510(k) · Cleared
ClearedStryker Spine Trio PS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 2, 2005 as substantially equivalent to K013823 (Howmedica Osteonics Corp., 2001) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1995. 88 later devices descend from it.
- Decided
- Mar 2, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951725 (1995). 2 ancestors in all. 88 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- This deviceK043180 Stryker Spine Trio PSStryker Spine · 2005
- Descendant · cites it directly · 87 of its ownK070368 Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007
- Descendant · 2 generations on · 86 of its ownK100737 Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010
- Descendant · 3 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
- Descendant · 2 generations on · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · 3 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007 · cites it directly87descendants
- K100737Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010 · 2 generations on86descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 3 generations on85descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · 2 generations on84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 3 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| 0 (this device) | K043180 | Stryker Spine Trio PS | Stryker Spine | 2005 | — |
| +1 | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | Stryker Corp. | 2007 | — |
| +2 | K100737 | Modification to: Trio+Spinal Fixation System | Stryker Spine | 2010 | — |
| +3 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
| +2 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +3 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 15 | 0 |
| 2024 | 16 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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 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? (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 |
|---|---|---|---|
| * | K013823 | Xia Spinal SystemSummary page 1…bricated from titanium alloy. The components of the TRIO® PS System will be provided non-sterile. Predicate Devices: Xia Spinal System, Howmedica Osteonics Corporation [K013823] Osteonics® Spinal System, Osteonics Corporation [K951725] Intended Use The Stryker Spine TRIO® PS is a posterior, noncervical (… | 2001 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…PS System will be provided non-sterile. Predicate Devices: Xia Spinal System, Howmedica Osteonics Corporation [K013823] Osteonics® Spinal System, Osteonics Corporation [K951725] Intended Use The Stryker Spine TRIO® PS is a posterior, noncervical (TI0-S 1), pedicle system intended to provide immobilizatio… | 1995 |
What descends from it? (88)
See all 881 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | 2007 | 87 |
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 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?
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1). pediole 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 spine: severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesls with objective evidence of neurologic impairment, trauma (i.e.…
Read the full statement (140 words)
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1). pediole 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 spine: severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesls with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) tumor, pseudoarthrosis, and previous failed fusion.
The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for degenerative disc disease (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, deformities or curvatures (I.e,, scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and previous failed fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043180: Stryker Spine Trio PS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043180
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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