510(k) · Cleared
ClearedStryker Xia 3 Power Adaptor
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 Apr 23, 2020 as substantially equivalent to K172724 (Stryker Corporation, 2017) and 5 other predicates after a 41-day review. Its family tree reaches back 19 generations to 2004. 3 later devices descend from it.
- Decided
- Apr 23, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K040583 (2004). 179 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 1 generation backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- This deviceK200666 Stryker Xia 3 Power AdaptorStryker Spine · 2020
- Descendant · cites it directly · 1 of its ownK233300 POWEReam 1/4 DriveStryker Instruments · 2023
- Descendant · 2 generations on · 0 of its ownK240526 POWEReam Xia/SerratoStryker Instruments · 2024
- Descendant · cites it directly · 0 of its ownK202528 Cannulated Power Driver AttachmentK2m, Inc. · 2020
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 5 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 4 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 1 generation backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- This deviceK200666 Stryker Xia 3 Power AdaptorStryker Spine · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −5 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −4 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −3 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −2 | 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 |
| 0 (this device) | K200666 | Stryker Xia 3 Power Adaptor | Stryker Spine | 2020 | — |
| +1 | K233300 | POWEReam 1/4 Drive | Stryker Instruments | 2023 | — |
| +2 | K240526 | POWEReam Xia/Serrato | Stryker Instruments | 2024 | — |
| +1 | K202528 | Cannulated Power Driver Attachment | K2m, Inc. | 2020 | — |
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 | 4 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument AccessorySummary page 5…olumbosacral Pedicle Screw System Regulation Number: 888.3070 Product Code: NKB Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 5… | 2017 |
| * | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessorySummary page 5…888.3070 Product Code: NKB Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 510(k) premarket notification is to expand the intended… | 2017 |
| * | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessorySummary page 5…0 Product Code: NKB Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 510(k) premarket notification is to expand the intended use of th… | 2015 |
| * | K120434 | Power Adaptor Instrument AccessorySummary page 5…Code: NKB Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 510(k) premarket notification is to expand the intended use of the Xia 3… | 2012 |
| * | K122845 | ES2 Spinal System Model 48280XXXXSummary page 5…NKB Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 510(k) premarket notification is to expand the intended use of the Xia 3… | 2012 |
| * | K111478 | Stryker Spine Power Adaptor (Accessory Instrument)Summary page 5…B Predicate Device: Primary Predicate is the most recently cleared system K172724. Additional Predicate: K170496, K152632, K120434, K122845, K111478 Device Description: This special 510(k) premarket notification is to expand the intended use of the Xia 3… | 2011 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 25 of the 179 ancestors have a recall of any class.
- Of its descendants, K233300 (Stryker Instruments, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K172724.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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® 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.…
Read the full statement (548 words)
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.
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.
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 as stated in the FDA summary.
https://510kreport.com/device/K200666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200666: Stryker Xia 3 Power Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200666
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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