510(k) · Cleared
ClearedModification to: Trio+Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 12, 2010 as substantially equivalent to K052971 (Stryker Spine, 2005) and 4 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1995. 86 later devices descend from it.
- Decided
- Apr 12, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K950697 (1995). 21 ancestors in all. 86 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK070368 Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007
- This deviceK100737 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
- Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · 2 generations on · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- Descendant · 3 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- 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
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
- K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · 2 generations on31descendants
- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | Stryker Corp. | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +2 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| +3 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K052971 | Stryker Spine Trio Spinal Fixation SystemSummary page 1…om Date Summary Prepared: April 9, 2010 Predicate Devices * Stryker Spine TRIO Spinal Fixation System, K052971; * Stryker Spine TRIO and TRIO+ Spinal Systems,… | 2005 |
| * | K062698 | Trio + Spinal SystemSummary page 1…stem, K052971; * Stryker Spine TRIO and TRIO+ Spinal Systems, K062698, K070368. * Medtronic Sofamor Danek TSRH Spinal System,… | 2006 |
| * | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemSummary page 1…2971; * Stryker Spine TRIO and TRIO+ Spinal Systems, K062698, K070368. * Medtronic Sofamor Danek TSRH Spinal System,… | 2007 |
| * | K020699 | TSRH Spinal SystemSummary page 1…62698, K070368. * Medtronic Sofamor Danek TSRH Spinal System, K020699, K02I1170.… | 2002 |
| * | K021170 | TSRH Spinal System | 2002 |
What descends from it? (86)
See all 862 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K103292 (Stryker Corporation, 2011) has gone furthest, with 85 descendants of its own.
- 5 other devices also cite its predicate K052971.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: *Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis; * Trauma…
Read the full statement (114 words)
The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
*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;
* Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor;
* Pseudoarthrosis; and
* Failed previous fusion.
The TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axia Cross Connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100737: Modification to: Trio+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/K100737
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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