BWM SPINE SYSTEM

K982494 · Howmedica Corp. · KWP · Sep 8, 1998 · Orthopedic

Device Facts

• Record ID: K982494
• Device Name: BWM SPINE SYSTEM
• Applicant: Howmedica Corp.
• Product Code: KWP · Orthopedic
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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. Pedicle screw fixation is limited to L3 to S1 or the ilium. When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the 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.

Device Story

BWM Spine System is a spinal fixation construct comprising titanium rods, screws (pedicle, sacral/iliac, articular, closure), hooks, nuts, and cross-bridge components. Used by surgeons in clinical settings to stabilize the noncervical spine. Operates via mechanical fixation to provide structural support during spinal fusion procedures. Surgeon selects and assembles components intraoperatively to achieve desired spinal alignment and stability. Output is a rigid construct that immobilizes vertebral segments to facilitate bone fusion. Benefits include stabilization of the spine in patients with severe deformities, fractures, or degenerative conditions. Device is intended for removal following successful fusion.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium components including rods, pedicle/sacral/iliac/articular/closure screws, hooks, nuts, and cross-bridge components. Mechanical fixation system for noncervical spine. No software or energy source.

Indications for Use

Indicated for noncervical spine fixation. Pedicle screw use limited to patients with severe spondylolisthesis (Grades 3-4) at L5-S1, requiring autogenous bone graft, with removal after fusion; limited to L3-S1/ilium. Other system configurations indicated for degenerative disc disease (discogenic back pain), spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion.

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

• Synthes Spine's Universal Spinal System (USS)
• Isola Spinal System by Acromed
• DePuy Motech MOSS Miami Spinal System

Submission Summary (Full Text)

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SEP 8 1998

Device:

Proprietary Name: Common Name: Classification Name:

Regulatory Class: Product Code:

For information contact:

510(k) Summary

BWM SPINE SYSTEM

BWM Spine System Spinal Fixation Device Spinal Interlaminal Fixation Orthosis (888.3050) Spinal Intervertebral Body Fixation Orthosis (888.3060) Spondvlolisthesis Spinal Fixation Device (888.7070) (proposed to Class II in 60 FR 51946) Class II 87KWP, 87KWQ and 87MNH

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

The system consists of rods, screws, pedicle screws, sacral/iliac screws, hooks, articular screws, closure screws, nuts, and cross bridge components. The components are manufactured from titanium.

The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the 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 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 Synthes® Spine's Universal Spinal System (USS), Isola® Spinal System by Acromed® and the DePuy Motech MOSS Miami Spinal System. Bench testing demonstrates that the device will meet its mechanical functional requirements.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with three heads. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1998

Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica. Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K982494 BWM Spine System Regulatory Class: II Product Codes: MNH, KWP and KWQ Dated: July 16, 1998 Received: July 17, 1998

Dear Ms. Kelly:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(t) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- 1. All labeling for this device, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe

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spondylolisthesis (Grades 3 and 4) of 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.

- 2. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
## WARNINGS:

- When used as a pedicle screw system, this device system is intended only for . grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- . Potential risks identified with the use of this device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra. neurological injury, and vascular or visceral injury.

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

- 3. Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- 4. Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

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Page 3 - Ms. Vivian Kelly

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.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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,

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

Enclosure

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Indications for Use

510(k) Number (if known): K982494

Device Name:

BWM SPINE SYSTEM

Indications for Use:

The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

signature

on Sion-Off Division of General Restorative Devices

510(k) Number_k982494

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