XIA SPINE SYSTEM

K984251 · Howmedica, Inc. · KWQ · Feb 24, 1999 · Orthopedic

Device Facts

• Record ID: K984251
• Device Name: XIA SPINE SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XIA Spine 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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium. When used as a pedicle screw fixation system, the XIA Spine 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 an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

Device Story

The XIA Spine System is a spinal fixation construct consisting of titanium rods, monoaxial and polyaxial bone screws, hooks, closure screws, rod-to-rod clamps, lateral connectors, and cross-link components. It is used by surgeons in the operating room to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine. The system is implanted to facilitate fusion in patients with acute or chronic spinal instabilities or deformities. By providing rigid fixation, the device maintains spinal alignment and stability, allowing for the development of a solid fusion mass, which can alleviate pain and correct deformities. The device is intended for removal after fusion is achieved in specific pedicle screw applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from titanium. Components include rods, monoaxial/polyaxial bone screws, hooks, closure screws, rod-to-rod clamps, lateral connectors, and cross-links. Designed for noncervical spinal fixation (thoracic, lumbar, sacral).

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal fixation for conditions including severe spondylolisthesis (L5-S1), degenerative disc disease, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis, or revision of failed fusion. Used as adjunct to fusion with autogenous bone graft.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• BWM Spine System
• Universal Spinal System (USS) (Synthes Spine)
• MOSS Miami Spinal System (DePuy)

Submission Summary (Full Text)

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

K98425)

## 510(k) Summary

## XIA SPINE SYSTEM

Common Name: Classification Name:

(888.3060)

Device:

Requlatory Class: Product Code:

Spinal Fixation Device Spinal Interlaminal Fixation Orthosis (888.3050) Spinal Intervertebral Body Fixation Orthosis

Pedicle Screw Spinal System (888.7070) Class II 87KWP, 87KWQ, 87MNH and 87MNI

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 [phone] Fax: [phone]

The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.

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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as a pedicle screw fixation system, the XIA Spine 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).

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

When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoricic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to other predicate devices indicated for noncervical spinal fixation. These devices include Howmedica's BWM Spine System, Synthes® Spine's Universal Spinal System (USS) and the MOSS Miami Spinal System by DePuy. Bench testing demonstrates that the device will meet it mechanical functional requirements.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

K984251

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re:

Trade Name: XIA Spine System Regulatory Class: II Product Codes: KWP, KWQ, MNH, and MNI Dated: November 25, 1998 Received: November 27, 1998

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. John F. Dichiara

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K98425 |

Device Name:

XIA SPINE SYSTEM

The XIA Spine 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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as a pedicle screw fixation system, the XIA Spine 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 an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|----------|----|-----------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> | OR | Over-The-Counter Use ______ |
| (Optional Format 1-2-96) | | | |
| (Division Sign-Off) | | | |
| Division of General Restorative Devices | | | |
| 510(k) Number | K984251 | | |