510(k) Report

510(k) · Cleared

Cleared

Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System

K070368510(k) TraditionalCleared May 4, 200785-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Corp. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 4, 2007 as substantially equivalent to K043180 (Stryker Spine, 2005) and 4 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1995. 87 later devices descend from it.

Decided
May 4, 2007
Review
85 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K950697 (1995). 18 ancestors in all. 87 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 4 other ancestors2003: 3 other ancestors2001: 2 other ancestors1995: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2013: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2017: 5 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2023: 15 descendants cleared2018: 7 descendants cleared2020: 7 descendants cleared2024: 16 descendants cleared2021: 2 descendants cleared2019: 3 descendants cleared2022: 6 descendants cleared2016: 1 descendant cleared2026: 9 descendants cleared2025: 10 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 21 descendants4 generations forward: 24 descendants5 generations forward: 16 descendants6 generations forward: 10 descendants7 generations forward: 6 descendants8 generations forward: 3 descendants K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 19950+5
  1. Root · 4 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 3 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 2 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 1 generation backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. This deviceK070368 Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp. · 2007
  6. Descendant · cites it directly · 86 of its ownK100737 Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010
  7. Descendant · 2 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
  8. Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
  9. Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  10. Descendant · 2 generations on · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12013: 12014: 12015: 22016: 12017: 52018: 72019: 32020: 72021: 22022: 62023: 152024: 162025: 102026: 9
2010high 16 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 87 · See all
  • 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
  • K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−3K050461Xia 4.5 Spinal SystemStryker Spine2005—
−2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−1K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
0 (this device)K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.2007—
+1K100737Modification to: Trio+Spinal Fixation SystemStryker Spine2010—
+2K103292Trio Trauma Spinal SystemStryker Corporation2011—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal…Stryker Spine2013—
+2K142381Xia 3 Spinal SystemStryker Corp.2014—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200010
200120
200210
200330
200540
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201310
201410
201520
201610
201750
201870
201930
202070
202120
202260
2023150
2024160
2025100
202690
FIG. 1 — Lineage of K070368, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K043180Stryker Spine Trio PS
Summary page 1
…icle Screw Spinal System and Number [21 CER 888.3070(b) (1) & (b) (2)] Product Code NKB, MINH, and MMI Predicate Devices K043 180 - Stryker Spine Trio"' Plate System (PS) K060361 - Stryker Spine Xia'v and Xia * 4.5 Spinal Systems…
Stryker Spine2005—
*K060361Xia Spinal System, Xia 4.5 Spinal System
Summary page 1
…(b) (2)] Product Code NKB, MINH, and MMI Predicate Devices K043 180 - Stryker Spine Trio"' Plate System (PS) K060361 - Stryker Spine Xia'v and Xia * 4.5 Spinal Systems K060369 - Stryker Spine OpUSTM Spinal System D…
Stryker Spine20061
Kept off the family treeK060369FDA’s K060369 is Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak
Our reading of the summary gave K060369, FDA’s number for Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak… (Dade Behring, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Spine Opus Spinal System”. Kept off the family tree.
Summary page 1
…K043 180 - Stryker Spine Trio"' Plate System (PS) K060361 - Stryker Spine Xia'v and Xia * 4.5 Spinal Systems K060369 - Stryker Spine OpUSTM Spinal System Device Description The Stryker Spine Trio®v Plate System is comprised of spinal…
Dade Behring, Inc.20061
*K032855Stryker Spine Maps System
Summary page 3
…edicle Screw Spinal System and Number 21 CFR 888.3070(b) (1) & (b) (2) Product Code NKB, MNH, and MNI Predicate Devices K032855 - Stryker Spine MAPS System K052971 - Stryker Spine Trio® Spinal Fixation System…
Howmedica Osteonics20031
*K052971Stryker Spine Trio Spinal Fixation System
Summary page 3
….3070(b) (1) & (b) (2) Product Code NKB, MNH, and MNI Predicate Devices K032855 - Stryker Spine MAPS System K052971 - Stryker Spine Trio® Spinal Fixation System K060361 - Stryker Spine Xia " and Xia ' 4.5 Spinal Sys…
Stryker Spine20052
*K062698Trio + Spinal System
Summary page 5
…) Product Code NKB, MNH, and MNI Predicate Devices K052971 - Stryker Spine Trio® Spinal Fixation System K062698 - Stryker Spine Trio + Spinal System K060361 -Stryker Spine Xia® and Xia ® 4.5 Spinal Systems D…
Stryker Spine20062

What descends from it? (87)

See all 87

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086
K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384

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 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 18 ancestors have a recall of any class.
  • Of its descendants, K100737 (Stryker Spine, 2010) has gone furthest, with 86 descendants of its own.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T1 0-Sl) pedical and nonpedical fixation of the spine for the following indications: * Degenerative disc disease (DUD) (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)…

Read the full statement (280 words)

The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T1 0-Sl) pedical and nonpedical fixation of the spine for the following indications:

* Degenerative disc disease (DUD) (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 Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine.

The Stryker Spine Trio® Spinal Fixation System is indicated for:

* Degenerative disc disease (DDD) (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 Trioe Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine Trio®+ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine.

The Stryker Spine Trio®+ Spinal System is indicated for:

* Degenerative disc disease (ODD) (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®4 Spinal System is intended to be used in conjunction with the 055 Diapason Rods, Opus Spinal System Rods, Xia® Pre-bent Rods, and the Multi-Axis Cross Connectors.

Indications for use as stated in the FDA summary.

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Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
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https://510kreport.com/device/K070368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070368

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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