510(k) · Cleared
Recalled · Class II · 2012Trio + Spinal 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 Oct 11, 2006 as substantially equivalent to K032855 (Howmedica Osteonics, 2003) and 6 other predicates after a 30-day review. Its family tree reaches back 2 generations to 2000. 88 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 11, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 2 generations to K002858 (2000). 11 ancestors in all, the oldest K950697 (1995). 88 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002858 Xia Spine SystemHowmedica Osteonics Corp. · 2000
- 1 generation backK043473 Modification to Xia Spinal SystemStryker Spine · 2005
- This deviceK062698 Trio + Spinal SystemStryker Spine · 2006
- 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 · 2 generations on · 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
- Descendant · 2 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 · cites it directly86descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 2 generations on85descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002858 | Xia Spine System | Howmedica Osteonics Corp. | 2000 | — |
| −1 | K043473 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| 0 (this device) | K062698 | Trio + Spinal System | Stryker Spine | 2006 | — |
| +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 | — |
| +2 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
| +1 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 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 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? (7)
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…System 87 MNI: Orthosis, Spinal, Pedicle Fixation Predicate Device Information: K032855 - Stryker Spine MAPS System (renamed Stryker Spine Trio® System)… | 2003 |
| * | K052971 | Stryker Spine Trio Spinal Fixation SystemSummary page 1…2855 - Stryker Spine MAPS System (renamed Stryker Spine Trio® System) K052971 - Stryker Spine TRIO' Spinal System… | 2005 |
| * | K013823 | Xia Spinal SystemSummary page 1…K052971 - Stryker Spine TRIO' Spinal System K013823, K043473 - Stryker Spine Xia Spinal System… | 2001 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 1…K052971 - Stryker Spine TRIO' Spinal System K013823, K043473 - Stryker Spine Xia Spinal System… | 2005 |
| * | K012870 | Xia Stainless Steel SystemSummary page 1…K013823, K043473 - Stryker Spine Xia Spinal System K0 12870 - Stryker Spine Xia® Stainless Steel System… | 2001 |
| * | K050461 | Xia 4.5 Spinal SystemSummary page 1…K0 12870 - Stryker Spine Xia® Stainless Steel System K050461 -Stryker Spine Mio 4.5 Spinal System… | 2005 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…K050461 -Stryker Spine Mio 4.5 Spinal System K95 1725 - Stryker Spine Olsteonics Spinal System Line Extension to (he… | 1995 |
What descends from it? (88)
See all 883 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2012 | Class II | Z-2235-2012 | Labeling mix-ups | The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use… |
| Jul 1, 2009 | Not classified | Z-1886-2009 | Other | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K070368 (Stryker Corp., 2007) has gone furthest, with 87 descendants of its own.
- 2 other devices also cite its predicate K032855.
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 TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, kyphosis, spinal tumor and…
Read the full statement (234 words)
The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The TRIO®and TRIO®+ Spinal Systems are 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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts.
The TRIO® Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
The TRIO®+ Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, XiMa Pre-bent Rods, and the Multi-Axis Cross Connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062698: Trio + Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062698
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