510(k) · Cleared
ClearedXia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod
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 Jun 24, 2009 as substantially equivalent to K071373 (Stryker Spine, 2007) and 5 other predicates after a 54-day review. Its family tree reaches back 6 generations to 1995. 169 later devices descend from it.
- Decided
- Jun 24, 2009
- Review
- 54 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K950697 (1995). 39 ancestors in all. 169 later devices descend from it, 9 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 backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 1 generation backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- This deviceK091291 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 · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
Showing 5 of 169 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 169 · See all- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
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 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −1 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| 0 (this device) | 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 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 23 | 0 |
| 2024 | 24 | 0 |
| 2025 | 16 | 0 |
| 2026 | 20 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 1…[email protected] Date Summary Prepared: April 30, 2009 Predicate Devices · Stryker Spine Xia® 3 Spinal System, K071373; · Stryker Spine Xia® Spinal System, K080928;… | 2007 |
| * | K080928 | Xia Spinal System, Stainless Steel Uni-Planar ScrewsSummary page 1…te Devices · Stryker Spine Xia® 3 Spinal System, K071373; · Stryker Spine Xia® Spinal System, K080928; · Stryker Spine Xia® Spinal System, K063428;… | 2008 |
| * | K063428 | Xia Stainless Steel Spinal SystemSummary page 1…· Stryker Spine Xia® Spinal System, K080928; · Stryker Spine Xia® Spinal System, K063428; * Stryker Spine Radius® Spinal System, K062270, K082608;… | 2006 |
| * | K062270 | Radius Spinal SystemSummary page 1…· Stryker Spine Xia® Spinal System, K063428; * Stryker Spine Radius® Spinal System, K062270, K082608; E Stryker Spine Xia II Spinal System, KG 13823; and… | 2006 |
| * | K082608 | Radius Spinal System, Vitallium Rod #486613601Summary page 1…· Stryker Spine Xia® Spinal System, K063428; * Stryker Spine Radius® Spinal System, K062270, K082608; E Stryker Spine Xia II Spinal System, KG 13823; and… | 2008 |
| Kept off the family tree | K081823 | FDA’s K081823 is Masterscreen Paed - Baby Body Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…E Stryker Spine Xia II Spinal System, KG 13823; and * DePuy Spine Moss Miami Spinal System, K950697 5IL 2 V… | 1995 |
What descends from it? (169)
See all 1699 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 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K111478 | Stryker Spine Power Adaptor (Accessory Instrument) | 2011 | 34 |
| K143363 | VENUS Spinal Fixation System | 2015 | 33 |
| K120434 | Power Adaptor Instrument Accessory | 2012 | 32 |
| K192121 | Black Diamond Pedicle Screw System | 2019 | 13 |
| K213470 | PERLA® TL Posterior Osteosynthesis System | 2022 | 2 |
| K200267 | LOSPA® IS™ Spinal Fixation System | 2020 | 1 |
| K121568 | Dali Spinal Fixation System | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 5 months on median.
- 4 of the 39 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 chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as…
Read the full statement (140 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 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 05.5 mm titanium and Vitallium® 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/K091291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091291
Report an extraction error
Are you the manufacturer?
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