(87 days)
The Pioncer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document is a 510(k) summary for the Pioneer Anterior Cervical Plate System, a medical device for spinal intervertebral body fixation. The content provided does not describe an AI/ML powered device, and therefore does not contain information about acceptance criteria or specific studies to prove performance in the context of an AI/ML device.
The document discusses the device description, intended use, and comparison to predicate devices for a determination of substantial equivalence to already legally marketed devices. It also includes the FDA's decision letter regarding market clearance.
Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.
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510(k) Summary
- PIONEER SURGICAL TECHNOLOGY SPONSOR: 375 River Park Circle Marquette, MI 49855 (906) 226-4812 Contact: Jonathan M. Gilbert
Pioneer Anterior Cervical Plate System DEVICE NAME:
Spinal Intervertebral Body Fixation Orthosis, CLASSIFICATION NAME: Class II. Product code KWQ.
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The Pioneer Anterior Cervical Plate System DESCRIPTON consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The Pioneer Anterior Cervical Plate System is INTENDED USE: intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history radiographic studies), spondylolisthesis, and (i.e., fracture or dislocation), spinal trauma stenosis, deformities or curvatures (i.e., scoliosis, kyphosis. and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. -
Comparisons of device performance data, PERFORMANCE AND materials, indications and design/function to SE DETERMINATION: predicate devices were provided in making a determination of substantial equivalence.
Synthes CSLP - K971883, K945700, K000536; PREDICATE Stryker Reflex/Tether Plate & Screws - K040261; DEVICE(S): Depuy Acromed PEAK system - K971730; Depuy Motech Acromed - DOC Cervical Plate system -K982443; Depuy Spine - Swift Anterior Červical Plate System - K040655; Aesculap ABC K000486.
Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
Pioneer Surgical Technology
Confidential
043066
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
Re: K043066
Trade/Device Name: Pioneer Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 5, 2004 Received: November 8, 2004
Dear Mr. Gilbert:
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 (see above) into either class II (Special Controls) or class III (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 Federal Register.
Please be advised that FDA'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 – Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace Eacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Milliken
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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Indications for Use
K043066 510(k) Number (if known): PIONEER ANTERIOR CERVICAL PLATE SYSTEM Device Name: The Pioncer Anterior Cervical Plate System is intended for Indications For Use: THE i loncer init fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or (1.0., nuclures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mach A Milleen
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043066
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Pioneer Surgical Technology Premarket Notification
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Confidential 11/11/04-rev B. 11/4/04-rev A
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§ 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.