MODIFICATION TO XIA SPINAL SYSTEM

K043473 · Stryker Spine · KWP · Jan 12, 2005 · Orthopedic

Device Facts

• Record ID: K043473
• Device Name: MODIFICATION TO XIA SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: KWP · Orthopedic
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• 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 stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts. The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of Xia " Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia® Titanium Spinal System.

Device Story

Xia Spinal System is a spinal fixation assembly consisting of monoaxial/polyaxial screws, washers, hooks, blockers, rods, connectors, and cross-connectors. Modification adds cannulated polyaxial screws to existing system. Used by surgeons in OR to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as adjunct to fusion. Components are implanted to stabilize segments during bone healing; device may be removed after solid fusion. System utilizes titanium alloy and CP titanium. Output is mechanical stabilization of spine.

Clinical Evidence

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

Technological Characteristics

Components manufactured from titanium alloy and CP titanium. System includes monoaxial/polyaxial screws, hooks, rods, and connectors. Cannulated polyaxial screws added. Mechanical fixation principle. Non-powered, mechanical implant system.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal stabilization/fixation. Conditions include severe spondylolisthesis (L5-S1), degenerative disc disease, fracture, dislocation, scoliosis, kyphosis, spinal stenosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Xia Spine System (K002858)
• Xia Spinal System (K013823)

Reference Devices

• DIAPASON™ Spinal System
• OPUS™ Spinal System

Submission Summary (Full Text)

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

| Proprietary Name: | Xia® Spinal System |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II<br>Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050<br>Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060<br>Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Device Product Code: | 87 KWP: Appliance, Fixation, Spinal Interlaminal<br>87 KWQ: Appliance, Fixation, Spinal, Intervertebral Body<br>87 MNH: Spondylolisthesis Spinal Fixation System<br>87 MNI: Orthosis, Spinal, Pedicle Fixation |
| For Information contact: | Simona Voic<br>Regulatory Affairs Project Manager<br>2 Pearl Court<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | January 5, 2005 |
| Predicate Device Identification: | K002858 Xia Spine System<br>K013823 Xia Spinal System |

# Predicate Device Description

The Xia Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple. The components are manufactured from Titanium material (Ti alloy and CP Titanium).

# Description of Device Modification

The purpose of this submission is to include cannulated polyaxial screws to the Xia Titanium Spinal System.

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# 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 stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of Xia " Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia® Titanium Spinal System.

# Statement of Technological Comparison:

The subject components share the same intended use and basic design concepts as that of the predicate device. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

JAN 1 2 2005

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: K043473

Trade/Device Name: Xia® Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, and 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, and Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWO, MNH, and MNI Dated: December 14, 2004 Received: December 16, 2004

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 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); good manufacturing practice requirements as se 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 - Ms. 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 (240) 276-__ 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,

Mark A. Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K043473

Device Name: Xia Spinal System

Indications For 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 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of Xia Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia Titanium Spinal System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD (Part 21 CFR 801 Subpart D)

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)

(Division Sign-On)
Division of General, Restorative,
and Neurological Devices

510(k) Number K043473

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