MODIFICATION TO XIA STAINLESS STEEL SYSTEM

K031090 · Howmedica Osteonics Corp. · KWP · Apr 24, 2003 · Orthopedic

Device Facts

• Record ID: K031090
• Device Name: MODIFICATION TO XIA STAINLESS STEEL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWP · Orthopedic
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel 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 as 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Device Story

Xia Stainless Steel System is a spinal fixation implant set; includes polyaxial screws, monoaxial screws, rods, hooks, blockers, and connectors. Line extension adds 4.5 mm diameter polyaxial screws and longer rods. Used by surgeons in OR for noncervical spinal stabilization/immobilization. Implants provide mechanical support to spinal segments during fusion process; removed after solid fusion mass development. Benefits include stabilization of unstable spinal segments and correction of deformities.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stainless steel spinal fixation system; components include polyaxial/monoaxial screws, rods, hooks, and connectors. Mechanical fixation principle. Non-active, non-implantable software. Sterilization method not specified.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for noncervical spine conditions including severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, failed fusion (pseudarthrosis), spinal stenosis, kyphosis, and lordosis.

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 Stainless Steel System (K031090)

Submission Summary (Full Text)

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# APR 2 4 2003

Special 510(k) Premarket Notification

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

### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | April 4, 2003 |
| Device Identification | |
| Proprietary Name: | Xia Stainless Steel 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 Identification

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

#### Description of Device Modification

This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes 4.5 mm diameter Polyaxial Screws and longer length rods.

#### Intended Use:

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel 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 as 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

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Image /page/1/Picture/1 description: The image shows the text "KO31090 P2/2" in a handwritten-like font. Below this, the text "Special 510(k) Premarket Notification" is printed in a formal font. The text at the top appears to be a reference or code, while the text at the bottom indicates the document's purpose.

confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, 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 device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K031090

Trade/Device Name: XIA Stainless Steel System Regulatory Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: April 4, 2003 Received: April 7, 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. Iisting 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

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Page 2 - Ms. Karen Ariemma

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. 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,

Miriam C. Provost

tos 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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510(k) Number (if known): K031090

#### Device Name: Xia Stainless Steel System

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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts,

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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)

Muriam C. Provost

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

510(k) Number K031090