BUTTERFLY PLATE FIXATION SYSTEM

K014267 · Medtronic Sofamor Danek, Inc. · KWP · Jan 25, 2002 · Orthopedic

Device Facts

• Record ID: K014267
• Device Name: BUTTERFLY PLATE FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. 7. Unsuccessful previous fusion surgery. 8. Lordotic deformities of the spine. 9. Idiopathic thoracolumbar or lumbar scoliosis. 10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. 11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

Device Story

BUTTERFLY PLATE Fixation System provides temporary stabilization of thoracic and lumbar spine (T1-L5) via anterolateral intervertebral body fixation. System comprises titanium alloy plates, screws, bolts, and nuts; construct is tailor-made for individual patient anatomy. Surgeon attaches plate to vertebral bodies using rigid bolts or variable-angle screws on one side of spine. Device maintains alignment until solid spinal fusion occurs. Used in clinical settings by surgeons; output is mechanical stabilization of spinal segments. Benefits include correction of deformities and stabilization of degenerative or traumatic spinal conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence based on risk analysis and bench testing.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. Components: Plates, screws, bolts, nuts. Configuration: Anterolateral intervertebral body fixation. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring temporary spinal stabilization during fusion from T1 to L5. Conditions include DDD, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed prior fusion, lordotic deformities, idiopathic thoracolumbar/lumbar scoliosis, deformities with deficient posterior elements (laminectomy, spina bifida, myelomeningocele), and neuromuscular deformity with pelvic obliquity. Contraindicated for posterior element (pedicle) attachment.

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

• BUTTERFLY PLATE Fixation System (K010632)
• Sofamor Danek Z-Plate Anterior Fixation System (K922543)

Submission Summary (Full Text)

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## Medtronic Sofamor Danek BUTTERFLY PLATE Fixation System 510(k) Summary December 2001

K014267
Page 1 of 2

| Submitter: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132 | JAN 2 5 2002 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Richard Treharne | |
| Trade Name: | BUTTERFLY PLATE Fixation System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II | |
| Predicate Device(s): | The BUTTERFLY PLATE Fixation System is substantially equivalent to itself, the BUTTERFLY PLATE Fixation System, which was cleared in K010632 on May 31, 2001 and the Sofamor Danek Z-Plate Anterior Fixation System, which was cleared on May 19, 1993. | |
| Device Description: | The BUTTERFLY PLATE Fixation System construct consists of a plate fitted to match the antero-lateral vertebral bodies of the thoracic and lumbar spine. The plate is fastened to the bodies by either rigid bolts or variable-angle screws. The BUTTERFLY PLATE consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. The BUTTERFLY PLATE anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to add a cover plate to the system and to add a 6.5mm screw. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832- 3. Stainless steel and titanium implant components must not be used together in a construct. | |
| Intended Use: | The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. | |
| | When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: | |
| 1. | Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). | |
| 2. | Pseudoarthrosis. | |
| 3. | Spondylolysis. | |
| 4. | Spondylolisthesis. | |
| 5. | Fracture. | |
| 6. | Neoplastic disease. | |
| 7. | Unsuccessful previous fusion surgery. | |
| 8. | Lordotic deformities of the spine. | |
| 9. | Idiopathic thoracolumbar or lumbar scoliosis. | |

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- 10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated 11. with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

Functionality & Safety Testing: A Risk Analysis was performed on the BUTTERFLY PLATE and was included in this submission. Conclusion: The subject components contained in this submission are substantially equivalent to the original BUTTERFLY PLATE Fixation System (K010632) and to the Sofamor Danek Z-Plate Anterior Fixation System (K922543).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 emblem resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K014267

Trade Name: Butterfly Plate Fixation System Regulation Number: 888.3050 and 888.3070 Regulatory Name: Spinal interlaminal fixation orthosis and Pedicle Screw System Regulatory Class: II Product Code: KWP and MNH Dated: December 21, 2001 Received: December 27, 2001

Dear Dr. Treharne:

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.

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.

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Page 2 - Richard W. Treharne, Ph.D.

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 additionally 607.10 for in This and includes on the promotion and advertising of your device, [phone]. Radinonary, con use at [phone]. Also, please note the regulation prease condor the Orifice or Somphanes et notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and its tollars. Inc. 100 million in [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, Pam,

Mark McMullen

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): ____________________________________________________________________________________________________________________________________________________

## Device Name: BUTTERFLY PLATE FIXATION SYSTEM

The BUTTERFLY™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

- 2. Pseudoarthrosis.
- 3. Spondylolysis.
- 4. Spondylolisthesis.
- 5. Fracture.
- 6. Neoplastic disease.
- 7. Unsuccessful previous fusion surgery.
- 8. Lordotic deformities of the spine.
- 9. Idiopathic thoracolumbar or lumbar scoliosis.

10. Deformity (i.e., scoliosis, lordosis) and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.

11. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity. Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.

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## Concurrence of CDRH Office of Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

OR

R

Over-the-counter Use

Mark N. Milken

Restorat

510(k) Number