(87 days)
KWO
Not Found
No
The summary describes a mechanical implant (cervical plate system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical properties like fatigue strength.
Yes
The device is described as "intended to provide stability while allowing the cervical spine to fuse" for various indications like instability caused by trauma, degenerative disc diseases, tumors, etc., which are conditions requiring medical intervention to restore normal function.
No
The device is a cervical plate system used to provide stability during spinal fusion, not to diagnose a condition.
No
The device description explicitly states it consists of a cervical plate, locking cap, and bone screw, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed to provide mechanical stability to the cervical spine during fusion. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device consists of a plate, locking cap, and bone screw, which are all components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
This device falls under the category of a surgical implant or orthopedic device.
N/A
Intended Use / Indications for Use
The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:
- Instability caused by trauma (including fractures); .
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis . deformity;
- Instability associated with tumors; .
- Instability associated with degenerative disk diseases defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- . Instability from 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.
Product codes
KWO
Device Description
The Michelson Anterior Cervical Plate System consists of a cervical plate, locking cap and bone screw. The locking cap is preassembled onto the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Submitted testing demonstrates that the Michelson Anterior Cervical Plate System fatigue strength is comparable to a predicate device and adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Michelson Anterior Cervical Plate, Synthes CSLP System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the date FEB 1 9 1998 at the top. Below the date is a sequence of numbers and letters, specifically K974435. The text is black and the background is white. The text appears to be handwritten.
510(k) Summary
| Contact Person: | Dan Regan |
|---|---|
| Date Prepared: | February 4, 1998 |
Trade/Proprietary Name: Michelson Anterior Cervical Plate System Anterior Cervical Plate System Common Name: ORION Anterior Cervical Plate, Synthes CSLP System Predicate Device:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/Intended Use
The Michelson Anterior Cervical Plate System consists of a cervical plate, locking cap and bone screw. The locking cap is preassembled onto the plate.
·The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:
- Instability caused by trauma (including fractures); .
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis . deformity;
- Instability associated with tumors; .
- Instability associated with degenerative disk diseases defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- . Instability from 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.
Materials
All the components are made from titanium alloys (Ti-6Al-4V).
Testing Summary
Submitted testing demonstrates that the Michelson Anterior Cervical Plate System fatigue strength is comparable to a predicate device and adequate for its intended use.
1
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Mr. Dan Regan Manager, Requlatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K974435 Michelson Anterior Cervical Plate Requlatory Class: II Product Code: KWO Dated: November 21, 1997 November 24, 1997 Received:
Dear Mr. Regan:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act). to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.
FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, ----------This device system is not approved for screw " WARNING : attachment or fixation to the posterior elements -----(pedicles) of the cervical, thoracic, or lumbar spine.";
2
Page 2 - Mr. Dan Regan
- All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
- Pedicular screw fixation/attachment to the cervical, 3 . thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
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 General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Mr. Dan Regan
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 (800) 638-2041 or (301) 443-6597 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
4
C. Indications for Use of the Device
510(k) Number (if known):
Michelson Anterior Cervical Plate System Device Name:
Indications for Use:
The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:
- Instability caused by trauma (including fractures); .
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis . deformity;
- Instability associated with tumors; .
- Instability associated with degenerative disk diseases defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- Instability from 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.
(Please do not write below this line-continue on another page if needed) * * 水 * * *
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bases
Prescription Use X Or (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-7