TITANIUM VERSALOK

K990708 · Wrightmedicaltechnologyinc · KWP · Mar 30, 1999 · Orthopedic

Device Facts

• Record ID: K990708
• Device Name: TITANIUM VERSALOK
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWP · Orthopedic
• Decision Date: Mar 30, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass. When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to: 1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors; 2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); 3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: Progressive, despite other forms of treatment, Detrimental to cardiopulmonary function, Interfering with spinal mechanics or causing severe back pain, or Cosmetically unacceptable, progressive, and painful. The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.

Device Story

Titanium Versalok Screw Assembly is a spinal fixation system consisting of straight rods, outer rings, caps, and polyaxial screws. Implanted via posterior surgical approach by surgeons to provide temporary spinal stability during bony fusion healing. Device supports spine in cases of fractures, tumors, degenerative disk disease, or spinal curvatures. Once solid fusion occurs, device is intended for removal. Provides mechanical maintenance and support of spinal correction during fusion mass maturation.

Clinical Evidence

No clinical data provided; substantial equivalence supported by mechanical test data.

Technological Characteristics

Titanium spinal fixation system; components include straight rods, outer rings, caps, and polyaxial screws. Designed for posterior implantation. Mechanical stabilization principle.

Indications for Use

Indicated for patients requiring spinal stabilization for severe spondylolisthesis (Grade 3-4 at L5-S1), unstable spinal fractures, spinal tumors, degenerative disk disease, or spinal curvatures (scoliosis/kyphoscoliosis). Applicable to thoracic, thoracolumbar, and lumbar spine (T1-S1). Suitable for children with adequate bony/soft tissue maturity.

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

• Versalok Screw Assembly

Submission Summary (Full Text)

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3/30/99

## Attachment 7

Summary

# K990708 510(k) Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: March 3, 1999 Trade Name: Titanium Versalok Screw Assembly Common Name: Spondylolisthesis Spinal Fixation Device System Predicate Device: Versalok Screw Assembly

Description/Intended Use: The Titanium Versalok Screw Assembly consists of straight rods, an outer ring, cap, and polyaxial screws, and the instruments necessary to implant this specific system. The Titanium Versalok Screw Assembly is intended to provide stabilization of the spine for various indications (see below). The device is intended to be removed after solid fusion has occurred.

A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (LS-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.

When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:

- Unstable spinal fractures (such as fracture dislocations) or instability 1. secondary to spinal tumors:
- 2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies):
- Spinal curvatures (such as idiopathic scoliosis, neuromuscular 3. scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- · Progressive, despite other forms of treatment.
- · Detrimental to cardiopulmonary function,
- · Interfering with spinal mechanics or causing severe back pain,
- or
- · Cosmetically unacceptable, progressive, and painful.

The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.

The Titanium Versalok Screw Assembly was declared substantially equivalent to other predicate or preamendment devices. Mechanical test data was provided in the application.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1999

Mr. Dan Regan Director, Clinical and Requlatory Affairs Wright Medical Technology, Inc. 5677 Airline Road 38002 Arlington, Tennessee

K990708 Re: Titanium Versalok Screw Assembly Trade Name: Requlatory Class: II Product Codes: KWP and MNH Dated: March 3, 1999 March 4, 1999 Received:

Dear Mr. Regan:

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 Requlations, 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 requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Mr. Dan Regan

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 the regulation entification" (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,

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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# Attachment 3

í

# Indications for Use Statement

## 510(k) Number (if known)

| Device Name | Titanium Versalok |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass. |
| | When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to: |
| | 1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors; |
| | 2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); |
| | 3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: |
| | <ul><li>Progressive, despite other forms of treatment,</li><li>Detrimental to cardiopulmonary function,</li><li>Interfering with spinal mechanics or causing severe back pain,</li><li>Cosmetically unacceptable, progressive, and painful.</li></ul> |
| | The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity. |
| | PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990208

Prescription Use
X
(per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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