# K122845: ES2 Spinal System Model 48280XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Dec 7, 2012 after 81 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). 45 ancestors in all.
28 later devices descend from it; 7 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092631: Mantis Redux Spinal System, Stryker Spine (2009) Summary page 1.
- K102235: Mantis Spinal System & Mantis Redux Spinal System, Stryker Spine (2010) Summary page 1.

## Most influential descendants
- K140400: ES2 Neuromonitoring Accessory Instruments (2014), 9 descendants of its own
- K192818: Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (2020), 8 descendants of its own
- K171807: ES2 Neuromonitoring Accessory Instruments (2017), 7 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own

## Indications for use
The ES2 TM Spinal System is intended for percutaneous, posterior, non-cervical 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. The Titanium and Vitallium® rods from the Stryker Spine RADIUS®, MANTIS® and MANTIS® Redux Spinal Systems are intended to be used with the other components of the ES2 TM Spinal System. 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 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 System, MANTIS® Redux Spinal System and the ES2 TM Spinal System. 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 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 (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 MANTIS® Spinal System, MANTIS® Redux Spinal System and ES2 TM 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.

Source page: https://510kreport.com/device/K122845
Methodology: https://510kreport.com/methodology