(23 days)
The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy, with certain subcomponents manufactured from shape memory alloy (Nitinol - Niti). The devices may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified plates to the ORION® Anterior Cervical Plate System.
This 510(k) summary for the ORION® Anterior Cervical Plate System focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a novel AI/software medical device.
Therefore, much of the requested information (like expert qualifications, adjudication methods, multi-reader studies, standalone performance, and training set details) is not applicable or present in this type of submission. This document pertains to a physical medical device (an anterior cervical plate system) and its modifications, not a software algorithm.
However, I can extract the relevant information that is present:
1. Table of "Acceptance Criteria" and Reported Device Performance:
For a physical device modification like this, "acceptance criteria" are typically related to mechanical performance, biocompatibility, and substantial equivalence to a predicate device. The "reported device performance" is a demonstration that these criteria are met through testing or comparison.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The modified plates use materials equivalent to the predicate. | The implant components will be made from titanium alloy, with certain subcomponents manufactured from shape memory alloy (Nitinol - Niti); consistent with predicate device. |
| Functional Equivalence: The modified plates perform similarly to the predicate plates. | A risk analysis and comparative data were provided in support of this notification, demonstrating functional equivalence to the predicate ORION® Anterior Cervical Plates (K973854) and other predicate devices (K792352, K802462). |
| Safety and Effectiveness Equivalence: The modified plates are as safe and effective as the predicate. | The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, implying similar safety and effectiveness. |
| Intended Use: The device maintains the same indications for use as the predicate. | The ORION® Anterior Cervical Plate System is intended for the same anterior interbody screw fixation of the cervical spine and temporary stabilization during spinal fusions for various conditions as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
This document does not describe a clinical study with a "test set" in the context of AI/software performance. Instead, the "test set" would refer to mechanical testing or material characterization samples. The document does not specify the sample sizes for these tests. Data provenance is not described in detail, but it would typically originate from in-vitro biomechanical testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For a physical device, "ground truth" would be established by engineering specifications, material and mechanical properties testing, and clinical outcomes of the predicate device. These typically do not involve a "number of experts" in the same way an AI diagnostic study would.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically for evaluating human or AI interpretations of data. For a physical device, compliance is determined by meeting engineering standards and comparative data to predicates.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, this type of study was not done. An MRMC study is relevant for comparing diagnostic performance, often involving human readers with and without AI assistance. This submission is for a physical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this submission is substantial equivalence to legally marketed predicate devices. This is established by comparing:
* Materials (Titanium alloy, Nitinol)
* Intended Use
* Design principles (anterior cervical plate for interbody screw fixation)
* Performance (implied through risk analysis and comparative data, likely mechanical testing data)
* Safety profile (implied by equivalence to predicates)
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set for an AI model.
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ORION® Anterior Cervical Plate System Special 510(k) Summary September 2004
| I. | Company: | Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133 |
|---|---|---|
| Contact: | Richard TreharneSr. Vice President Regulatory Affairs | |
| II. | Product Name: | ORION® Anterior Cervical Plate System |
| Classification Name:Classification No./Code: | Spinal intervertebral body fixation orthosis888.3060 - KWO |
.
- The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone III. plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy, with certain subcomponents manufactured from shape memory alloy (Nitinol - Niti). The devices may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified plates to the ORION® Anterior Cervical Plate System.
- IV. The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
- V. The subject ORION® Anterior Cervical Plates were claimed to be substantially equivalent to the predicate ORION® Anterior Cervical Plates cleared in K973854 (SE 3/16/98), as well as to the Cervical Spine Locking Plate and Plates for Cervical Vertebra (K792352, K802462) manufactured by Synthes, the latter being the original predicate device for the ORION Anterior Cervical Plate System. A risk analysis and comparison data were provided in support of this notification.
000088
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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 an abstract symbol resembling a stylized eagle or bird with three wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 7 = 2004
Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K042499
Trade/Device Name: ORION® 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 13, 2004 Received: September 14, 2004
Dear Dr. Treharne:
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 - Richard W. Treharne, PhD
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 (301) 594-4659. 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. Millan
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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August 2004
Page __ 1__ of ___ 1__
510(k) Number (if known): _ Kouz4999
ORION® Anterior Cervical Plate System Device Name:
Indications For Use:
The ORION® Anterior Cervical Plate System is intended for anterior interbody screw The system is indicated for use in the temporary fixation of the cervical spine. stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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)
b. Mark N. Mulkerson
and Neurological Devices
510(k) Number K042499
900150
Page 1 of 1
§ 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.