(57 days)
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
The SCS Claris Spinal Screws Types V, G and E are available in outer (major) diameters ranging from 5.5 to 9.5mm in 1mm increments and cancellous lengths ranging from 25 to 55mm in 5mm increments.
The provided 510(k) summary (K011807) describes the SCS Claris Spinal Screws Types V, G, and E. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
Instead, the summary focuses on establishing substantial equivalence to a previously cleared device (SCS Claris Spinal Screws Types V, L, and R). Substantial equivalence is determined based on:
- Equivalence in indications/intended use: The new screws are intended for the same clinical applications.
- Manufacturing methods: The production processes are similar.
- Interconnection (attachment) mechanism: How the screws integrate with other spinal instrumentation is consistent.
- Basic design: The fundamental structural characteristics are alike.
- Materials: The materials used (stainless steel and titanium alloy) are the same as the predicate device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions 2-9, as those pertain to a performance study that is not detailed in this 510(k) summary. The FDA's letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the devices are substantially equivalent (for the indications for uses stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the approval is based on equivalence to a predicate device, not on a new performance study demonstrating specific acceptance criteria.
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AUG - 7 2001
510(k) SUMMARY of Safety and Effectiveness
| Sponsor: | OrthoTec, LLC9595 Wilshire Blvd. Suite 502Beverly Hills, CA 90212Phone: (310) 557-2000 & (310) 273-1500Fax: (310) 843-9500 |
|---|---|
| Contact Person: | Patrick Bertranou, MD |
| Proprietary Trade Name: | SCS Claris Spinal Screws Types V, G and E |
| Device Description: | The SCS Claris Spinal Screws Types V, G and E are available in outer (major) diameters ranging from 5.5 to 9.5mm in 1mm increments and cancellous lengths ranging from 25 to 55mm in 5mm increments. |
| Intended Use: | When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis). |
| When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis) | |
| When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. | |
| Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis). | |
| Materials: | The SCS Claris Spinal Screws are manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy (ASTM F138 / ISO 5832-3). |
| Substantial Equivalence: | Documentation was provided which demonstrated the SCS Claris Spinal Screws Types V, G and E to be substantially equivalent to the previously cleared SCS Claris Spinal Screws Types V, L and R. the substantial equivalence is based upon equivalence in indications/intended use, manufacturing methods, interconnection (attachment) mechanism, basic design and materials. |
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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 bird-like symbol with three curved lines representing wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
AUG - 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Bertranou President OrthoTec, LLC 9595 Wilshire Boulevard, Suite 502 Beverly Hills, California 90212
Re: K011807 Trade Name: SCS Claris Spinal Screws Types V, G and E Regulatory Class: II Regulatory Class: 11
Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 Product Code: MNI, MNH, KWP, KWQ Dated: July 23, 2001 Received: July 25, 2001
Dear Mr. Bertranou:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Security from total is substantially equivalent (for the indications for uses and above and we have determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrossure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Device Trinendments, or and Cosmetic Act (Act). You may,
accordance with the provisions of the Federal Food, Drug, and Cosment of the Asst. The accordance will the provisions of the reachar root controls provisions of the Act. The general therefore, market the device, subject to the generats for annual registration, listing of devices, controls provisions of the Act mende requirentibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into such additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additional controls. Title (Premarket Approval), it may of subject to case of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 895. A substainanty cquirement, as set forth in the Quality System Regulation (OS) for Manufacturing I ractice requirements as a 3 cc 820) and that, through periodic (QS) Medical Devices. General regulation (FDA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumplia inspections, the Food and Drug Administration (1 Disy Internation . In addition, FDA may publish Comply with the GMT Tegalation may researce in the Federal Register. Please note: this further alliouncements concerning your consission does not affect any obligation you might response to your premarker nonnoution such success 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 This letter will anow you to begin marketing your device of your device to a legally marketed notheation. The I Dri miding of basianter open device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Patrick Bertranou
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, (Jease 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,
Molluscuton
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
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Indications for Use Statement
510(k) Number (if known):
Device Name: SCS Claris Spinal Sustem Screws
Indications for Use:
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
When used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are:
having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)
(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
Bmithelenko than
and Neurological De
510(k) Number K011807
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.