510(k) · Decided
DecidedXia 4.5 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 22, 2012 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) and 5 other predicates after a 49-day review. Its family tree reaches back 10 generations to 2004. 88 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 49 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K040583 (2004). 112 ancestors in all, the oldest K781443 (1978). 88 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations between
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- This deviceK121342 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
- Descendant · cites it directly · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- Descendant · 2 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
Show all 10 generations
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- This deviceK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- 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
- K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · cites it directly31descendants
- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 2 generations on15descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −7 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −5 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −1 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| +2 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| +2 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K091445 | CD Horizon Spinal SystemSummary page 3…aft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. 1.10 Predicate Devices . Medtronic Sofamor Danek, CD Horizon Spinal System, K091445 and K102807 . Synthes Spine USS Small Structure System, K994121 and K103287; . Stryker Spine XIA 4.5 Spinal System, K092605 and K… | 2010 |
| * | K102807 | CD Horizon Spinal SystemSummary page 3…llograft. Pediatric pedicle screw fixation is limited to a posterior approach. 1.10 Predicate Devices . Medtronic Sofamor Danek, CD Horizon Spinal System, K091445 and K102807 . Synthes Spine USS Small Structure System, K994121 and K103287; . Stryker Spine XIA 4.5 Spinal System, K092605 and K060361; 1.1… | 2010 |
| * | K994121 | Small Stature UssSummary page 3…ed to a posterior approach. 1.10 Predicate Devices . Medtronic Sofamor Danek, CD Horizon Spinal System, K091445 and K102807 . Synthes Spine USS Small Structure System, K994121 and K103287; . Stryker Spine XIA 4.5 Spinal System, K092605 and K060361; 1.11 Substantial Equivalence Testing performed on this… | 2000 |
| * | K103287 | Synthes 6.0 Cocr and CPT TI-3 RodsSummary page 3…erior approach. 1.10 Predicate Devices . Medtronic Sofamor Danek, CD Horizon Spinal System, K091445 and K102807 . Synthes Spine USS Small Structure System, K994121 and K103287; . Stryker Spine XIA 4.5 Spinal System, K092605 and K060361; 1.11 Substantial Equivalence Testing performed on this device indic… | 2011 |
| * | K092605 | Xia 4.5 Spinal SystemSummary page 2…through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, K060979 and K092605. _The expansion of indications for the XIA 4.5 Spinal System is propoéed for the inclusion of adolescent idiopathic scoliosis al… | 2009 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 2…l System were determined substantially equivalent through K050461 for class Il indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared thro… | 2006 |
What descends from it? (88)
See all 885 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
| K142381 | Xia 3 Spinal System | 2014 | 83 |
| K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | 2015 | 31 |
| K230482 | Swedge™ Pedicle Screw Fixation System | 2023 | 1 |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | 2024 | 0 |
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 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 16 of the 112 ancestors have a recall of any class.
- Of its descendants, K133188 (Stryker Spine, 2013) has gone furthest, with 84 descendants of its own.
- 26 other devices also cite its predicate K091445.
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® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative disc disease (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 (162 words)
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:
Degenerative disc disease (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 Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, the XIA 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA 4.5 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/K121342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121342: Xia 4.5 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/K121342
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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