MODIFICATION TO EBI SPINELINK SYSTEM
Device Facts
| Record ID | K982908 |
|---|---|
| Device Name | MODIFICATION TO EBI SPINELINK SYSTEM |
| Applicant | Electro-Biology, Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Aug 28, 1998 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1. When used as an anterior fixation system or as an posterior hook and sacral/ iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracy, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, so trauma, spinal stenosis, spinal deformities (scoliosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
Device Story
Spinal fixation system using interconnecting links, screws, and hooks; provides stabilization, reduction, or alignment of thoracic, lumbar, and sacral spine. Used by surgeons in clinical settings; implanted to facilitate spinal fusion. Pedicle screw use restricted to severe L5-S1 spondylolisthesis; nonpedicle use indicated for degenerative disc disease, trauma, deformities, and tumors. System components provide mechanical support to vertebral segments; intended for removal after solid fusion mass development. Benefits include spinal stabilization; risks include component fracture, loss of fixation, non-union, neurological, vascular, or visceral injury.
Clinical Evidence
No clinical data provided. Substantial equivalence based on engineering analysis and comparison of technological characteristics to predicate devices.
Technological Characteristics
Spinal fixation system components manufactured from Ti-6Al-4V ELI (ASTM F136); available with or without TiN coating. System utilizes interconnecting links, screws, and hooks for mechanical stabilization. Non-powered, mechanical device.
Indications for Use
Indicated for patients with severe spondylolisthesis (Grades 3-4) at L5-S1 requiring fusion with autogenous bone graft; nonpedicle applications for reduction, alignment, or stabilization of thoracic, lumbar, and sacral spine in cases of degenerative disc disease, trauma, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion.
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.
Predicate Devices
- EBI SpineLink™ System (K964797, K971970)
- Isola® Spine System (AcroMed Corporation)
- TSRH® Spinal System (Sofamor Danek)
Submission Summary (Full Text)
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AUG 28 1998
K982908
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## 510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.
- Submitter: Electro-Biology, Inc. 1. 6 Upper Pond Road Parsippany, NJ 07054
Contact Person: Jon Caparotta Telephone: (973) 299-9022
Date prepared: August 14, 1998
| 2. Proprietary Name: | EBI SpineLink™ System |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spondylolisthesis Spinal Fixation Device System<br>Spinal Intervertebral Body Fixation Orthosis<br>Spinal Interlaminal Fixation Orthosis |
Predicate or legally marketed devices that are substantially equivalent: 3.
- · EBI SpineLink™ System
- · Isola® Spine System AcroMed Corporation
- TSRH® Spinal System Sofamor Danek
- Description of the device: The EBI SpineLink™ System is a spinal fixation device that 4. uses interconnecting links. This submission is for the addition of an 8.5 mm screw, 18 mm link (standard and reverse) and availability of screws in 25 and 30 mm lengths.
- 5. Intended Use: The EBI SpineLink™ System has not changed the Indications for Use or fundamental scientific technology of the previously cleared EBI SpineLink™ System (K964797 and K971970). The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first saccal (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or illac screw fixation with the fusion only at L5-S1.
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K982908
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When used as an anterior fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
- Materials: The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136. 6. The components will be available with and without TiN coating.
- Comparison of the technological characteristics of the device to predicate devices: There are 7. no significant differences between the EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Engineering analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence infringement lingation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355,)]
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Image /page/2/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 symbol of three human profiles facing to the right, represented by flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1998
Mr. Jonas Wilf Electro-Biology Inc. 6 Upper Pond Road 07054 Parsippany, New Jersey
Re : K982908 EBI SpineLink™ System Requlatory Class: II Product Codes: MNH, KWP, and KWQ Dated: August 14, 1998 Received: August 18, 1998
Dear Mr. Wilf:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system
subject to the general controls provisions of the Act and the limitations identified below.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III
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device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) havinq severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
#### WARNINGS :
- . When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended . for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- . Potential risks identified with the use of this device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
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See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
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. ಕ್ಕಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
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### Page 4 - Mr. Jonas Wilf
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally markered predicate device results in a classification for your device and 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Statement of Indications for Use:
The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe sportylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.
W hen used as an anterior fixation system or as an posterior hook and sacral/ iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracy, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, so trauma, spinal stenosis, spinal deformities (scoliosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign (Division Signeral Restorative Devices
Division of General Restorative Box 510(k) Number - 1883 908
