# K111478: Stryker Spine Power Adaptor (Accessory Instrument)

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Aug 4, 2011 after 69 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K950697 (1995). 53 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 1.
- K092605: Xia 4.5 Spinal System, Stryker Spine (2009) Summary page 1.
- K101144: Modification to:Radius Spinal System, Stryker Spine (2010) Summary page 1.
- K102235: Mantis Spinal System & Mantis Redux Spinal System, Stryker Spine (2010) Summary page 1.
- K101168: Legend Power Adapter Model: 6475000, Medtronic Sofamor Danek (2010)

## Most influential descendants
- K120434: Power Adaptor Instrument Accessory (2012), 32 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own
- K163604: SeaSpine® Daytona® Small Stature Spinal System (2017), 12 descendants of its own
- K172724: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory (2017), 9 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111478
Methodology: https://510kreport.com/methodology