510(k) · Cleared
ClearedPower Adaptor Instrument Accessory
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 Mar 8, 2012 as substantially equivalent to K111478 (Stryker Corporation, 2011) and 6 other predicates after a 24-day review. Its family tree reaches back 9 generations to 1995. 32 later devices descend from it.
- Decided
- Mar 8, 2012
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K950697 (1995). 55 ancestors in all, the oldest K943323 (1994). 32 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- 2 generations backK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
- 1 generation backK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011
- This deviceK120434 Power Adaptor Instrument AccessoryStryker Corp. · 2012
- 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 · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 9 of its ownK172724 XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017
- Descendant · 3 generations on · 8 of its ownK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 4 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 3 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- 2 generations backK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
- 1 generation backK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011
- This deviceK120434 Power Adaptor Instrument AccessoryStryker Corp. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · 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 · 2 generations on15descendants
- K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · 2 generations on12descendants
- K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 2 generations on9descendants
- K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −4 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −3 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| −2 | K092605 | Xia 4.5 Spinal System | Stryker Spine | 2009 | — |
| −1 | K111478 | Stryker Spine Power Adaptor (Accessory Instrument) | Stryker Corporation | 2011 | — |
| 0 (this device) | K120434 | Power Adaptor Instrument Accessory | Stryker Corp. | 2012 | — |
| +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 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | — |
| +3 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K111478 | Stryker Spine Power Adaptor (Accessory Instrument)Summary page 4…Inclusion of Adaptor Instrumnt Accessory' Page 4 of 5 1.9 Predicate Devices " Stryker Spine RemB Universal Driver, Power Adaptor, K111478 * Stryker Spine XIA Spinal Systems, K060361; * Stryker Spine XIA 3 Spinal System, K09 1291; * St… | 2011 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 4…Page 4 of 5 1.9 Predicate Devices " Stryker Spine RemB Universal Driver, Power Adaptor, K111478 * Stryker Spine XIA Spinal Systems, K060361; * Stryker Spine XIA 3 Spinal System, K09 1291; * Stryker Spine XIA 4.5 Spinal System, K092605; "… | 2006 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodSummary page 4…Stryker Spine RemB Universal Driver, Power Adaptor, K111478 * Stryker Spine XIA Spinal Systems, K060361; * Stryker Spine XIA 3 Spinal System, K09 1291; * Stryker Spine XIA 4.5 Spinal System, K092605; " Stryker Spine RADIUS Spinal System, KIOI 144; *… | 2009 |
| * | K092605 | Xia 4.5 Spinal SystemSummary page 4…11478 * Stryker Spine XIA Spinal Systems, K060361; * Stryker Spine XIA 3 Spinal System, K09 1291; * Stryker Spine XIA 4.5 Spinal System, K092605; " Stryker Spine RADIUS Spinal System, KIOI 144; * Stryker Spine MANTIS Spinal System, K102235; "… | 2009 |
| * | K101144 | Modification to:Radius Spinal System | 2010 |
| * | K102235 | Mantis Spinal System & Mantis Redux Spinal SystemSummary page 4…1; * Stryker Spine XIA 4.5 Spinal System, K092605; " Stryker Spine RADIUS Spinal System, KIOI 144; * Stryker Spine MANTIS Spinal System, K102235; " Stryker Instruments CD3 Cordless Driver System, K943323. 1.10 Summary of Technological Characteristics A Ris… | 2010 |
| * | K943323 | Stryker Surgical Instruments and AccessoriesSummary page 4…Stryker Spine RADIUS Spinal System, KIOI 144; * Stryker Spine MANTIS Spinal System, K102235; " Stryker Instruments CD3 Cordless Driver System, K943323. 1.10 Summary of Technological Characteristics A Risk Assessment was conducted using both the RemB Universal Driver (corde… | 1994 |
What descends from it? (32)
See all 323 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 17 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 7 of the 55 ancestors have a recall of any class.
- Of its descendants, K152632 (Stryker Corporation, 2015) has gone furthest, with 31 descendants of its own.
- 3 other devices also cite its predicate K111478.
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?
Intended Use: 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 Reamner and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemBl Universal Driver. When the power adaptors are attached, the C03 Cordless Driver 3 and RemB Universal Driver provide power (corded…
Read the full statement (406 words)
Intended Use:
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 Reamner and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemBl Universal Driver. When the power adaptors are attached, the C03 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 skeletally mature non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia Spinal Systems (Xia Stainless Steel, Xia 11, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.
Indications for Use:
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 (DOD) (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 4.5, 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 3, XIA 4.5, 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 (OD) (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 MANTIS® Spinal System and MANTIS® Redux 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/K120434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120434: Power Adaptor 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/K120434
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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