510(k) · Cleared
ClearedModification to: Xia 4.5 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, 2005 as substantially equivalent to K050461 (Stryker Spine, 2005) after an 11-day review. Its family tree reaches back 2 generations to 1995. 1 of the 741 devices in its family, counting itself, has a Class I recall. 735 later devices descend from it.
- Decided
- Oct 11, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950697 (1995). 5 ancestors in all. 735 later devices descend from it, 6 citing it directly. 1 of the 741 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 1 generation backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- This deviceK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- Descendant · cites it directly · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · 2 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- Descendant · 3 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 3 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 430 of its ownK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
Showing 5 of 735 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 735 · See all- K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · cites it directly734descendants
- K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 2 generations on710descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 3 generations on518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 3 generations on462descendants
- K071373Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · 2 generations on430descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −1 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| 0 (this device) | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| +1 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| +2 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| +3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +3 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +2 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 11 | 0 |
| 2010 | 10 | 0 |
| 2011 | 12 | 0 |
| 2012 | 29 | 0 |
| 2013 | 31 | 0 |
| 2014 | 26 | 0 |
| 2015 | 37 | 0 |
| 2016 | 33 | 0 |
| 2017 | 54 | 0 |
| 2018 | 51 | 0 |
| 2019 | 46 | 0 |
| 2020 | 46 | 0 |
| 2021 | 36 | 1 |
| 2022 | 45 | 0 |
| 2023 | 69 | 0 |
| 2024 | 64 | 0 |
| 2025 | 60 | 0 |
| 2026 | 55 | 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.
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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K050461 | Xia 4.5 Spinal SystemSummary page 1…pinal Interlaminal 87 KWQ: Appliance, Fixation, Spinal, Intervertebral Body 87 MNH: Spondylolisthesis Spinal Fixation System 87 MNT: Orthosis, Spinal. Pedicle Fixation K050461 - Xia" 4.5 Spinal System Ko s 27 P.fie 2/2 Predicate Device Identification The Stryker Spine Xia™ 4.5 Spinal Syst… | 2005 |
What descends from it? (735)
See all 7356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060361 | Xia Spinal System, Xia 4.5 Spinal System | 2006 | 734 |
| K060748 | Modification to Xia 4.5 Spinal System | 2006 | 134 |
| K103292 | Trio Trauma Spinal System | 2011 | 85 |
| K140678 | Cosmolock Pedicle Screw System | 2014 | 10 |
| K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle… | 2014 | 3 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | 2016 | 2 |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K060361 (Stryker Spine, 2006) has gone furthest, with 734 descendants of its own.
- 11 other devices also cite its predicate K050461.
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 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 (135 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.
The XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052761: Modification to: 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/K052761
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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