510(k) · Cleared
ClearedStryker Spine Power Adaptor (Accessory Instrument)
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 Aug 4, 2011 as substantially equivalent to K060361 (Stryker Spine, 2006) and 5 other predicates after a 69-day review. Its family tree reaches back 8 generations to 1995. 34 later devices descend from it.
- Decided
- Aug 4, 2011
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K950697 (1995). 53 ancestors in all. 34 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 2 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- 1 generation backK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
- This deviceK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011
- Descendant · cites it directly · 32 of its ownK120434 Power Adaptor Instrument AccessoryStryker Corp. · 2012
- Descendant · 2 generations on · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- Descendant · 3 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- Descendant · 3 generations on · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 3 generations on · 9 of its ownK172724 XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K120434Power Adaptor Instrument AccessoryStryker Corp. · 2012 · cites it directly32descendants
- K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · 2 generations on31descendants
- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 3 generations on15descendants
- K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · 3 generations on12descendants
- K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −2 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| −1 | K092605 | Xia 4.5 Spinal System | Stryker Spine | 2009 | — |
| 0 (this device) | K111478 | Stryker Spine Power Adaptor (Accessory Instrument) | Stryker Corporation | 2011 | — |
| +1 | K120434 | Power Adaptor Instrument Accessory | Stryker Corp. | 2012 | — |
| +2 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| +3 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| +3 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| +3 | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 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? (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 |
|---|---|---|---|
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 1…[email protected] Date Summary Prepared: August 3, 2011 Predicate Devices * Stryker Spine XIA Spinal Systems, K06036 1; E Stryker Spine XIA 3 Spinal System, K09129 1;… | 2006 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodSummary page 1…* Stryker Spine XIA Spinal Systems, K06036 1; E Stryker Spine XIA 3 Spinal System, K09129 1; Stryker Spine XIA 4.5 Spinal System, K(092605;… | 2009 |
| * | K092605 | Xia 4.5 Spinal SystemSummary page 1…E Stryker Spine XIA 3 Spinal System, K09129 1; Stryker Spine XIA 4.5 Spinal System, K(092605; *Stryker Spine RADIUS Spinal System, KI101144;… | 2009 |
| * | K101144 | Modification to:Radius Spinal SystemSummary page 1…Stryker Spine XIA 4.5 Spinal System, K(092605; *Stryker Spine RADIUS Spinal System, KI101144; * Stryker Spine MANTIS Spinal System, K 102235;… | 2010 |
| * | K102235 | Mantis Spinal System & Mantis Redux Spinal SystemSummary page 1…*Stryker Spine RADIUS Spinal System, KI101144; * Stryker Spine MANTIS Spinal System, K 102235; *Medtronic LEGEND Power Adaptor, KI10I1168; Line Extensio… | 2010 |
| * | K101168 | Legend Power Adapter Model: 6475000 | 2010 |
What descends from it? (34)
See all 344 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 3 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 53 ancestors have a recall of any class.
- Of its descendants, K120434 (Stryker Corp., 2012) has gone furthest, with 32 descendants of its own.
- 18 other devices also cite its predicate K060361.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws. Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally…
Read the full statement (360 words)
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered instrumentation. The systems include 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.
The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (ODD) (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, XIA® 3, Radius® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical 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 (ODD) (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; Pseudoartosis; and Failed previous fusion.
The MANTIS® Spinal System and MANTIS®D Redlux 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 lordlosis); tumor; Pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111478 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111478: Stryker Spine Power Adaptor (Accessory Instrument).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111478
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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