MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

K991460 · Sofamor Danek · MNH · May 19, 1999 · Orthopedic

Device Facts

• Record ID: K991460
• Device Name: MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
• Applicant: Sofamor Danek
• Product Code: MNH · Orthopedic
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• 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 TI 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. 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. 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™ is an anterior spinal fixation system comprising plates, bolts, screws, washers, and nuts. Used by surgeons in clinical settings to provide temporary stabilization of the anterolateral intervertebral bodies (T1-L5) until solid spinal fusion occurs. Components are configured and locked by the surgeon to create a construct tailored to the patient's anatomy. The system is placed unilaterally, positioned to avoid major blood vessels (aorta) and nerve roots. By stabilizing the spinal segment, the device supports the fusion process, potentially reducing pain and correcting spinal deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of metallic plates, bolts, screws, washers, and nuts. Mechanical fixation device; no energy source or software. Designed for anterolateral spinal attachment.

Indications for Use

Indicated for patients requiring temporary stabilization of the spine (T1-L5) to facilitate fusion. 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 deformity with pelvic obliquity. Contraindicated for posterior element (pedicle) attachment.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Submission Summary (Full Text)

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Z-PLATE ATL™ Anterior Spinal Fixation System 510(k) Summary April 26, 1999

Sofamor Danek USA I. Company: 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, washers 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.

#### Indications IV.

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).
- 2. Pseudoarthrosis.
- 3. Spondylolysis.
- Spondylolisthesis. 4.
- న. Fracture.
- Neoplastic disease. 6.
- Unsuccessful previous fusion surgery. 7.
- Lordotic deformities of the spine. 8.
- 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, fordosis, 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.

K99,460

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1999

Richard W. Treharne, Ph.D. Richard w. Trendino, and Regulatory Affairs Sofamor Danek 1800 Pyramid Place 38132 Memphis, Tennessee

K991364 Re: TENOR™ Spinal System Trade Name: K991460 ZPlate-ATL™ Anterior Fixation System Trade Name: Requlatory Class: II Product Codes: MNH and KWP April 19 and 26, 1999 Dated: April 20 and 27, 1999 Received:

Dear Dr. Treharne:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 aqainst misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

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

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 requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (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 devices, 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celra M. Witten, Ph.D., M

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

Enclosures

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510(k) Number (if known):

Device Name: _ZPLATE-ATL™ 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 TI 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).
- Pseudoarthrosis. 2.
- Spondylolysis. 3.
- Spondylolisthesis. 4.
- રું. Fracture.
- 6. Neoplastic disease.
- Unsuccessful previous fusion surgery. 7.
- 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.

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

## Concurrence of CDRH, Office of Evaluation (ODE)

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

OR

Over-the-counter Use

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