(156 days)
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The Precision Surgery Limited Variable and Fixed Cervical Plate System includes plates and screw components. There are three types of plates available, two variable and one fixed. Primary and rescue screws are available.
The provided text is a 510(k) summary for the "Precision Surgery Limited Variable and Fixed Cervical Plate System." This document is a premarket notification for a medical device and describes its intended use, materials, and substantial equivalence to existing devices. It does not contain information about acceptance criteria, study designs, sample sizes, expert ground truth, or performance metrics typically found in clinical or performance studies.
Therefore, I cannot provide the requested information from the given text.
The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices, meaning it argues that the new device is as safe and effective as a legally marketed device. This typically involves comparing design, materials, and intended use, rather than conducting new performance studies against specific acceptance criteria.
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FEB 1 2 2004
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Attachment VIII 510(k) Summary
| Sponsor: | Precision Surgery Limited318 Pheasant CourtFond du Lac, WI 54935Phone: 920.223.0547, Fax: 920.223.0551 |
|---|---|
| ContactPerson: | Kamaljit S. Paul, MD |
| ProprietaryTrade Name: | Precision Surgery Limited Variable and Fixed Cervical Plate System |
| DeviceDescription: | The Precision Surgery Limited Variable and Fixed Cervical Plate Systemincludes plates and screw components. There are three types of plates available,two variable and one fixed. Primary and rescue screws are available. |
| Intended Use: | The Precision Surgery Limited Variable and Fixed Cervical Plate System isintended for anterior screw fixation of the cervical spine. These implants havebeen designed to provide stabilization as an adjunct to cervical fusion.Indications for the use of this implant system include degenerative disc diseasedefined as neck pain of discogenic origin with the degeneration of the discconfirmed by history and radiographic studies, spondylolisthesis, trauma,spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. |
| WARNING: The Precision Surgery Limited Variable and Fixed Cervical PlateSystem is not intended for screw attachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbar spine. | |
| Materials: | The Precision Surgery Limited Variable and Fixed Cervical Plate componentsare manufactured from titanium alloy (ASTM F136). |
| SubstantialEquivalence: | Documentation was provided which demonstrated the Variable and FixedCervical Plate System to be substantially equivalent to previously cleareddevices. The substantial equivalence is based upon equivalence in indicationsfor use, anatomic sites, performance and material of manufacture. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its wing and tail feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Precision Surgery Limited C/o Ms. Karen E. Warden, MEBE 8202 Sherman Road Chesterland, Ohio 44026
Re: K032815
Trade/Device Name: Variable and Fixed Cervical Plates Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 29, 3003 Received: January 6, 2004
Dear Ms. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (sec above) into either class II (Special Controls) or class HI (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the fiederal Register.
Please be advised that I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Karen E. Warden, MEBE
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a logally premarket notification. The PDA midnig of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (11 CFR Part 801). phcase If you desire specific advice for your de new case. Also, please note the regulation enitled. comaci the Office of Comphaned at (537) eart 807.97). You may obtain "Misbranding by reference to premance notifications of the Act from the Division of Small other general information on your responsents at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Pressurer Pressuredth/dsma/dsmamain.html
Sincerely yours,
L. Mark McMullerson
Celia M. Witten, Ph.D., M.D. Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Attachment III
510(k) Number:
Device Name: Variable and Fixed Cervical Plates
Indications for Use:
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degeneralive disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Variable and Fixed Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
for Mark A. Miller
Division of General, I astorative. and Neurological Devices
510(k) Number K032815
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use ____________
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.