510(k) · Cleared
ClearedXIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 2, 2015 as substantially equivalent to K142381 (Stryker Corp., 2014) and 8 other predicates after a 78-day review. Its family tree reaches back 17 generations to 2004. 31 later devices descend from it.
- Decided
- Dec 2, 2015
- Review
- 78 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 17 generations to K040583 (2004). 175 ancestors in all, the oldest K781443 (1978). 31 later devices descend from it, 6 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- This deviceK152632 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 · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 9 of its ownK172724 XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017
- Descendant · 2 generations on · 8 of its ownK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 3 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- This deviceK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · cites it directly15descendants
- K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · cites it directly12descendants
- K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017 · cites it directly9descendants
- K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on8descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −3 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −1 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| 0 (this device) | 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 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | — |
| +2 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | — |
| +3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 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 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (9)
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 |
|---|---|---|---|
| * | K142381 | Xia 3 Spinal SystemSummary page 6…Predicate ® • Stryker Spine XIA 4.5 Spinal System, K142381 Additional Predicates… | 2014 |
| * | K140276 | CD Horizon Spinal SystemSummary page 6…Predicates ® • Stryker Spine XIA 4.5 Spinal System (K140276, K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709… | 2014 |
| * | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Summary page 6…Predicates ® • Stryker Spine XIA 4.5 Spinal System (K140276, K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709 • DePuy Motech… | 2013 |
| * | K121342 | Xia 4.5 Spinal SystemSummary page 6…edicates ® • Stryker Spine XIA 4.5 Spinal System (K140276, K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709 • DePuy Motech Moss Miam… | 2012 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 6…® • Stryker Spine XIA 4.5 Spinal System (K140276, K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709 • DePuy Motech Moss Miami, K95069… | 2006 |
| * | K020709 | Modification to CD Horizon Spinal SystemSummary page 6…• Stryker Spine XIA 4.5 Spinal System (K140276, K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709 • DePuy Motech Moss Miami, K950697 • Stryker Spine RADIUS® Spinal System, K… | 2002 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 6…K133188, K121342, K060361) • Medtronic CD Legacy (Horizon), K020709 • DePuy Motech Moss Miami, K950697 • Stryker Spine RADIUS® Spinal System, K101144 • Stryker Spine XIA® 3 Spina… | 1995 |
| * | K101144 | Modification to:Radius Spinal SystemSummary page 6…Medtronic CD Legacy (Horizon), K020709 • DePuy Motech Moss Miami, K950697 • Stryker Spine RADIUS® Spinal System, K101144 • Stryker Spine XIA® 3 Spinal System, K142381 2. The Stryker Spine Power Adapto… | 2010 |
| * | K120434 | Power Adaptor Instrument AccessorySummary page 6…Additional Predicate • Stryker Spine Power Adaptor Instrument Accessory, K120434 Device Description 1. The XIA® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduct… | 2012 |
What descends from it? (31)
See all 316 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | 2017 | 15 |
| K163604 | SeaSpine® Daytona® Small Stature Spinal System | 2017 | 12 |
| K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | 2017 | 9 |
| K200666 | Stryker Xia 3 Power Adaptor | 2020 | 3 |
| K202528 | Cannulated Power Driver Attachment | 2020 | 0 |
| K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | 2017 | 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 11 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 24 of the 175 ancestors have a recall of any class.
- Of its descendants, K170496 (Stryker Corporation, 2017) has gone furthest, with 15 descendants of its own.
- 11 other devices also cite its predicate K142381.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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, 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) *…
Read the full statement (815 words)
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral 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.
Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.
Indications for Use (Power):
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion 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; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are 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 (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 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.
The MANTIS® Spinal System, MANTIS® Redux Spinal System, and ES2® Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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.
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/K152632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152632
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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