510(k) · Cleared
Recalled · 2012Stryker Spine Xia Iii Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 27, 2007 as substantially equivalent to K060361 (Stryker Spine, 2006) and 4 other predicates after a 103-day review. Its family tree reaches back 5 generations to 1995. 1 of the 452 devices in its family, counting itself, has a Class I recall. 430 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2007
- Review
- 103 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K950697 (1995). 21 ancestors in all. 430 later devices descend from it, 24 citing it directly. 1 of the 452 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- This deviceK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007
- Descendant · cites it directly · 292 of its ownK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- Descendant · cites it directly · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · cites it directly · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
- Descendant · cites it directly · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 98 of its ownK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
Showing 5 of 430 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 430 · See all- K083393Xia 3 Spinal SystemStryker Spine · 2009 · cites it directly292descendants
- K113666Xia 3 Spinal SystemStryker Spine · 2012 · cites it directly251descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · cites it directly169descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K092605Xia 4.5 Spinal SystemStryker Spine · 2009 · cites it directly98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| 0 (this device) | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | — |
| +1 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| +1 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +1 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
| +1 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K092605 | Xia 4.5 Spinal System | Stryker Spine | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 13 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 20 | 0 |
| 2016 | 14 | 0 |
| 2017 | 36 | 0 |
| 2018 | 29 | 0 |
| 2019 | 24 | 0 |
| 2020 | 34 | 0 |
| 2021 | 24 | 1 |
| 2022 | 26 | 0 |
| 2023 | 49 | 0 |
| 2024 | 46 | 0 |
| 2025 | 39 | 0 |
| 2026 | 45 | 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.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 1…s 21 CFR 888.3050 Product Code NKB, MNH, MNI, and KWP Predicate Devices Stryker Spine Xia® Spinal Systems: 5 10(k) #K060361, K060979, and #K013823, Stryker Spine RadiusTM Spinal System: 510(k) # K062… | 2006 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…888.3050 Product Code NKB, MNH, MNI, and KWP Predicate Devices Stryker Spine Xia® Spinal Systems: 5 10(k) #K060361, K060979, and #K013823, Stryker Spine RadiusTM Spinal System: 510(k) # K062270, DePu… | 2006 |
| * | K013823 | Xia Spinal SystemSummary page 1…duct Code NKB, MNH, MNI, and KWP Predicate Devices Stryker Spine Xia® Spinal Systems: 5 10(k) #K060361, K060979, and #K013823, Stryker Spine RadiusTM Spinal System: 510(k) # K062270, DePuy's Moss Miami… | 2001 |
| * | K062270 | Radius Spinal SystemSummary page 1…Spine Xia® Spinal Systems: 5 10(k) #K060361, K060979, and #K013823, Stryker Spine RadiusTM Spinal System: 510(k) # K062270, DePuy's Moss Miami Spinal System: 5 10(k) #K950697. Stryker Spine Xia® III Spinal Sys… | 2006 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…9, and #K013823, Stryker Spine RadiusTM Spinal System: 510(k) # K062270, DePuy's Moss Miami Spinal System: 5 10(k) #K950697. Stryker Spine Xia® III Spinal System Traditional 5 10(k) Premarket Notification De… | 1995 |
What descends from it? (430)
See all 43024 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083393 | Xia 3 Spinal System | 2009 | 292 |
| K113666 | Xia 3 Spinal System | 2012 | 251 |
| K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | 2009 | 169 |
| K120270 | Venus Spinal Fixation System | 2012 | 111 |
| K092605 | Xia 4.5 Spinal System | 2009 | 98 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K143363 | VENUS Spinal Fixation System | 2015 | 33 |
| K132603 | Apex Spine System | 2013 | 25 |
| K150417 | Astra Spine System | 2015 | 21 |
| K140678 | Cosmolock Pedicle Screw System | 2014 | 10 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2012 | Not classified | Z-1706-2012 | Mixed-up of materials/components | Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery. |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K083393 (Stryker Spine, 2009) has gone furthest, with 292 descendants of its own.
- 18 other devices also cite its predicate K060361.
How does its category compare?
All NKB devicesNKB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc disease (DDD)…
Read the full statement (144 words)
The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
* 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 05.5mm rods from the Stryker Spine RadiusM Spinal System and 06.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of XIA® III Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071373: Stryker Spine Xia Iii 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/K071373
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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