510(k) · Cleared
ClearedXia 3 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 Oct 21, 2014 as substantially equivalent to K140276 (Medtronic Sofamor Danek, 2014) and 3 other predicates after a 56-day review. Its family tree reaches back 16 generations to 2004. 83 later devices descend from it.
- Decided
- Oct 21, 2014
- Review
- 56 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K040583 (2004). 170 ancestors in all, the oldest K781443 (1978). 83 later devices descend from it, 12 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- This deviceK142381 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 · cites it directly · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- Descendant · cites it directly · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 2 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · cites it directly · 12 of its ownK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- This deviceK142381 Xia 3 Spinal SystemStryker Corp. · 2014
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- 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 · cites it directly15descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · cites it directly13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 2 generations on12descendants
- K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| 0 (this device) | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| +1 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| +1 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +2 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +1 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020 | — |
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 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 19 | 0 |
| 2005 | 19 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 15 | 0 |
| 2024 | 16 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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? (4)
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 |
|---|---|---|---|
| * | K140276 | CD Horizon Spinal SystemSummary page 7…. Xia® 3 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON® Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666,… | 2014 |
| * | K113666 | Xia 3 Spinal SystemSummary page 7…CD HORIZON® Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666, 133188 2. Xia® 4.5 Spinal System… | 2012 |
| * | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Summary page 7…Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666, 133188 2. Xia® 4.5 Spinal System Primary Predicate: Medtronic So… | 2013 |
| * | K121342 | Xia 4.5 Spinal SystemSummary page 7…Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 4.5 Spinal System: K121342, 133188 Device Description 1. Xia® 3 Spinal System The Xia® 3 Spinal System is… | 2012 |
What descends from it? (83)
See all 8312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | 2015 | 31 |
| K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | 2017 | 15 |
| K192121 | Black Diamond Pedicle Screw System | 2019 | 13 |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | 2020 | 12 |
| K151216 | Everest Spinal System | 2015 | 11 |
| K172101 | ROMEO® 2 Posterior Osteosynthesis System | 2017 | 9 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System… | 2024 | 1 |
| K223096 | Dark Star Deformity Pedicle Screw System | 2023 | 1 |
| K210549 | ARx Spinal System | 2021 | 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 10 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 23 of the 170 ancestors have a recall of any class.
- Of its descendants, K152632 (Stryker Corporation, 2015) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K140276.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical 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 (as defined by back pain of…
Read the full statement (439 words)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical 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 (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm 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 posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• 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, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142381: 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/K142381
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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