(256 days)
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Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion and is indicated for conditions like spondylolisthesis, spinal stenosis, and degenerative disc disease, all of which aim to treat medical conditions.
No
The device, the Highgate Curved Rod System, is described as intended for stabilization of a spinal segment as an adjunct to spinal fusion, using rods and screws. Its function is to provide structural support, not to diagnose medical conditions, although its use is indicated based on pre-existing diagnoses from radiographic studies.
No
The device description explicitly states that the Highgate Curved Rod System includes rods and screws made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Highgate Curved Rod System Function: The Highgate Curved Rod System is a surgical implant intended to provide mechanical stabilization to the spine as an adjunct to spinal fusion. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure and the purpose of the implant within that procedure.
- Device Description: The description details the materials and components of the implantable device (rods and screws).
While the intended use mentions "radiographic studies" for diagnosis, the device itself is not performing the diagnostic test. The radiographic studies are used to determine the patient's condition and the need for the surgical intervention using the Highgate Curved Rod System.
N/A
Intended Use / Indications for Use
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T9 to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
Product codes
KWQ
Device Description
The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anterolateral thoracolumbar spine from T9 to L5
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
MAR 1 2 2002
Sponsor:
Proposed Proprietary Trade Name: Device Description:
Indication/Intended Use:
Materials:
Substantial Equivalence:
Performance Characteristics:
510(k) SUMMARY of Safety and Effectiveness
K012045
page 1 of 1
Highgate Orthopaedics One Walnut Street Boston, MA 02108
Highgate Curved Rod System
The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
The Highgate Curved Rod System is intended for fixation of the anterolateral unilateral screw thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
The Highgate Curved Rod System components are manufactured from titanium alloy (Ti6A14V, ASTM F136).
The Highgate Curved Rod System was determined to be substantially equivalent to several commercially available systems.
Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Highgate Orthopaedics c/o Ms. Karen E. Warden, MEBE Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141
Re:
Highgate Curved Rod System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 13, 2002 Received: February 20, 2002
Dear Ms. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and entirent date of the Medical Device Amendments, or to conmerce proc to Hiley 20, 2017, in accordance with the provisions of the Federal Food, Drug, de MCS that have been rocuse in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 1 ou may, dicierore, market the Act include requirements for annual registration, listing of The general vontable proving 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 II your device is classified (500 above) and Existing major regulations affecting your device can may be subject to such additions, 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 I loase be advisou that I Dr o resuarted on our device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must of any I cachi statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, laboring (21 CFR Part 820); and if applicable, the electronic 10.11 m the quality bysellis (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Karen E. Warden, MEBE
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'le begin maing of substantial equivalence of your device to a legally promatics notication: "The PDF Intentigstification 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 and 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 859. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outer general 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,
Mule N Mule
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
3
4. Indications for Use Statement
510(k) Number (if known): K012045
Device Name: Highgate Curved Rod System
Indications for Use:
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Und 0(k) Number
L. Mark Miller
Sign-Off vision of General. Restorative and Neurological Devices
Prescription Use (Per 21 CFR 801.109)
Confidential: Highgate Curved Rod Premarket Notification
OR
012045