(64 days)
The Uniplate Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Uniplate Anterior Cervical Plate System consists of an assortment of plates and screws.
The Uniplate Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This 510(k) summary describes a spinal implant device, not a device that measures or reports performance metrics like accuracy, sensitivity, or specificity. Therefore, the information requested in the prompt (acceptance criteria, study details, human reader improvement, etc.) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than on performance metrics obtained from human subject studies or algorithmic evaluations.
Here's why the specific questions cannot be answered from the provided text:
- No reported performance data: The "PERFORMANCE DATA:" section states "Performance data were submitted to characterize the Uniplate Anterior Cervical Plate System" but does not provide any specific metrics or results. This is common for mechanical devices where testing often involves benchtop mechanical evaluations rather than clinical performance metrics.
- No AI/Algorithm component: The device is a physical spinal implant (plates and screws). It does not involve any artificial intelligence, algorithms, or image interpretation components that would require a test set, ground truth, expert consensus, or MRMC studies.
- Nature of the device: This is a Class II medical device, specifically a "Spinal Intervertebral Body Fixation Orthosis." The regulatory pathway for such devices often involves demonstrating mechanical performance and biocompatibility, along with substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy.
Therefore, a table of acceptance criteria and reported device performance with the requested details cannot be generated from the given text.
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| X.510(k) Summary | NOV 2 3 2004 |
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| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 |
| CONTACT PERSON: | Jennifer Mooney |
| DATE PREPARED: | September 17, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Uniplate Anterior Cervical Plate System |
| PREDICATE DEVICES: | DePuy Spine Acroplate Anterior Cervical PlateSystem (cleared as the Top Cervical SpineStabilization System) K914362 |
| DEVICE DESCRIPTION: | Uniplate Anterior Cervical Plate System consists of anassortment of plates and screws.The Uniplate Anterior Cervical Plate System alsocontains Class 1 manual surgical instruments andcases that are considered exempt from premarketnotification. |
| INTENDED USE: | The Uniplate Anterior Cervical Plate System isintended for anterior cervical intervertebral bodyfixation. This system is indicated for patients in whichstability is desired following anterior cervical fusion forthe indications listed below. The intended levels fortreatment range from C2 to T1.Indication includes symptomatic cervical spondylosis,trauma, fracture, post-traumatic kyphosis or lordosis,tumor, degenerative disc disease (defined asdiscogenic pain with degeneration of the discconfirmed by history and radiographic studies), spinalstenosis, re-operation for failed fusion, or instabilityfollowing surgery for the above indications. |
| MATERIALS: | Manufactured from ASTM F-136 implant gradetitanium alloy. |
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PERFORMANCE DATA:
Performance data were submitted to characterize the Uniplate Anterior Cervical Plate System.
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Image /page/2/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, wing-like shapes that resemble a bird in flight or a stylized human figure.
Public Health Service
NOV 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K042544
Trade/Device Name: Uniplate Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 17, 2004 Received: September 20, 2004
Dear Ms. Starowicz:
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 (OS) 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. Sharon Starowicz
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 Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milleson
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 IV.
Koy2544 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Uniplate Anterior Cervical Plate System Device Name:
Indications For Use:
The Uniplate Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
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) |
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K042554
DePuy Spine, Inc. રાજસ
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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.