510(k) · Cleared
Recalled · 2009Stryker Spine Trio Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 16, 2005 as substantially equivalent to K032855 (Howmedica Osteonics, 2003) and 3 other predicates after a 23-day review. Its family tree reaches back 1 generation to 1995. 112 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 16, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K951725 (1995). 4 ancestors in all. 112 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- This deviceK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005
- Descendant · cites it directly · 88 of its ownK062698 Trio + Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · cites it directly · 87 of its ownK070368 Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007
- Descendant · cites it directly · 86 of its ownK100737 Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010
- Descendant · cites it directly · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
- Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K062698Trio + Spinal SystemStryker Spine · 2006 · cites it directly88descendants
- K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007 · cites it directly87descendants
- K100737Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010 · cites it directly86descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · cites it directly85descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
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) | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | — |
| +1 | K062698 | Trio + Spinal System | Stryker Spine | 2006 | 2 |
| +1 | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | Stryker Corp. | 2007 | — |
| +1 | K100737 | Modification to: Trio+Spinal Fixation System | Stryker Spine | 2010 | — |
| +1 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
| +1 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K032855 | Stryker Spine Maps SystemSummary page 1…87 MNI: Orthosis, Spinal, Pedicle Fixation Predicate Device Information: K032855 - Stryker Spine MAPS System K95 1725 - Osteonics Spinal System… | 2003 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…ation Predicate Device Information: K032855 - Stryker Spine MAPS System K95 1725 - Osteonics Spinal System KO 13823 - Xia Spinal System… | 1995 |
| * | K013823 | Xia Spinal SystemSummary page 3…redicate device: Stryker Spine MAPS System (K032855). Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Xia Spinal System (KG013823), Xia Stainless Steel System (K012870) and Osteonics Spinal System (K95 1725).… | 2001 |
| * | K012870 | Xia Stainless Steel SystemSummary page 1…Spinal System KO 13823 - Xia Spinal System K012870 - Xia Stainless Steel System 92.. 7… | 2001 |
What descends from it? (112)
See all 1126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062698 | Trio + Spinal System | 2006 | 88 |
| K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | 2007 | 87 |
| K100737 | Modification to: Trio+Spinal Fixation System | 2010 | 86 |
| K103292 | Trio Trauma Spinal System | 2011 | 85 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K063601 | Pilot Spinal System | 2007 | 24 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2009 | Not classified | Z-1886-2009 | Other | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
| Sep 5, 2006 | Not classified | Z-0986-2009 | Device Design | Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down. |
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.
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 Stryker Spine TRIO® Spinal Fixation 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal…
Read the full statement (216 words)
The Stryker Spine TRIO® Spinal Fixation 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac 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 (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052971: Stryker Spine Trio Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052971
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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