OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
Device Facts
| Record ID | K964304 |
|---|---|
| Device Name | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY |
| Applicant | Osteonics Corp. |
| Product Code | MNH · Orthopedic |
| Decision Date | Jan 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components. The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below: For non-pedicular use: - Long and short curve scoliosis, - Vertebral fracture or dislocation, - Spondylolisthesis, - Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). For pedicular use: - When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
Device Story
Spinal fixation accessory; connects longitudinal spinal constructs across spine midline. Increases resistance to lateral loads, rotation, and torsional forces. Comprised of two top-loading transverse connectors, set screws, and a transverse connector bar. Used by surgeons in spinal fusion procedures. Provides structural stability to spinal rod constructs; facilitates fusion by immobilizing vertebral segments.
Clinical Evidence
Bench testing only; static and fatigue testing performed to demonstrate mechanical and endurance properties.
Technological Characteristics
Materials: ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Design: Top-loading transverse connector assembly for spinal rod crosslinking. Non-sterile, single-use.
Indications for Use
Indicated for patients with long/short curve scoliosis, vertebral fracture/dislocation, spondylolisthesis, or degenerative disc disease. Pedicular use restricted to severe spondylolisthesis (Grades 3-4) at L5-S1, requiring autogenous bone graft, fixation to lumbar/sacral spine, and removal after fusion. Not for pedicle placement above L3.
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
- Osteonics® Spinal System (Osteonics Corp.)
- TSRH™ Spinal System (Sofamor Danek)
- GDLH™ Posterior Spinal System (Sofamor Danek)
- ISOLA Spinal System (Acromed)
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- K181995 — Chiral Surgical Pedicle Screw System · Chiral Surgical · Sep 20, 2018
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- K052404 — DENALI DEFORMITY SYSTEM · K2m, LLC · May 23, 2006
