MODIFICATION TO XIA SPINAL SYSTEM

K052181 · Stryker Spine · KWP · Sep 8, 2005 · Orthopedic

Device Facts

• Record ID: K052181
• Device Name: MODIFICATION TO XIA SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: KWP · Orthopedic
• Decision Date: Sep 8, 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, 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 Titanium Multi-Axial Cross 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 consisting of titanium alloy components including screws, rods, hooks, and connectors. This line extension adds a range of offset and rod-to-rod connectors. The system is used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments during fusion procedures. Components are implanted to treat various spinal instabilities and deformities. The device provides mechanical support to the spine, facilitating fusion and potentially reducing patient pain and deformity. The system is intended for use in the noncervical spine.

Clinical Evidence

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

Technological Characteristics

Titanium alloy components including offset and rod-to-rod connectors. System includes monoaxial/polyaxial screws, washers, hooks, blockers, rods, staples, and multi-axial cross connectors. Mechanical fixation principle. Non-powered, mechanical implant system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization in the noncervical spine (thoracic, lumbar, sacral). Conditions include severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion. Used as adjunct to fusion with autogenous bone graft.

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

• K013823 Stryker Spine Xia Spinal System
• K013688 OSS and Opus Rods – Use with Xia Spinal System
• K002505 Line Extension - Xia Spine System
• K043473 Line Extension – Xia Spinal System

Reference Devices

• DIAPASON™ Spinal System
• OPUS™ Spinal System

Submission Summary (Full Text)

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SEP - 8 2005

Image /page/0/Picture/2 description: The image shows the text "Special 510(k) Premarket Notification" along with the number K052181 at the top. The text is in a simple, sans-serif font, and the number is handwritten. The image appears to be a scan or photograph of a document.

## 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: | August 8, 2005 |
| Device Identification | |
| Proprietary Name: | Xia® Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,<br>21 CFR §888.3050<br>Spinal Intervertebral Body Fixation Orthosis<br>21 CFR §888.3060<br>Pedicle Screw Spinal System<br>21 CFR §888.3070 |
| Predicate Device Information: | |
| | K013823 Stryker Spine Xia Spinal System |
| | K013688 OSS and Opus Rods – Use with Xia<br>Spinal System |
| | K002505 Line Extension - Xia Spine System |
| | K043473 Line Extension – Xia Spinal System |

### Predicate Device Identification

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

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K052181 P2
Special 510(k) Premarket Notification

### Description of Device Modification

This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.

#### 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: Xia Spinal System (K013823). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES". The symbol in the center appears to be a stylized depiction of an eagle or bird with outstretched wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2005

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

Re: K052181 Trade/Device Name: Xia Spinal System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: August 8, 2005 Received: August 10, 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 for asservior 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 Cosmatic 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 Codc 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 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-Ms.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/industry/support/index.html.

Sincerely yours,
Mark A. Millizen

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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# Indications for Use

510(k) Number (if known): K 052181

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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacralfiliac 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 Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

x 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

Mark Millan

(Division Sign-Off) al. Restorative, and Neurologica

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