XIA SPINAL SYSTEM

K053115 · Stryker Spine · MNI · Dec 6, 2005 · Orthopedic

Device Facts

• Record ID: K053115
• Device Name: XIA SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: MNI · Orthopedic
• Decision Date: Dec 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine: and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system, the Xia Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. The 6mm 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 Tita Connectors are intended to be used with the other components of the Xia Titanium Spinal System.

Device Story

Xia Spinal System is a spinal fixation system comprising monoaxial/polyaxial screws, washers, hooks, blockers, rods, staples, and connectors. This line extension adds 4.0 mm diameter screws in titanium alloy and stainless steel. Used by surgeons in the OR to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Components are implanted to stabilize the spine; intended for removal after solid fusion mass development. System integrates with 6mm rods from DIAPASON and OPUS systems and titanium multi-axial cross connectors. Benefits include structural support for spinal instabilities and deformities.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing demonstrating comparable mechanical properties to predicate devices.

Technological Characteristics

Components manufactured from titanium alloy, CP titanium, or stainless steel. System includes monoaxial/polyaxial screws, hooks, rods, and connectors. 4.0 mm diameter screw line extension. Mechanical fixation principle. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal stabilization/immobilization. Conditions include severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, and failed previous fusion. Also indicated for degenerative disc disease (discogenic back pain).

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® Stainless Steel System (K012870 & K031090)
• Stryker Spine Xia® Spinal System (K013823)
• DePuy Inc., Moss Miami Spinal System (K962628)

Reference Devices

• DIAPASON™ Spinal System
• OPUS™ Spinal System

Submission Summary (Full Text)

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DEC 6 2005

# Special 510(k) Premarket Notification

KDS3115

#### Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia® Spinal System

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
|--------------------------------------------------------------|-----------------------------------------------------------------------|
| Contact Person: | Simona Voic<br>Regulatory Affairs Project Manager<br>(201) 760 - 8145 |
| Date of Summary Preparation: | October 31, 2005 |
| <b>Device Identification</b> | |
| Proprietary Name: | Xia® Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis, |
| | 21 CFR §888.3050 |
| | Spinal Intervertebral Body Fixation Orthosis |
| | 21 CFR §888.3060 |
| | Pedicle Screw Spinal System |
| | 21 CFR §888.3070 |
| <b>Predicate Device Information:</b> | |
| | Stryker Spine Xia® Stainless Steel System<br>(K012870 & K031090) |
| | Stryker Spine Xia® Spinal System (K013823) |
| | DePuy Inc., Moss Miami Spinal System (K962628) |

### Predicate Device Identification

The Stryker Spine Xia " Spinal Fixation System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, and Connectors. The components are manufactured from either Titanium material (Ti alloy and CP Titanium) or Stainless Steel.

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#### Description of Device Modification

This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Titanium alloy and Stainless Steel 4.0 mm diameter spinal screws.

#### Intended Use:

The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia® Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia® Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6mm 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 System.

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### Statement of Technological Comparison:

The subject components share the same intended use, material, and basic design concepts as that of the predicate device: Stryker Spine Xia® Spinal System (K013823, K012870, and K031090). Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Stryker Spine Xia® Spinal System (K013823) and DePuy Inc. Moss Miami Spinal System (K962628).

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the department's logo, which is a stylized caduceus with three lines representing the three branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular pattern. The text is written in all capital letters.

Public Health Service

2005 DEC 6

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K053115

Trade/Device Name: Xia® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWQ, KWP Dated: November 4, 2005 Received: November 7, 2005

Dear Ms. Voic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 complics 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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#### Page 2 - Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

1 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS3115

## Indications for Use

510(k) Number (if known): K كا // 510(k) كا

Device Name: Xia® Spinal System

Indications For Use:

ど

The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine: and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6mm 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 Tita Connectors are intended to be used with the other components of the Xia Titanium Spinal System.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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and Neurological Devices

510(k) Number_