(26 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to provide temporary stability to the cervical spine until fusion occurs, which directly treats conditions like degenerative disc disease, trauma, and tumors.
No
The device is described as an anterior cervical plating system designed to provide temporary stability to the cervical spine until fusion occurs. It acts as an internal splint and does not perform any diagnostic functions like measuring, analyzing, or interpreting physiological data.
No
The device description explicitly states the system consists of physical components: plates, bone screws, and locking screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- ALINE™ System Function: The ALINE™ Anterior Cervical Plating System is a surgical implant designed to provide mechanical support and stability to the cervical spine during the healing process of a spinal fusion. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The description clearly states its purpose is to provide temporary stability and act as an internal splint, which is a structural and mechanical function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.
Product codes
KWO
Device Description
The ALINE TM Anterior Cervical Plating System is utilized to provide post-operative stabilization until fusion of the cervical spine has eventuated. Essentially, the plating system acts as an internal splint that carries a portion of the load until the process of healing is complete.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ALINE™ Anterior Cervical Plating System (K943523)
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
BEC 30 1998
스가 . ! - --------------------------------------------------------------------------------------------------------------------------------------------------------------------
Anterior Cervical Plating System
K9821342
United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856
Karen F. Jurczak CONTACT PËRSON:
Summary of Safety and Effectiveness
DATE PREPARED: December 1, 1998
CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis
COMMON NAME: Cervical Bone Plate System
PROPRIETARY NAME: ALINE 14 Anterior Cervical Plating System
PREDICATE DEVICES: ALINE™ Anterior Cervical Plating System (K943523)
DEVICE DESCRIPTION: The ALINE TM Anterior Cervical Plating System is utilized to provide post-operative stabilization until fusion of the cervical spine has eventuated. Essentially, the plating system acts as an internal splint that carries a portion of the load until the process of healing is complete.
- The ALINE™ Anterior Cervical Plating System is designed INTENDED USE: to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.
- MATERIALS: The Aline Cervical Plating system consists of Ti-13-13 plates, bone screws, and locking screws.
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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 stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEC 30 1998
Ms. Karen F. Jurczak Associate. Corporate Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K984342
Trade Name: Aline™ Anterior Cervical Plating System Regulatory Class: II Product Code: KWO Dated: December 2, 1998 Received: December 4, 1998
Dear Ms. Jurczak:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 Register. 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.
This letter will allow you to begin marketing your device as described in your 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,
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Page 2 - Ms. Jurczak
permits your device to proceed to the market.
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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, Cussill a
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
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Anterior Cervical Plating System
K98 4342
Indications for Use
510(k) Number (if known):
ALINE™ Anterior Cervical Plating System Device Name:
Indications For Use:
The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and turnors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X | OR Over-The-Counter |
|---|---|---|
| Use: | ||
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984342 |
|---|---|
| --------------- | --------------------------------------------------------- |