# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Jun 8, 2023 after 275 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: 24 generations back to K853033 (1985). 601 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 606 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172724: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory, Stryker Corporation (2017) Summary page 26.
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory, Stryker Corporation (2017) Summary page 26.
- K142114: Xia® Growth Rod Conversion Set, Stryker Corporation (2014) Summary page 26.
- K061854: Xia Titanium Spinal System and Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 26.
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal, Stryker Spine (2013) Summary page 26.
- K122845: ES2 Spinal System Model 48280XXXX, Stryker Spine (2012) Summary page 26.
- K192818: Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System, Stryker Corporation (2020) Summary page 26.
- K151755: OASYS (r) System, Stryker Corporation (2015) Summary page 26.
- K161332: NILE Proximal Fixation Spinal System, K2m, Inc. (2017) Summary page 26.
- K160208: NILE Alternative Fixation Spinal System, K2m, Inc. (2016) Summary page 26.
- K113802: Escalate Laminoplasty System, Stryker Spine (2012) Summary page 26.
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System, K2m, Inc. (2018) Summary page 26.

## Most influential descendants
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own
- K240872: Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (2024), 1 descendant of its own
- K253545: Vulcan Spinal System (2026), 0 descendants of its own
- K241863: Erisma® Lp Spinal Fixation System; Erisma® LP MIS (2024), 0 descendants of its own

## Indications for use
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral 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. 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 autogra:ft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The XIA® 4.5 Spinal System is intended for anterior/anteriolateral 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. 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 autogra:ft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using auto graft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • 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 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. 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. The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using auto graft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • 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 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. 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. he Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples. The Xia® and Xia II Titanium Spinal Systems are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia and Xia II Titanium Spinal Systems. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia and Xia II Titanium Spinal Systems. The Xia® Titanium Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the XiaTitanium Spinal Systems. The Xia® Titanium Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia Titanium Spinal Systems. The 6mm diameter rods from the DIAPASON Spinal System are intended to be used with the components of the XIA Titanium Spinal System. As a posterior, non-pedicle screw system of the T4-S2 spine, the Diapason Spinal system is indicated for long and short curve scoliosis, vertebral fracture or dislocation, spondylolisthesis, degenerative-disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), previously failed fusion and spinal tumor. When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the Diapason Spinal system is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, the Diapason Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) at the L5-Sl joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass. The OPUS™ Spinal System is intended for posterior, noncervical 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: 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 OPUS™ Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The OPUS Spinal System is also intended to be used in conjunction with the Multi-Acis Cross Connectors. The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® 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 (DOD) ( defined as back pain of discogenic origin with degeneration of the disc confimned by history and radiographic studies); • Spondylolisthesis; • Trauma (i.e. fracture or dislocation); • Spinal Stenosis; • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); • Tumor; • Pseudoarthorisis; • and Failed Previous Fusion The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the 05.5mm to 06.0mm Radius® rod-to-rod connector. The 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; • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); • Tumor; • Pseudoarthorisis; and • Failed Previous Fusion The MANTIS® 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; • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); • Tumor; • Pseudoarthorisis; and • Failed Previous Fusion The Stryker Spine TRIO® Spinal System is intended for posterior. noncervical pedicle and nonpedicle 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 (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; • Pseudoarthorisis; • and Failed Previous Fusion The TRIO® Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods. and the Multi-Axis Cross Connectors. The TRIO®+ Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors. The ES2™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle and nonpedicle fixation of the pine to provide immobilization and stabilization of spinal segment 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, • Pseudarthrosis, 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™ Spinal System. When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation 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, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine ( C 1 to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods. The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via the saddle connector. The NILE Proximal Fixation Spinal System are temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The NILE Proximal Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants. The NILE Alternative Fixation Spinal System are temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants. The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.

Source page: https://510kreport.com/device/K222684
Methodology: https://510kreport.com/methodology