510(k) · Cleared
ClearedXia Titanium Spinal System and Xia Stainless Steel 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 Jul 27, 2006 as substantially equivalent to K060361 (Stryker Spine, 2006) and 5 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1995. 216 later devices descend from it.
- Decided
- Jul 27, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K950697 (1995). 13 ancestors in all. 216 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 3 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 1 generation backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- This deviceK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- Descendant · cites it directly · 204 of its ownK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- Descendant · 2 generations on · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
- Descendant · 3 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 110 of its ownK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- Descendant · 2 generations on · 109 of its ownK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 216 · See all- K063428Xia Stainless Steel Spinal SystemStryker Spine · 2006 · cites it directly204descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · 2 generations on169descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 3 generations on111descendants
- K092631Mantis Redux Spinal SystemStryker Spine · 2009 · 2 generations on110descendants
- K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010 · 2 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −3 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | 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 |
| 0 (this device) | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| +1 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| +2 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
| +3 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| +2 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 3 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 7 | 0 |
| 2022 | 15 | 0 |
| 2023 | 27 | 0 |
| 2024 | 25 | 0 |
| 2025 | 20 | 0 |
| 2026 | 22 | 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? (6)
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…one: (201) 760-8145 Fax: (201) 760-8345 Email: [email protected] Date Summary Prepared: June 29, 2006 Predicate Devices Stryker Spine Xia® Titanium Spine System K060361, K013823, K002858, K022160. Line Extension to the Xia® Titanium Spinal System and Xia® Stainless Steel Spinal Sys… | 2006 |
| * | K013823 | Xia Spinal SystemSummary page 1…) 760-8145 Fax: (201) 760-8345 Email: [email protected] Date Summary Prepared: June 29, 2006 Predicate Devices Stryker Spine Xia® Titanium Spine System K060361, K013823, K002858, K022160. Line Extension to the Xia® Titanium Spinal System and Xia® Stainless Steel Spinal Systcm Desc… | 2001 |
| * | K002858 | Xia Spine SystemSummary page 1…5 Fax: (201) 760-8345 Email: [email protected] Date Summary Prepared: June 29, 2006 Predicate Devices Stryker Spine Xia® Titanium Spine System K060361, K013823, K002858, K022160. Line Extension to the Xia® Titanium Spinal System and Xia® Stainless Steel Spinal Systcm Description o… | 2000 |
| * | K022160 | Xia Spinal SystemSummary page 1…01) 760-8345 Email: [email protected] Date Summary Prepared: June 29, 2006 Predicate Devices Stryker Spine Xia® Titanium Spine System K060361, K013823, K002858, K022160. Line Extension to the Xia® Titanium Spinal System and Xia® Stainless Steel Spinal Systcm Description of Device… | 2002 |
| * | K031090 | Modification to Xia Stainless Steel SystemSummary page 2…ed Use Summary of the Technological Characteristics Special 510(k) Premarket Notification Koo !85Y P9y 2oF3 Stryker Spine Xia® Stainless Steel Spine System ' K060361, K031090, K012870. This 510(k) is intended to introduce an extension to the existing Xia®Titanium Spinal System and Xia®Stainless Steel S… | 2003 |
| * | K012870 | Xia Stainless Steel SystemSummary page 2…ummary of the Technological Characteristics Special 510(k) Premarket Notification Koo !85Y P9y 2oF3 Stryker Spine Xia® Stainless Steel Spine System ' K060361, K031090, K012870. This 510(k) is intended to introduce an extension to the existing Xia®Titanium Spinal System and Xia®Stainless Steel Spinal Sys… | 2001 |
What descends from it? (216)
See all 2164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K063428 (Stryker Spine, 2006) has gone furthest, with 204 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.
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 Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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…
Read the full statement (110 words)
The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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 6 mm diameter rods from the DIAPASON™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061854: Xia Titanium Spinal System and Xia Stainless Steel Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061854
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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