510(k) · Decided
DecidedXia 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 Aug 28, 2012 as substantially equivalent to K994121 (Synthes (Usa), 2000) and 4 other predicates after a 259-day review. Its family tree reaches back 6 generations to 1995. 1 of the 296 devices in its family, counting itself, has a Class I recall. 251 later devices descend from it.
- Decided
- Aug 28, 2012
- Review
- 259 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K950697 (1995). 44 ancestors in all, the oldest K781443 (1978). 251 later devices descend from it, 21 citing it directly. 1 of the 296 devices in this family, counting this one, has a Class I recall.
- 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 deviceK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · cites it directly · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · cites it directly · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 78 of its ownK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 251 · See all- K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · cites it directly93descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · cites it directly83descendants
- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · cites it directly81descendants
- K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · 2 generations on78descendants
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) | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +1 | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
| +1 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +1 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| +2 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 11 | 0 |
| 2016 | 5 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 14 | 0 |
| 2021 | 16 | 1 |
| 2022 | 21 | 0 |
| 2023 | 34 | 0 |
| 2024 | 36 | 0 |
| 2025 | 29 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K994121 | Small Stature UssSummary page 3…nsion of these indications to a pediatric population is - not warranted. K113666 Page 3 of 3 Predicate Devices: Synthes Spine USS Small Stature System; K994121 Stryker Spine XIA® 3 Spinal System, K071373 Paradigm Spine Orthobiom Spinal System, K071668 Medtronic Sofamor Danek USA CD HORIZO… | 2000 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 3…pulation is - not warranted. K113666 Page 3 of 3 Predicate Devices: Synthes Spine USS Small Stature System; K994121 Stryker Spine XIA® 3 Spinal System, K071373 Paradigm Spine Orthobiom Spinal System, K071668 Medtronic Sofamor Danek USA CD HORIZON Spinal System, K091445 Medtronic Sofamor D… | 2007 |
| * | K071668 | Orthobiom Spinal SystemSummary page 3…3666 Page 3 of 3 Predicate Devices: Synthes Spine USS Small Stature System; K994121 Stryker Spine XIA® 3 Spinal System, K071373 Paradigm Spine Orthobiom Spinal System, K071668 Medtronic Sofamor Danek USA CD HORIZON Spinal System, K091445 Medtronic Sofamor Danek TSRH Spinal System, K111492 Substantial Eq… | 2008 |
| * | K091445 | CD Horizon Spinal SystemSummary page 3…Stature System; K994121 Stryker Spine XIA® 3 Spinal System, K071373 Paradigm Spine Orthobiom Spinal System, K071668 Medtronic Sofamor Danek USA CD HORIZON Spinal System, K091445 Medtronic Sofamor Danek TSRH Spinal System, K111492 Substantial Equivalence: . Testing performed on XIA® 3 Spinal System indica… | 2010 |
| * | K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsSummary page 3…System, K071373 Paradigm Spine Orthobiom Spinal System, K071668 Medtronic Sofamor Danek USA CD HORIZON Spinal System, K091445 Medtronic Sofamor Danek TSRH Spinal System, K111492 Substantial Equivalence: . Testing performed on XIA® 3 Spinal System indicates that the system is substantially equivalent to p… | 2011 |
What descends from it? (251)
See all 25121 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133350 | Revere Stabilization System | 2014 | 93 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K142381 | Xia 3 Spinal System | 2014 | 83 |
| K130932 | Firebird Spinal Fixation System | 2013 | 81 |
| K132603 | Apex Spine System | 2013 | 25 |
| K150417 | Astra Spine System | 2015 | 21 |
| K192121 | Black Diamond Pedicle Screw System | 2019 | 13 |
| K140678 | Cosmolock Pedicle Screw System | 2014 | 10 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K173180 | Mega Plus Spine System | 2018 | 3 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 44 ancestors have a recall of any class.
- Of its descendants, K133350 (Globus Medical, Inc., 2014) has gone furthest, with 93 descendants of its own.
- 12 other devices also cite its predicate K994121.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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 fustion 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…
Read the full statement (199 words)
The 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 fustion 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 @5.5mm rods from the Stryker Spine Radius™ Spinal System and ©6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System.
When used for po'sterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K113666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113666: Xia 3 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113666
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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