510(k) Report

510(k) · Cleared

Recalled · 2009

Mantis Spinal System

K061813510(k) TraditionalCleared Sep 19, 200684-day reviewClass II21 CFR 888.3070Recalls 2

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

Stryker Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Sep 19, 2006 as substantially equivalent to K043473 (Stryker Spine, 2005) and 7 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1995. 135 later devices descend from it. It has been recalled 2 times.

Decided
Sep 19, 2006
Review
84 days
Class
Class II
Product code
MNH
Recalls
2
Predicates
8

Its longest line of descent runs back 4 generations to K950697 (1995). 20 ancestors in all. 135 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2001: 2 other ancestors2000: 2 other ancestors1999: 1 other ancestor1995: 1 other ancestor2004: 2 other ancestors2003: 3 other ancestors1997: 1 other ancestor2002: 1 other ancestor2012: 5 descendants cleared2009: 1 descendant cleared2013: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2015: 4 descendants cleared2020: 11 descendants cleared2014: 3 descendants cleared2018: 10 descendants cleared2017: 8 descendants cleared2023: 21 descendants cleared2011: 2 descendants cleared2016: 3 descendants cleared2024: 18 descendants cleared2021: 3 descendants cleared2019: 9 descendants cleared2022: 10 descendants cleared2026: 12 descendants cleared2025: 12 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: 7 other ancestors2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 11 descendants3 generations forward: 30 descendants4 generations forward: 36 descendants5 generations forward: 26 descendants6 generations forward: 16 descendants7 generations forward: 8 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 deviceK061813 Mantis Spinal SystemStryker Spine · 2006
  6. Descendant · cites it directly · 111 of its ownK073151 Mantis Spinal SystemStryker Corp. · 2007
  7. Descendant · cites it directly · 110 of its ownK092631 Mantis Redux Spinal SystemStryker Spine · 2009
  8. Descendant · 2 generations on · 109 of its ownK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
  9. Descendant · 3 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
  10. Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013

Showing 5 of 135 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12011: 22012: 52013: 12014: 32015: 42016: 32017: 82018: 102019: 92020: 112021: 32022: 102023: 212024: 182025: 122026: 12
2007high 21 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 135 · See all
  • K073151Mantis Spinal SystemStryker Corp. · 2007 · cites it directly111descendants
  • K092631Mantis Redux Spinal SystemStryker Spine · 2009 · cites it directly110descendants
  • K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010 · 2 generations on109descendants
  • K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 3 generations on85descendants
  • 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

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)K061813Mantis Spinal SystemStryker Spine2006—
+1K073151Mantis Spinal SystemStryker Corp.2007—
+1K092631Mantis Redux Spinal SystemStryker Spine2009—
+2K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010—
+3K103292Trio Trauma Spinal SystemStryker Corporation2011—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal…Stryker Spine2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
199910
200020
200120
200210
200330
200420
200520
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201120
201250
201310
201430
201540
201630
201780
2018100
201990
2020110
202130
2022100
2023210
2024180
2025120
2026120
FIG. 1 — Lineage of K061813, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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
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What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043473Modification to Xia Spinal System
Summary page 1
…July 31, 2006 Predicate Device Identification The predicate devices are: Stryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (510(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-ben…
Stryker Spine2005—
*K060361Xia Spinal System, Xia 4.5 Spinal System
Summary page 1
…July 31, 2006 Predicate Device Identification The predicate devices are: Stryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (510(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k)…
Stryker Spine20061
*K002858Xia Spine System
Summary page 1
…s are: Stryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (510(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal Sy…
Howmedica Osteonics Corp.2000—
*K013823Xia Spinal System
Summary page 1
…ryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (510(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal System (K00…
Howmedica Osteonics Corp.2001—
*K951725Osteonics Spinal System
Summary page 1
…screws (510(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal System (K001255), and DePuy Spine, Inc. VIPERTM Spine System (K061520).…
Osteonics Corp.1995—
*K984251Xia Spine System
Summary page 1
…10(k) #K043473 and #K060361), Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal System (K001255), and DePuy Spine, Inc. VIPERTM Spine System (K061520). === Page…
Howmedica, Inc.1999—
*K001255CD Horizon Spinal System
Summary page 1
…l System polyaxial screws (K002858, K013823), Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal System (K001255), and DePuy Spine, Inc. VIPERTM Spine System (K061520). MANTISTM Spinal System…
Medtronic Sofamor Danek, Inc.2000—
*K061520Viper Spine System
Summary page 1
…Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361), Sofamor Danek CD Horizon® Spinal System (K001255), and DePuy Spine, Inc. VIPERTM Spine System (K061520). MANTISTM Spinal System Traditional 510(k) Premarket Notification D…
Depuy Spine, Inc.2006—

Also cleared against K043473: 10 other devices →

What descends from it? (135)

See all 135

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

NumberDeviceApplicantDecidedDescendants
K073151Mantis Spinal SystemStryker Corp.2007111
K092631Mantis Redux Spinal SystemStryker Spine2009110
K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384
K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226
K120714Picasso Mis Spinal Fixation SystemAccel Spine20122

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 30, 2009Not classifiedZ-1612-2009Device DesignThe Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall…
Apr 30, 2009Not classifiedZ-1611-2009Device DesignThe Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 1 of the 20 ancestors has a recall of any class.
  • Of its descendants, K073151 (Stryker Corp., 2007) has gone furthest, with 111 descendants of its own.
  • 10 other devices also cite its predicate K043473.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The MANTISTM Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation 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.

Indications for use as stated in the FDA summary.

Also cleared against K043473

10 other devices cite the same predicate.

  • K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio…Stryker Spine · 2013
  • K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011
  • K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
  • K092631Mantis Redux Spinal SystemStryker Spine · 2009
  • K073151Mantis Spinal SystemStryker Corp. · 2007
  • K071945S4 Spinal SystemAesculap Implant Systems · 2007

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K061813 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061813: Mantis 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/K061813

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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