(294 days)
Not Found
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion for conditions like spondylolisthesis, spinal stenosis, pseudarthrosis, failed fusion, or degenerative disc disease, which are therapeutic interventions.
No
The device is described as a Highgate Curved Rod System intended for unilateral screw fixation and stabilization of a spinal segment as an adjunct to spinal fusion. It is a surgical implant designed to provide structural support, not to diagnose medical conditions.
No
The device description explicitly states it 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes the Highgate Curved Rod System as a surgical implant intended for fixation and stabilization of the spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The description focuses on the physical components (rods and screws), the anatomical site of implantation (thoracolumbar spine), and the surgical purpose (stabilization as an adjunct to spinal fusion). This is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. 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 (Ti6Al4V, ASTM F136) and includes rods and screws. 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterolateral thoracolumbar spine from T6 to L5
Indicated Patient Age Range
skeletally mature patients
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)
Not Found
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
K023983 PAGE 1/1
SEP 2 2 2003
510(k) SUMMARY
| Sponsor: | Highgate Orthopaedics
One Walnut Street
Boston, MA 02108 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact
Person: | Kevin Connors, President |
| Proprietary Trade
Name: | Highgate Curved Rod System |
| Device Description: | The Highgate Curved Rod System is available in titanium
alloy (Ti6Al4V, ASTM F136) and includes rods and screws.
Screws are used to attach the rod to the thoracolumbar spine.
Rods are offered in two curvatures and have circular openings
accommodate the screws. |
| Intended Use: | The Highgate Curved Rod System is intended for unilateral
screw fixation of the anterolateral thoracolumbar spine from
T6 to L5 in skeletally mature patients. 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. |
| Materials: | The Highgate Curved Rod System components are
manufactured from titanium alloy (Ti6Al4V, ASTM F136). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the
Highgate Medial Curved Rods to be substantially equivalent
to the previously cleared Highgate Lateral Curved Rods. The
substantial equivalence is based upon equivalence in
indications/intended use, manufacturing methods,
interconnection mechanism, basic design, materials and
testing. |
1
Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized eagle emblem with three parallel lines forming the wings and body. The eagle faces to the right.
Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Connors President Highgate Orthopaedics One Walnut Street Boston, Massachusetts 02108
K023983 Re:
Trade Name: Highgate Curved Rod System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Connors:
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 vour 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.
2
Page 2 - Mr. Kevin Connors
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,
Sincerely yours,
Mark N Milkersen
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
Indications for Use Statement
510(k) Number (if known): K023983
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 Lo Lo in skeletally mature patients. 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)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Mark N Mathews
ivision of General Restorative I Neurological Devices
) Number ___ K023983
Confidential: Highgate Curved Rod System Modification