MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
Applicant
Advanced Spine Fixation Systems, Inc.
Product Code
KWP · Orthopedic
Decision Date
Apr 13, 1999
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3050
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass. The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiocraphic studies), soondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and multi-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required. For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/iliac/lamina attachment only. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.
Device Story
The Varigrip system is a spinal fixation device used for non-cervical spine stabilization. It consists of components (CGT-SL and CGT-SL-15) designed for attachment to the spine to treat conditions such as degenerative disc disease, scoliosis, and fractures. The device is intended for use by surgeons in a clinical/surgical setting. It provides mechanical stabilization to facilitate spinal fusion. The system includes titanium components for patients with metal sensitivities. The device is intended to be removed following the development of a solid fusion mass.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Spinal fixation system components; titanium construction; intended for non-cervical spine attachment; mechanical fixation via pedicle screws, sacral screws, and sublaminar wiring.
Indications for Use
Indicated for patients with severe spondylolisthesis (grades 3-4) at L5-S1 requiring fusion with autogenous bone graft; also indicated for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and revision surgery in the non-cervical spine. Titanium components indicated for patients with stainless steel sensitivity.
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1999
Advanced Spine Fixation Systems, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Saulsalito Irvine, California 92606
K990845 Re:
Trade Name: Modification to K954770 - Varigrip device components numbered CGT-SL and CGT-SL-15 Regulatory Class: II Product Codes: KWP and MNH Dated: March 12, 1999 Received: March 15, 1999
Dear Mr. Holland:
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 your 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 (QS) 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.
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Page 2 - Mr. Greg Holland
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, 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 toll-free number (800) 638-2041 or at (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
> 14 11:14 13:43: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enclosure
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Special 510(k): Device Modification – Advanced Spine Fixation Systems, Inc.
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Verifix System Device Name:
Indications For Use:
The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass.
The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiocraphic studies), soondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and multi-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/iliac/lamina attachment only. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorathe Datens K990845
510(k) Number
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
April 6, 1999
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Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
