510(k) · Cleared
Recalled · 2009Xia 3 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 Apr 1, 2009 as substantially equivalent to K071373 (Stryker Spine, 2007) and 3 other predicates after a 135-day review. Its family tree reaches back 6 generations to 1995. 292 later devices descend from it. It has been recalled once.
- Decided
- Apr 1, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K950697 (1995). 22 ancestors in all. 292 later devices descend from it, 12 citing it directly.
- Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 2 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 1 generation backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- This deviceK083393 Xia 3 Spinal SystemStryker 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
- Descendant · cites it directly · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- Descendant · 2 generations on · 88 of its ownK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
- Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
Showing 5 of 292 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 292 · See all- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K092605Xia 4.5 Spinal SystemStryker Spine · 2009 · cites it directly98descendants
- K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · cites it directly92descendants
- K121342Xia 4.5 Spinal SystemStryker Corp. · 2012 · 2 generations on88descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −5 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | 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 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| 0 (this device) | K083393 | Xia 3 Spinal System | 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 | — |
| +1 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| +2 | K121342 | Xia 4.5 Spinal System | Stryker Corp. | 2012 | — |
| +1 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
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 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 12 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 27 | 0 |
| 2018 | 21 | 0 |
| 2019 | 14 | 0 |
| 2020 | 32 | 0 |
| 2021 | 12 | 0 |
| 2022 | 14 | 0 |
| 2023 | 35 | 0 |
| 2024 | 30 | 0 |
| 2025 | 23 | 0 |
| 2026 | 28 | 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.
Planning a device in NKB? 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? (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 |
|---|---|---|---|
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 4…[email protected] Date Summary Prepared: November 14,2008 Predicate Devices • Stryker Spine Xia® 3 Spinal System, K071373; • Stryker Spine Radius® Spinal System, K062270;… | 2007 |
| * | K062270 | Radius Spinal SystemSummary page 4…e Devices • Stryker Spine Xia® 3 Spinal System, K071373; • Stryker Spine Radius® Spinal System, K062270; • Stryker Spine Xia® II, K013823; •… | 2006 |
| * | K013823 | Xia Spinal SystemSummary page 4…373; • Stryker Spine Radius® Spinal System, K062270; • Stryker Spine Xia® II, K013823; • Moss Miami System, K950697; Description of Device Modification This 5… | 2001 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 4…pinal System, K062270; • Stryker Spine Xia® II, K013823; • Moss Miami System, K950697; Description of Device Modification This 5 IO(k) is intended to introduce an extension to the existing… | 1995 |
What descends from it? (292)
See all 29212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120270 | Venus Spinal Fixation System | 2012 | 111 |
| K092605 | Xia 4.5 Spinal System | 2009 | 98 |
| K100623 | Aesculap Implant Systems S4 Spinal System | 2010 | 92 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K121115 | M.U.S.T Pedicle Screw System | 2012 | 43 |
| K143363 | VENUS Spinal Fixation System | 2015 | 33 |
| K132878 | M.U.S.T. Extension | 2013 | 28 |
| K111940 | S 100 Pedicle Screw System | 2012 | 19 |
| K141044 | M.U.S.T. Extension | 2014 | 16 |
| K200267 | LOSPA® IS™ Spinal Fixation System | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2009 | Not classified | Z-0823-2010 | Process control | The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K120270 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 111 descendants of its own.
- 23 other devices also cite its predicate K071373.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 3 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 3 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 c\1ronic instabilities or deformities: • Degenerative disc disease (ODD) (defined as…
Read the full statement (145 words)
The Stryker Spine XIA 3 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 3 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 c\1ronic instabilities or deformities:
• Degenerative disc disease (ODD) (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 05.5 mm rods from the Stryker Spine Radius Spinal System and 06.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA 3 Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083393: Xia 3 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/K083393
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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