510(k) · Cleared
ClearedXia Titanium and 4.5 Spinal Systems
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 May 19, 2006 as substantially equivalent to K060361 (Stryker Spine, 2006) and 2 other predicates after a 39-day review. Its family tree reaches back 4 generations to 1995. 1 of the 730 devices in its family, counting itself, has a Class I recall. 710 later devices descend from it.
- Decided
- May 19, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K950697 (1995). 19 ancestors in all. 710 later devices descend from it, 12 citing it directly. 1 of the 730 devices in this family, counting this one, has a Class I recall.
- 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 deviceK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- Descendant · cites it directly · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 430 of its ownK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- Descendant · 2 generations on · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 292 of its ownK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
Showing 5 of 710 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 710 · See all- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants
- K071373Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · cites it directly430descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · 2 generations on337descendants
- K083393Xia 3 Spinal SystemStryker Spine · 2009 · 2 generations on292descendants
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) | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| +1 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +1 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| +2 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| +2 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 8 | 0 |
| 2011 | 12 | 0 |
| 2012 | 28 | 0 |
| 2013 | 30 | 0 |
| 2014 | 25 | 0 |
| 2015 | 35 | 0 |
| 2016 | 31 | 0 |
| 2017 | 54 | 0 |
| 2018 | 50 | 0 |
| 2019 | 46 | 0 |
| 2020 | 46 | 0 |
| 2021 | 35 | 1 |
| 2022 | 45 | 0 |
| 2023 | 69 | 0 |
| 2024 | 64 | 0 |
| 2025 | 60 | 0 |
| 2026 | 55 | 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? (3)
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 2…== Line Extension to the XIa* Titanium and Xia' 4.5 Spinal Systems Special 510(k) Premnarket Notification Predicate Device Information: K060361 - Stryker Spine Xia® Spinal System and Stryker Spine Xia 4.5 Spinal System K020709- Medtronic Sofamor Danek CD Legacy 4… | 2006 |
| * | K020709 | Modification to CD Horizon Spinal SystemSummary page 2…remnarket Notification Predicate Device Information: K060361 - Stryker Spine Xia® Spinal System and Stryker Spine Xia 4.5 Spinal System K020709- Medtronic Sofamor Danek CD Legacy 4.5 Spinal System K043488 - Medtronic Sofamor Danek CD Horizon® Spinal System Pred… | 2002 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 2…K060361 - Stryker Spine Xia® Spinal System and Stryker Spine Xia 4.5 Spinal System K020709- Medtronic Sofamor Danek CD Legacy 4.5 Spinal System K043488 - Medtronic Sofamor Danek CD Horizon® Spinal System Predicate Device Identification The Stryker Spine Xia® Spinal System consis… | 2005 |
What descends from it? (710)
See all 71012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082942 | Modfication to: Expedium Spine System | 2008 | 518 |
| K090230 | Expedium Spine System | 2009 | 462 |
| K071373 | Stryker Spine Xia Iii Spinal System | 2007 | 430 |
| K082608 | Radius Spinal System, Vitallium Rod #486613601 | 2008 | 200 |
| K092605 | Xia 4.5 Spinal System | 2009 | 98 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K072605 | Malibu Spinal System | 2007 | 67 |
| K122571 | Malibu Spinal System with the Daytona Deformity System | 2012 | 62 |
| K062670 | Vertiflex Spinal Screw System | 2007 | 12 |
| K072426 | Atlas Spine Pedicle Screw System | 2007 | 5 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 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.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K082942 (Depuy Spine, Inc., 2008) has gone furthest, with 518 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 and Xia 4.5 Spinal System are 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…
Read the full statement (115 words)
The Xia® Spinal System and Xia 4.5 Spinal System are 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 as stated in the FDA summary.
https://510kreport.com/device/K060979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060979: Xia Titanium and 4.5 Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060979
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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