XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM

K031893 · Howmedica Osteonics Corp. · KWP · Jul 17, 2003 · Orthopedic

Device Facts

• Record ID: K031893
• Device Name: XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar 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 and Xia Stainless Steel Systems are 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 and Xia Stainless Steel Systems are 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.

Device Story

Xia Spinal System and Xia Stainless Steel System are spinal fixation implants; line extension adds dual staple and modified cross connectors for anterior fixation. Components include monoaxial/polyaxial screws, washers, hooks, blockers, rods, connectors, and staples. Used in thoracic, lumbar, and sacral spine to provide immobilization and stabilization as an adjunct to fusion. Operated by surgeons in clinical/OR settings. Mechanical fixation provides structural support to spinal segments; aids in fusion development. Benefits include stabilization of acute/chronic instabilities or deformities.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Spinal fixation system components including dual staples and cross connectors. Materials include stainless steel. Mechanical fixation principle. Non-active, implantable device.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal stabilization/immobilization as an adjunct to fusion. Conditions include severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, and degenerative disc disease (back pain of discogenic origin).

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Line Extension to the Nia Spinal System and the Xia Stainless Steel System

Special 510(k) Premarket Notification

# 'JUL 1 7 2003

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

| Proprietary Name: | Xia Spinal System and Xia Stainless Steel 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 |
| | 87 KWQ: Appliance, Fixation, Spinal, Intervertebral Body |
| | 87 MNH: Spondylolisthesis Spinal Fixation System |
| | 87 MNI: Orthosis, Spinal, Pedicle Fixation |
| For Information contact: | Karen Ariemma |
| | Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 59 Route 17 |
| | Allendale, NJ 07401-1677 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Summary Prepared: | May 30, 2003 |

## Predicate Device Identification

The Xia Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple.

The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple.

## Description of Device Modification

This submission is intended to address a line extension to both the Xia Spinal System and the Xia Stainless Steel System. The line extension includes a Dual Staple and modified cross connectors. The new components will be used for anterior fixation.

{1}------------------------------------------------

Special 510(k) Premarket Notification

#### Intended Use:

031893
page 2 of 2

The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar 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 and Xia Stainless Steel Systems are 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 and Xia Stainless Steel Systems are 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.

#### 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 17 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K031893

Trade/Device Name: Xia Spinal System and Xia Stainless Steel System Regulation Number: 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ,MNI, MNH Dated: June 17, 2003 Received: June 19, 2003

Dear Ms. Ariemma:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Karen Ariemma

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.

Sincerely, yours,

Mark N. Mulkerson

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

{4}------------------------------------------------

# 510(k) Number (if known): K 03 189 7

Device Name: Xia Spinal System and Xia Stainless Steel System

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 (LS-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 turnor, and failed previous fusion (pseudarthrosis).

When used 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, turnor, pseudoarthrosis or revision of failed fusion attempts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark N. Milburn
for Division of Oil

Division Sion-Division of General, Restorative and Neurological Devices

510(k) Number K031813

{5}------------------------------------------------

# 510(k) Number (if known): K 0 31893

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine 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 Stainless Steel 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 an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Mark N. Milliken

Division of General, Restorative and Neurological Devices

510(k) Number K031893

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)