.K.M. Co., Ltd., 2000) has gone furthest, with 450 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.
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 Triple-Fix Spinal System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (182 words)
The Triple-Fix Spinal System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The posterior Triple-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The posterior Triple-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992147: Triple-Fix Spinal 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/K992147
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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