LogoFDA 510(k) Search
K Number
K222684
Device Name
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
Manufacturer
Stryker Spine
Date Cleared
2023-06-08

(275 days)

Product Code
NKBKWPKWQNKGNQWOWIPGM
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XIA® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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.
Device Description
The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.
More Information

XIA® 4.5 Spinal System (K172724), XIA® 3 Spinal System - Serrato (K170496), XIA® Growth Rod Conversion Set (K142114), XIA® Titanium Spinal System (K061854), MANTIS®, MANTIS® Redux, Radius®, TRIO®& TRIO® +, TRIO® Trauma, XIA®, XIA® 3 and XIA® 4.5 (K133188), ES2® Spinal System (K122845), ES2® Augmentable Spinal System (K192818), OASYS® System (K151755), NILE Proximal Fixation Spinal System (K161332), NILE Alternative Fixation Spinal System (K160208), Escalate® Laminoplasty System (K113802), EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (K181603)

Not Found

No
The document describes a spinal fixation system and its intended uses, focusing on mechanical support and fusion. There is no mention of AI or ML in the intended use, device description, or performance studies. The primary purpose of the submission is to establish MR Conditional labeling.

Yes
The text explicitly states that the various spinal systems are intended to "provide immobilization and stabilization of spinal segments" and are used to "treat" a variety of conditions such as "Degenerative Disc Disease," "Spondylolisthesis," "Trauma (i.e. fracture of dislocation)," "Spinal Stenosis," "Curvatures," "Tumor," "Pseudarthrosis," and "Failed Previous Fusion." These indications directly describe the management or treatment of a disease or condition, which aligns with the definition of a therapeutic device.

No
The device is a spinal fixation system, intended as an adjunct to fusion for treating various spinal conditions, not for diagnosing them.

No

The device description explicitly states that the subject devices consist of "multiple component spinal fixation systems," which are physical implants. The submission's primary purpose is to establish MR Conditional labeling for these implants, further confirming they are hardware devices.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The text clearly describes the XIA® 4.5 Spinal System and related systems as spinal fixation systems intended for surgical implantation to provide support and stabilization to the spine. They are used as an adjunct to fusion for various spinal conditions.
  • Lack of Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens from the patient. Its function is mechanical support within the body.

Therefore, the XIA® 4.5 Spinal System and the other listed spinal systems are implantable medical devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The XIA® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: 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 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: 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 interior/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, 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 II Titanium Spinal Systems. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the 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, 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 interior/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, 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 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 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 radies), 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, 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-S1 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™ 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 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 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 fixation of the spine to provide immobilization 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 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 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, - 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 ES2TM 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, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with the Vertaplex® HV Hiscosity 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® Augmented with the Vertaplex® HV High Viscosity Radiopague 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 of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine ( Cl to C7) and the thoracic spine (TI-T3): traumatic spinal fraumatic 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 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® 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, 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, 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.

Product codes (comma separated list FDA assigned to the subject device)

NKB, KWO, KWP, PGM, NKG, OWI, NQW

Device Description

The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spine (non-cervical, thoracolumbosacral, craniocervical junction, cervical, thoracic, lumbar, sacral), L5-S1 joint, C1 to C7, T1-T3, C3-T3

Indicated Patient Age Range

Skeletally mature patients (all systems except XIA Growth Rod Conversion Set, pediatric indications for XIA 4.5 & XIA 3), Patients with potential for additional spinal growth under 10 years of age (XIA Growth Rod Conversion Set), patients 8 years of age and older (NILE Proximal Fixation Spinal System, NILE Alternative Fixation Spinal System)

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

MR Compatibility testing per ASTM F2503 was performed. The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

XIA® 4.5 Spinal System (K172724), XIA® 3 Spinal System - Serrato (K170496), XIA® Growth Rod Conversion Set (K142114), XIA® Titanium Spinal System (K061854), MANTIS®, MANTIS® Redux, Radius®, TRIO®& TRIO® +, TRIO® Trauma, XIA®, XIA® 3 and XIA® 4.5 (K133188), ES2® Spinal System (K122845), ES2® Augmentable Spinal System (K192818), OASYS® System (K151755), NILE Proximal Fixation Spinal System (K161332), NILE Alternative Fixation Spinal System (K160208), Escalate® Laminoplasty System (K113802), EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (K181603)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 8, 2023

Stryker Spine Sierra Mertz Staff Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K222684

Trade/Device Name: 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 Fixation Spinal System, and Escalate® Laminoplasty System Regulation Number: 21 CFR 888.3070

Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWO. KWP, PGM, NKG, OWI, NOW Dated: May 11, 2023 Received: May 12, 2023

Dear Sierra Mertz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

1

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. In the background, there is a faded, light blue watermark of the letters "FDA".

Colin O'Neill. M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name XIA® 4.5 Spinal System

Indications for Use (Describe)

The XIA® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

3

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Xia® 4.5 Cortical Trajectory

Indications for Use (Describe)

The XIA® 4.5 Spinal System is interior/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 idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
----------------------------------------------
Over-The-Counter Use (21 CFR 801 Subpart C)
---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

4

510(k) Number (if known)

K222684

Device Name Xia® 3 Spinal System

Indications for Use (Describe)

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 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

5

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Xia® 3 Serrato® Spinal System

Indications for Use (Describe)

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 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

6

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Xia® Growth Rod Conversion Set

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

7

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Xia® II Spinal System

Indications for Use (Describe)

The Xia® and Xia II Titanium Spinal Systems are interior/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, 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 II Titanium Spinal Systems. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia II Titanium Spinal Systems.

Type of Use (Select one or both, as applicable)
---------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

8

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Xia® Precision System

Indications for Use (Describe)

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, 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.

Type of Use (Select one or both, as applicable)
---------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

9

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name Xia® Anterior

Indications for Use (Describe)

The Xia® Titanium Spinal System is interior/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, 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 Multi-Axial Cross Connectors are intended to be used with the other components of the Xia Titanium Spinal Systems.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

10

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name DIAPASON Spinal System

Indications for Use (Describe)

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 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 radies), 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, 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-S1 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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

11

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name Opus™ Spinal System

Indications for Use (Describe)

The OPUS™ 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

12

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Radius® Spinal System

Indications for Use (Describe)

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 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

13

510(k) Number (if known)

K222684

Device Name MANTIS® Redux Spinal System

Indications for Use (Describe)

The MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization 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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

14

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name MANTIS® Spinal System

Indications for Use (Describe)

The MANTIS® Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization 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
Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

15

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Trio® and Trio + Spinal Fixation Systems

Indications for Use (Describe)

The Stryker Spine TRIO® Spinal System is intended for posterior. noncervical pedicle and nonpedicle fixation of the spine to provide immobilization 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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16

510(k) Number (if known)

K222684

Device Name ES2TM Spinal System

Indications for Use (Describe)

The ES2™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle and nonpedicle fixation of the pine to provide immobilization 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,

  • 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 ES2TM Spinal System.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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17

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name ES2 ® Augmentable Spinal System

Indications for Use (Describe)

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, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the Vertaplex® HV Hiscosity 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® Augmented with the Vertaplex® HV High Viscosity Radiopague Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

18

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222684

Device Name OASYS® System

Indications for Use (Describe)

The Stryker Spine OASYS® System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine ( Cl to C7) and the thoracic spine (TI-T3): traumatic spinal fraumatic 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 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® 3 Systems via the saddle connector.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

19

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name NILE Proximal Fixation Spinal System

Indications for Use (Describe)

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, 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

20

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name NILE Alternative Fixation Spinal System

Indications for Use (Describe)

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, 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.

Type of Use (Select one or both, as applicable)
---------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

21

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222684

Device Name Escalate™ Laminoplasty System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

22

510(k) Summary
Submitter:Stryker Spine
2 Pearl Court
Allendale, NJ 07401
Contact Person :Name: Sierra Mertz
Phone: (484) 408-8221
Email: sierra.mertz@stryker.com
Date Prepared:May 09, 2023
Trade Name:1. XIA® 4.5 Spinal System
  1. XIA® 4.5 Cortical Trajectory
  2. XIA® 3 Spinal System
  3. Serrato® Spinal System
  4. XIA® Growth Rod Conversion Set
  5. XIA® II Spinal System
  6. XIA® Precision System
  7. XIA® Anterior
  8. Diapason® Spinal System
  9. Opus™ Spinal System
  10. Radius® Spinal System
  11. Mantis® Spinal System
  12. Mantis® Redux
  13. Trio® & Trio+ Spinal Fixation System
  14. ES2™ Spinal System
  15. ES2™ Augmentable Spinal System
  16. Oasys® Occipito-Cervico-Thoracic System
  17. Nile® Proximal Fixation Spinal System
  18. Nile® Alternative Fixation Spinal System
  19. Escalate® Laminoplasty System | |
    | Common Name: | 1. XIA® 4.5 Spinal System
    Pedicle Screw System
  20. XIA® 4.5 Cortical Trajectory
    Pedicle Screw System
  21. XIA® 3 Spinal System
    Pedicle Screw System
  22. XIA 3® Serrato® Spinal System
    Pedicle Screw System
  23. XIA® Growth Rod Conversion Set
    Growing Rod System
  24. XIA® Spinal System (Xia II)
    Pedicle Screw System
  25. XIA® Precision System
    Pedicle Screw System
  26. XIA® Anterior
    Pedicle Screw System
  27. Diapason® Spinal System
    Pedicle Screw System | |
    | 510(k) Summary | | |
    | | 10. Opus™ Spinal System
    Pedicle Screw System | |
    | | 11. Radius® Spinal System
    Pedicle Screw System | |
    | | 12. Mantis® Spinal System
    Pedicle Screw System | |
    | | 13. Mantis® Redux
    Pedicle Screw System | |
    | | 14. Trio® & Trio+ Spinal Fixation System
    Pedicle Screw System | |
    | | 15. ES2® Spinal System
    Pedicle Screw System | |
    | | 16. ES2® Augmentable Spinal System
    Pedicle Screw System | |
    | | 17. Oasys® Occipito-Cervico-Thoracic System
    Occipito-Cervico-Thoracic Screw System | |
    | | 18. Nile® Proximal Fixation Spinal System
    Bone fixation cerclage | |
    | | 19. Nile® Alternative Fixation Spinal System
    Bone fixation cerclage | |
    | | 20. Escalate® Laminoplasty System
    Spinal Interlaminal Fixation Orthosis | |
    | Classification: | Class II | |
    | Product code and
    Classification Name: | 1. XIA® 4.5 Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 2. XIA® 4.5 Cortical Trajectory
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 3. XIA® 3 Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 4. Xia® 3 Serrato® Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 5. XIA® Growth Rod Conversion Set
    PGM - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | | 6. XIA® II Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | 510(k) Summary | | |
    | | KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 7. | XIA® Precision System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 8. | XIA® Anterior
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 9. | Diapason® Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 10. | Opus Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 11. | Radius® Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050
    OSH - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | 12. | Mantis® Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050
    OSH - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | 13. | Mantis® Redux
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | 510(k) Summary | | |
    | | OSH - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | | 14. Trio® & Trio+ Spinal Fixation System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWQ - Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | OSH - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | | 15. ES2® Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 16. ES2® Augmentable Spinal System
    NKB - Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070 | |
    | | 17. Oasys® Occipito-Cervico-Thoracic System
    NKG - Posterior cervical screw system, 21 CFR §888.3075
    KWP - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | | 18. Nile® Fixation Spinal System
    OWI - Bone fixation cerclage, 21 CFR §888.3010 | |
    | | 19. Nile® Alternative Fixation Spinal System
    OWI - Bone fixation cerclage, 21 CFR §888.3010 | |
    | | 20. Escalate® Laminoplasty System
    NQW - Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
    | Predicate Devices: | Primary Predicate:
    XIA® 4.5 Spinal System (K172724) | |
    | | Additional Predicates:
    -XIA® 3 Spinal System - Serrato (K170496)
    -XIA® Growth Rod Conversion Set (K142114)
    -XIA® Titanium Spinal System (K061854)
    -MANTIS®, MANTIS® Redux, Radius®, TRIO®& TRIO® +, TRIO®
    Trauma, XIA®, XIA® 3 and XIA® 4.5 (K133188)
    -ES2® Spinal System (K122845)
    -ES2® Augmentable Spinal System (K192818)
    -OASYS® System (K151755)
    -NILE Proximal Fixation Spinal System (K161332)
    -NILE Alternative Fixation Spinal System (K160208)
    -Escalate® Laminoplasty System (K113802)
    -EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System,
    CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT
    Spinal System (K181603) | |

23

24

25

26

510(k) Summary
Device Description:The subject devices consist of a variety of multiple component spinal fixation
systems intended for use as an adjunct to fusion. These devices have been
previously cleared by FDA.
The primary purpose of this submission is to establish an MR Conditional
labeling claim for these implants.
Indications for UseXIA® 4.5 Spinal System
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 autograft and/or
allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
XIA® 4.5 Cortical Trajectory
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)
510(k) Summary
• 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 autograft and/or
allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
XIA® 3 Spinal System
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.

27

28

Pediatric pedicle screw fixation is limited to a posterior approach.

XIA 3® Serrato® Spinal Svstem

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.

XIA® Growth Rod Conversion Set

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, lifethreatening, 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.

XIA® II Spinal System

29

510(k) Summary
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.
XIA® Precision System
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 (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 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.
XIA® Anterior
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.
Diapason™ Spinal System
The 6 mm diameter rods from the DIAPASON Spinal System are intended to
be used with the components of the XIA Titanium Spinal System. As a

30

510(k) Summary
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-S1 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.
Opus™ Spinal System
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.
Radius® Spinal System
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 (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);

31

510(k) Summary
• Tumor;
• Pseudoarthrosis;
• 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.
MANTIS® Spinal System
The MANTIS® Spinal System and MANIS® 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;
• Pseudoarthrosis; and
• Failed Previous Fusion
MANTIS® Redux Spinal System
The MANTIS® Spinal System and MANIS® 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;
• Pseudoarthrosis; and
• Failed Previous Fusion
Trio / Trio + ® Spinal Fixation Systems
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:

32

510(k) Summary
• 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 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.
ES2 Spinal System
The ES2™ Spinal System is intended for percutaneous, posterior, non-cervical
pedicle and nonpedicle fixation of the spine 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,
• 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™ Spinal System.
ES2® Augmentable 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.

33

510(k) Summary

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.

Oasys® Occipito-Cervico-Thoracic System

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 ( C1 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.

Nile® Proximal Fixation Spinal Systems

The NILE Proximal Fixation Spinal System is a temporary implant 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.

34

510(k) Summary
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.

Nile® Alternative Fixation Spinal System
The NILE Alternative Fixation System is a temporary implant 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 coliosis, kyphosis, and spondylolisthesis;
  3. Spinal degenerative surgery, as an adjunct to spinal fusions.
    The NILE Alternative Fixation 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.

Escalate™ Laminoplasty System
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. |
| Summary of the
Technological
Characteristics | The subject devices possess the same technological characteristics as the
predicate devices. No changes have been made as part of this submission.
The fundamental scientific technology of the subject devices remains
unchanged. |
| Summary of the
Performance Data | MR Compatibility testing per ASTM F2503 was performed. The test results
demonstrate that the subject devices performance met the prescribed
acceptance criteria and are substantially equivalent to the predicate devices. |
| Conclusion | The subject devices possess the same intended use and technological
characteristics as the predicate devices and are therefore substantially
equivalent. |