EBI SPINELINK SYSTEM
Device Facts
| Record ID | K964533 |
|---|---|
| Device Name | EBI SPINELINK SYSTEM |
| Applicant | Electro-Biology, Inc. |
| Product Code | MNH · Orthopedic |
| Decision Date | Apr 9, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The EBI SpineLink™ System (severe spondylolisthesis indication) 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.
Device Story
Posterior pedicle spinal system; consists of fixed and polydirectional pedicle/sacral screws, interconnecting links, lock nuts, and washers. Used by surgeons in clinical settings for spinal stabilization during fusion procedures. Device provides mechanical fixation to lumbar and sacral spine; intended for removal following solid fusion mass development. Benefits include stabilization of severe spondylolisthesis.
Clinical Evidence
Bench testing only; no clinical data provided. Bench testing compared system performance against predicate devices to verify functional requirements.
Technological Characteristics
Materials: Ti-6Al-4V ELI (ASTM F136); optional TiN coating. Components: fixed/polydirectional pedicle/sacral screws (5.5-7.5 mm diameter), interconnecting links, lock nuts, washers. Mechanical fixation system.
Indications for Use
Indicated for patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint requiring fusion with autogenous bone graft. Device fixation limited to L3-S1 or iliac screw placement.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Webb-Morley Spine System (Electro-Biology, Inc.)
- TSRH® Spinal System (Sofamor Danek)
- Dyna-Lok® Spine System (Sofamor Danek)
- Isola® Spine System (AcroMed Corporation)
- VSP® Plating System (AcroMed Corporation)
- KSF Spinal Fixator (Tornier SA)
Related Devices
- K043484 — LANX SPINAL FIXATION SYSTEM · Lanx, LLC · May 16, 2005
- K021335 — MONARCH SPINE SYSTEM · Depuyacromed · Jul 11, 2002
- K141253 — NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM · New Era Orthopaedics, LLC · Jan 9, 2015
- K230482 — Swedge Pedicle Screw Fixation System · Spinal Resources, Inc. · Mar 23, 2023
- K191655 — MEGAFIX® Pedicle Screw Spinal System · Seohancare Co., Ltd. · Mar 6, 2020
