510(k) Report

510(k) · Cleared

Cleared

Xia 4.5 Spinal System

K050461510(k) TraditionalCleared Jul 27, 2005154-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 Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 27, 2005 as substantially equivalent to K002858 (Howmedica Osteonics Corp., 2000) and 3 other predicates after a 154-day review. Its family tree reaches back 1 generation to 1995. 1 of the 747 devices in its family, counting itself, has a Class I recall. 742 later devices descend from it.

Decided
Jul 27, 2005
Review
154 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K950697 (1995). 4 ancestors in all. 742 later devices descend from it, 12 citing it directly. 1 of the 747 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2006: 7 descendants cleared2016: 35 descendants cleared2014: 27 descendants cleared2011: 12 descendants cleared2007: 8 descendants cleared2013: 31 descendants cleared2005: 1 descendant cleared2018: 51 descendants cleared2009: 11 descendants cleared2015: 37 descendants cleared2010: 11 descendants cleared2012: 29 descendants cleared2017: 54 descendants cleared2023: 69 descendants cleared2020: 46 descendants cleared2008: 7 descendants cleared2024: 64 descendants cleared2025: 60 descendants cleared2021: 36 descendants cleared, 1 with a Class I recall12019: 46 descendants cleared2022: 45 descendants cleared2026: 55 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 12 descendants2 generations forward: 23 descendants3 generations forward: 47 descendants4 generations forward: 64 descendants5 generations forward: 89 descendants6 generations forward: 110 descendants7 generations forward: 126 descendants, 1 with a Class I recall18 generations forward: 120 descendants9 generations forward: 81 descendants10 generations forward: 41 descendants11 generations forward: 11 descendants12 generations forward: 6 descendants13 generations forward: 9 descendants14 generations forward: 3 descendants K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 19950+5+10
  1. Root · 1 generation backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. This deviceK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. Descendant · cites it directly · 735 of its ownK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. Descendant · 2 generations on · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. Descendant · 3 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. Descendant · 4 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. Descendant · 4 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009

Showing 5 of 742 descendants. See all descendants

Descendants cleared per year

2005: 12006: 72007: 82008: 72009: 112010: 112011: 122012: 292013: 312014: 272015: 372016: 352017: 542018: 512019: 462020: 462021: 362022: 452023: 692024: 642025: 602026: 55
2005high 69 (2023) · low 1 (2005)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 742 · See all
  • K052761Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005 · cites it directly735descendants
  • K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · 2 generations on734descendants
  • K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 3 generations on710descendants
  • K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 4 generations on518descendants
  • K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 4 generations on462descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
0 (this device)K050461Xia 4.5 Spinal SystemStryker Spine2005—
+1K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
+2K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
+3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
+4K090230Expedium Spine SystemDepuy Spine, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200670
200780
200870
2009110
2010110
2011120
2012290
2013310
2014270
2015370
2016350
2017540
2018510
2019460
2020460
2021361
2022450
2023690
2024640
2025600
2026550
FIG. 1 — Lineage of K050461, 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.

1 device in this family has a Class I recall. 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002858Xia Spine System
Summary page 1
…terior or anterolateral non cervical fixation. Predicate Device Identification The Xie 4.5 Spinal System is substantially equivalent to Stryker Spine Xia Spinal System (K002858), DePuy Spine MOSS MiamiTM Spinal System (K950697 and K962628) and Medtronic Sofamor Danek CD Horizon Legacy TM (K020709). K0…
Howmedica Osteonics Corp.2000—
*K950697Depuy Motech Moss Miami Spinal System - Pedicle Fixation
Summary page 1
…edicate Device Identification The Xie 4.5 Spinal System is substantially equivalent to Stryker Spine Xia Spinal System (K002858), DePuy Spine MOSS MiamiTM Spinal System (K950697 and K962628) and Medtronic Sofamor Danek CD Horizon Legacy TM (K020709). K050461 1 === P…
Depuy Motech1995—
*K962628Moss Miami Spinal System
Summary page 1
…ce Identification The Xie 4.5 Spinal System is substantially equivalent to Stryker Spine Xia Spinal System (K002858), DePuy Spine MOSS MiamiTM Spinal System (K950697 and K962628) and Medtronic Sofamor Danek CD Horizon Legacy TM (K020709). K050461 1…
Depuy, Inc.1997—
*K020709Modification to CD Horizon Spinal System
Summary page 1
…y equivalent to Stryker Spine Xia Spinal System (K002858), DePuy Spine MOSS MiamiTM Spinal System (K950697 and K962628) and Medtronic Sofamor Danek CD Horizon Legacy TM (K020709). K050461 1 fri…
Medtronic Sofamor Danek2002—

Also cleared against K002858: 5 other devices →

What descends from it? (742)

See all 742

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

NumberDeviceApplicantDecidedDescendants
K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005735
K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134
K092605Xia 4.5 Spinal SystemStryker Spine200998
K062698Trio + Spinal SystemStryker Spine200688
K103292Trio Trauma Spinal SystemStryker Corporation201185
K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384
K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410
K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075
K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K052761 (Stryker Spine, 2005) has gone furthest, with 735 descendants of its own.
  • 5 other devices also cite its predicate K002858.

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 XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion. The XIA® 4.5 Spinal System is also…

Read the full statement (113 words)

The XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The XIA® 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, non-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 K002858

5 other devices cite the same predicate.

  • K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
  • K073151Mantis Spinal SystemStryker Corp. · 2007
  • K061813Mantis Spinal SystemStryker Spine · 20062 recalls
  • K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
  • K043473Modification to Xia Spinal SystemStryker Spine · 2005

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/K050461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050461: Xia 4.5 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/K050461

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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