MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

K982875 · Danek Medical, Inc. · KWQ · Jan 19, 1999 · Orthopedic

Device Facts

• Record ID: K982875
• Device Name: MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
• Applicant: Danek Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 19, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZPLATE-ATL™ Anterior 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: - Degenerative disc disease (as defined 1. by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). - Pseudoarthrosis. 2. - Spondylolysis. র . - র্ব . Spondylolisthesis. - ২. Fracture. - 6. Neoplastic disease. - Unsuccessful previous fusion surgery. 7. - Lordotic deformities of the spine. 8. - 9. Idiopathic thoracolumbar or lumbar scollosis - 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. Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

Device Story

ZPLATE-ATL™ Anterior Spinal Fixation System II provides temporary stabilization of the spine to facilitate fusion. System comprises various plates, bolts, screws, and nuts. Surgeon implants device via anterolateral approach to intervertebral bodies (T1-L5). Device is used unilaterally, positioned to avoid aorta and nerve roots. Provides mechanical support until solid spinal fusion occurs. Used in clinical settings by surgeons for spinal deformity and degenerative conditions.

Clinical Evidence

No clinical data provided.

Technological Characteristics

System consists of plates, bolts, screws, and nuts of various shapes and sizes. Designed for anterolateral intervertebral body fixation. Mechanical stabilization device; no energy source or software components.

Indications for Use

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

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.

Submission Summary (Full Text)

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JAN 1 9 1999

- 1. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 [phone]
### Proprietary Trade Name: ZPLATE-ATL™ Anterior Spinal Fixation System II.

### III. Product Description

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

### IV. Indications

The ZPLATE-ATL™ Anterior 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 (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- 2. Pseudoarthrosis.
- Spondylolysis. 3.
- Spondylolisthesis. 4.
- રું. Fracture.
- Neoplastic disease. ર.
- 7. Unsuccessful previous fusion surgery.
- Lordotic deformities of the spine. 8.
- Idiopathic thoracolumbar or lumbar 9. 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.

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

- V. Substantial Equivalence
Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

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

Re: K982875

> ZPLATE-ATLTM Anterior Fixation System - Locking Screw Regulatory Class: II Product Code: KWQ Dated: December 28, 1998 Received: December 29, 1998

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

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

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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/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

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# 510(k) Number (if known): K982875

Device Name: ZPLATE-ATLTM Anterior Fixation System

## Indications for Use:

The ZPLATE-ATL™ Anterior 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:

- Degenerative disc disease (as defined 1. by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis. 2.
- Spondylolysis. র .
- র্ব . Spondylolisthesis.
- ২. Fracture.
- 6. Neoplastic disease.
- Unsuccessful previous fusion surgery. 7.
- Lordotic deformities of the spine. 8.
- 9. Idiopathic thoracolumbar or lumbar scollosis
- 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.

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

Over-the-counter Use

PAOLO