510(k) · Cleared
ClearedTrifix Pedicle Spinal Screw Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 26, 1999 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 26, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNH? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. ‘The device syste consisting scrcws, washers, spacers, utilizing the anterotateralanterior surgical approach is intended for the following uses: (a) antcrolateral screw fixation to the non-cervical spine, (b) anteriar screw fixution ta the cervical spine The anterolateral/anterior system is intended for use in the following indications: (1) Degenerative disc diseasc of the Jumbur thoracic and cervical spine relating to discogenic arigin with…
Read the full statement (277 words)
1. ‘The device syste consisting scrcws, washers, spacers, utilizing the
anterotateralanterior surgical approach is intended for the following uses:
(a) antcrolateral screw fixation to the non-cervical spine,
(b) anteriar screw fixution ta the cervical spine
The anterolateral/anterior system is intended for use in the following indications:
(1) Degenerative disc diseasc of the Jumbur thoracic and cervical spine relating to
discogenic arigin with degeneration of the disc as confirmed by patient history and radiographic studics.
(b) Spondylolisthesis
(<) Trauma
(d) Spinal Stenosis
(e} Scalivsis
{t) Kyphosis
(¢} Tumor
(h) Pseudoarthrosts
(1) Revision of previous surgery
(j) Ncoplastia
2. The device system consisting of hooks, screws, washers, spacers, when utilized as a
non-pedicle posterior systent has the follawing intended uve:
(2) hook aad sucral/tliac screw fixation ta the non-cervical spinc
The non-pedicle posterior devices may be used for the followiag indications:
(1) Degenerative disc discase of the Jumbar thoracic and ccrvical spine relating to
discogenic origin with degeneration of the disc as confirmed by patient history
and radiographic swdies.
(b) Spondylolisthesis
(<) Treawmna
(d) Spinal Stenosis @
n-Off)
(¢) Scoliosix (Division\\ig
Division of General
(!) K)’phu.\'i.\"
510) Nomber """""‘"""was®
{e) Tuwinor
(h) Pscudouarthrosis
(1) Revision of previous surgery
Q) Necoplastia
3. The device system consisting of hooks, spaccrs, sacral/iliac screws and pedicle screws
is intended for paticnts:
(a) Having a scvere spondyloslisthesis (grades 3 and 4) at the [.5-S1 joint
(b) Who are reeciving fusions using autogenous bone graft only
(¢) Who are having the device [ixed or attached 10 the tumbar and <acral spine
(d) Who are having the device removed after the development of a solid fusion mass
‘The levels of pedicic screws fixation will be 1.3-S1.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990657: Trifix Pedicle Spinal Screw Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026