510(k) · Cleared
ClearedXia 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 Dec 6, 2005 as substantially equivalent to K012870 (Howmedica Osteonics Corp., 2001) and 3 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1997. 1 of the 894 devices in its family, counting itself, has a Class I recall. 889 later devices descend from it.
- Decided
- Dec 6, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K962628 (1997). 4 ancestors in all. 889 later devices descend from it, 4 citing it directly. 1 of the 894 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK962628 Moss Miami Spinal SystemDepuy, Inc. · 1997
- This deviceK053115 Xia 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 · cites it directly · 547 of its ownK061202 Revere Stabilization SystemGlobus Medical, Inc. · 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
Showing 5 of 889 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 889 · 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
- K061202Revere Stabilization SystemGlobus Medical, Inc. · 2006 · cites it directly547descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 3 generations on518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 3 generations on462descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962628 | Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| 0 (this device) | K053115 | Xia 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 | — |
| +1 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| +3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +3 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 18 | 0 |
| 2010 | 14 | 0 |
| 2011 | 18 | 0 |
| 2012 | 34 | 0 |
| 2013 | 36 | 0 |
| 2014 | 33 | 0 |
| 2015 | 41 | 0 |
| 2016 | 40 | 0 |
| 2017 | 58 | 0 |
| 2018 | 58 | 0 |
| 2019 | 53 | 0 |
| 2020 | 54 | 0 |
| 2021 | 44 | 1 |
| 2022 | 61 | 0 |
| 2023 | 88 | 0 |
| 2024 | 73 | 0 |
| 2025 | 70 | 0 |
| 2026 | 68 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012870 | Xia Stainless Steel SystemSummary page 1…21 CFR §888.3070 Predicate Device Information: Stryker Spine Xia® Stainless Steel System (K012870 & K031090) Stryker Spine Xia® Spinal System (K013823)… | 2001 |
| * | K031090 | Modification to Xia Stainless Steel SystemSummary page 1…CFR §888.3070 Predicate Device Information: Stryker Spine Xia® Stainless Steel System (K012870 & K031090) Stryker Spine Xia® Spinal System (K013823)… | 2003 |
| * | K013823 | Xia Spinal SystemSummary page 1…ss Steel System (K012870 & K031090) Stryker Spine Xia® Spinal System (K013823) DePuy Inc., Moss Miami Spinal System (K962628) Predicate Device Identificati… | 2001 |
| * | K962628 | Moss Miami Spinal SystemSummary page 1…Stryker Spine Xia® Spinal System (K013823) DePuy Inc., Moss Miami Spinal System (K962628) Predicate Device Identification The Stryker Spine Xia® Spinal Fixation System consists of Monoaxial and Polyaxial Screws, Wash… | 1997 |
What descends from it? (889)
See all 8894 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia ® Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b)who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device…
Read the full statement (276 words)
The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia ® Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b)who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia ® Spinal System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6mm diameter rods from the DIAPASON' TM Spinal System and OPUS Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia ® Titanium Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053115 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053115: Xia Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053115
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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