XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory

K172724 · Stryker Corporation · NKB · Oct 10, 2017 · Orthopedic

Device Facts

• Record ID: K172724
• Device Name: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
• Applicant: Stryker Corporation
• Product Code: NKB · Orthopedic
• Decision Date: Oct 10, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The XIA® 4.5 Spinal System is intended for 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.

Device Story

System comprises monoaxial, polyaxial, and cortical trajectory (CT) bone screws, hooks, staples, and connectors for spinal fixation. Used in OR by surgeons to stabilize spinal segments as adjunct to fusion. Power adaptor accessory facilitates screw insertion by providing mechanical interface between power drivers (CD3 Cordless Driver 3, RemB Universal Driver) and screwdriver instruments. Adaptor allows use of powered instrumentation for screw rotation. System components are implanted to provide immobilization; clinical benefit derived from stabilization of spinal segments during fusion process.

Clinical Evidence

Bench testing only. Engineering analysis performed to evaluate impact of new components on system performance; no new clinical data provided.

Technological Characteristics

System components include bone screws, hooks, staples, and connectors. Power adaptor acts as mechanical interface for powered drivers. Materials are consistent with existing predicate system. Manual or powered (corded/cordless) insertion. Non-sterile/sterilizable components.

Indications for Use

Indicated for skeletally mature and pediatric patients requiring non-cervical spinal fixation for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed previous fusion. Pediatric use limited to posterior approach for progressive deformities and specific pathologies.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker Spine XIA® 4.5 Spinal System (K152632)

Reference Devices

• Stryker Spine DIAPASON® Spinal System
• Opus® Spinal System
• XIA® Stainless Steel
• XIA® II
• XIA® Anterior
• XIA® Precision
• XIA® 3 Spinal System
• Radius® Spinal System
• MANTIS® Spinal System
• MANTIS® Redux Spinal System
• ES2® Spinal System

Submission Summary (Full Text)

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October 10, 2017

Stryker Corporation Ms. Priyanka Patel Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K172724

Trade/Device Name: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 8, 2017 Received: September 11, 2017

Dear Ms. Patel:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

#### K172724

Device Name XIA® 4.5 Spinal System

Indications for Use (Describe)

The XIA® 4.5 Spinal System is intended for 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.

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)

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### Indications for Use

510(k) Number (if known) K172724

### Device Name

Power Adaptor Instrument Accessory

#### Indications for Use (Describe)

#### Intended Use (Power):

To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implanted in the non-cervical spine usine using powered (corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless Steel, XIA® II. XIA® Anterior, and XIA® Precision), XIA® 4.5 Spinal System, Radius® Spinal System. MANTIS® Spinal System. MANTIS® Redux Spinal System, and the ES2® Spinal System.

#### Indications for Use (Power):

The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is intended for anterolateral 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, 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.

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, 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 tunor and/or

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trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

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, 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.

The MANTIS® Spinal System, 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 dise 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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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| XIA 4.5 Spinal System | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Stryker Corporation<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
| Contact Person | Priyanka Patel<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | September 8, 2017 |
| Trade Name | XIA® 4.5 Spinal System,<br>Power Adaptor Instrument Accessory |
| Proposed Class | Class II |
| Classification Name<br>and Number | • Thoracolumbosacral Pedicle Screw System, 21 CFR §<br>§ 888.3070<br>• Spinal Intervertebral Body Fixation Orthosis, 21 CFR §<br>888.3060<br>• Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 |
| Product Code | NKB, KWP, KWQ |
| Predicate Devices | The XIA 4.5 Spinal Fixation System was shown to be<br>substantially equivalent to the device listed below:<br>Primary Predicate<br>• Stryker Spine XIA® 4.5 Spinal System (K152632) |
| Device Description | The XIA® 4.5 Spinal System is comprised of Monoaxial,<br>Polyaxial and reduction bone screws, Cortical Trajectory<br>(CT) bone screws (cannulated and non-cannulated), hooks,<br>dual staples, and blockers that affix rods, rod-to-rod<br>connectors, growth connectors, and cross connectors to<br>vertebrae of the spinal column.<br><br>The subject submission will introduce line extension of non-<br>cannulated dual lead self-tapping Xia® Cortical trajectory<br>(CT) bone screws, sub components of existing XIA® 4.5<br>Spinal System. Ø5.5, Ø 6.5, and Ø7.5 with a length of 35mm-<br>70mm screws are to be added. The new components will be<br>used in the same manner as the predicate XIA® 4.5 Spinal<br>System.<br><br>The Xia® 4.5 Spinal System, including the new Xia® Cortical<br>Trajectory implants, will continue to be used with the<br>Stryker Spine Power Adaptor Accessory Instrument. The<br>Stryker Instruments Hudson Modified Trinkle Reamer, the<br>CD3 Cordless Driver 3 System, and the RemB Universal |
| XIA 4.5 Spinal System | |
| | Driver, are used with Stryker Spine Power Adaptor to<br>facilitate the insertion of the pedicle screws. The adaptors<br>serve as a mechanical interface between the power drivers<br>and screwdriver instruments. When the adaptor is attached<br>to the Hudson Modified Trinkle Reamer, the RemB Corded<br>driver or the CD3 Cordless Driver 3 provides appropriate<br>power to rotate the screw drivers for the insertion of the<br>pedicle screws |
| Intended Use and<br>Indications for Use | The XIA® 4.5 Spinal System is intended for<br>anterior/anteriolateral and posterior, non-cervical pedicle<br>and non-pedicle fixation for the following indications: |
| | Degenerative Disc Disease (as defined by back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>patient history and radiographic studies)<br>● Spondylolisthesis<br>● Trauma (i.e. fracture of dislocation)<br>● Spinal Stenosis<br>● Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)<br>● Tumor<br>● Pseudarthrosis<br>● Failed Previous Fusion |
| | The Stryker Spine DIAPASON® Spinal System, Opus® Spinal<br>System, and XIA® 4.5 Spinal System can be linked to the XIA®<br>4.5 Spinal System via the rod-to-rod connector when used<br>for the aforementioned indications in skeletally mature<br>patients as an adjunct to fusion. |
| | Except for the staples, when used for posterior non-cervical<br>pedicle screw fixation in pediatric patients, the XIA® 4.5<br>Spinal System implants are indicated as an adjunct to fusion<br>to treat progressive spinal deformities (i.e. scoliosis,<br>kyphosis, or lordosis) including idiopathic scoliosis,<br>neuromuscular scoliosis, and congenital scoliosis.<br>Additionally, the XIA® 4.5 Spinal System is intended to treat<br>pediatric patients diagnosed with:<br>spondylolisthesis/spondylolysis, fracture caused by tumor<br>and/or trauma, pseudarthrosis, and/or failed previous<br>fusion. This system is intended to be used with autograft |
| | and/or allograft. Pediatric pedicle screw fixation is limited<br>to a posterior approach. |
| XIA 4.5 Spinal System | |
| Indications &<br>Intended Use with<br>Powered<br>Instruments | <b>Intended Use (Power):</b><br>To facilitate the placement of pedicle screws using the power<br>technique (corded and cordless), the use of the Stryker Spine<br>Power Adaptor is intended for exclusive use with the Stryker<br>Instruments Hudson Modified Trinkle Reamer and the<br>Stryker Instruments CD3 Cordless Driver 3 and the Stryker<br>Instruments RemB Universal Driver. When the power<br>adaptors are attached, the CD3 Cordless Driver 3 and RemB<br>Universal Driver provide power (corded and cordless) to<br>rotate screwdrivers for the insertion of pedicle screws.<br><br>Pedicle screws from select Stryker Spine implant systems<br>may be implanted in the non-cervical spine using powered<br>(corded and cordless) instrumentation. The systems<br>included are the family of XIA® Spinal Systems (XIA®<br>Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision),<br>XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal<br>System, MANTIS® Spinal System, MANTIS® Redux Spinal<br>System, and the ES2® Spinal System.<br><br><b>Indications for Use (Power):</b><br>The XIA® Spinal System is intended for<br>anterior/anteriolateral and posterior, non-cervical pedicle<br>and non-pedicle fixation in skeletally mature patients as an<br>adjunct to fusion for the following indications: Degenerative<br>Disc disease (DDD) (defined as back pain of discogenic origin<br>with degeneration of the disc confirmed by history and<br>radiographic studies); spondylolisthesis; trauma (i.e. fracture<br>or dislocation); spinal stenosis; curvature (i.e. scoliosis,<br>kyphosis, and/or lordosis); tumor; pseudoarthrosis; and<br>failed previous fusion.<br><br>The XIA® 3, RADIUS® Spinal Systems are intended for use in<br>the non-cervical spine. When used as an<br>anterior/anteriolateral and posterior, non-cervical pedicle<br>and non-pedicle fixation system, the XIA® II, XIA® 3, and<br>RADIUS® Spinal Systems are intended to provide additional<br>support during fusion using autograft or allograft in<br>skeletally mature patients in the treatment of the following<br>acute and chronic instabilities or deformities: degenerative<br>disc disease (DDD) (defined as back pain of discogenic origin<br>with degeneration of the disc confirmed by history and<br>radiographic studies); spondylolisthesis; trauma (i.e. fracture<br>or dislocation); spinal stenosis; curvature (i.e. scoliosis, |
| Section 8 - 510(k) Summary | |
| XIA 4.5 Spinal System |…