ISOLA TWISTER CONNECTOR
Device Facts
| Record ID | K965046 |
|---|---|
| Device Name | ISOLA TWISTER CONNECTOR |
| Applicant | Acromed Corp. |
| Product Code | MNH · Orthopedic |
| Decision Date | Mar 14, 1997 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid fusion is attained. Benefit of spinal fusions utilizing any pedicle screw fixation 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. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery. As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
Device Story
Two-piece spinal fixation component; consists of slotted transverse member and V-groove body with mating splines; allows intraoperative sagittal alignment in 7° increments; slotted design provides surgical latitude for screw placement; machine-threaded screw locked to connector via nut; used by surgeons in spinal fusion procedures; provides mechanical stabilization of spine segments; intended for removal after solid fusion.
Clinical Evidence
Bench testing only; static and fatigue testing demonstrated performance consistent with previously cleared components.
Technological Characteristics
Two-piece connector assembly; material: ASTM F 136 titanium alloy; spline-based joint for 7° sagittal alignment increments; slotted transverse member; threaded screw/nut locking mechanism.
Indications for Use
Indicated for grade 3 or 4 spondylolisthesis (L5-S1) with autologous bone graft; non-pedicle screw indications include spondylolisthesis, degenerative disc disease, deformities (scoliosis, lordosis, kyphosis), tumor, fracture, and failed surgery (T1-ilium/sacrum).
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
- ISOLA Twister Connector (stainless steel)
- AcroMed Slotted Connectors
Related Devices
- K962645 — ISOLA TWISTER CONNECTOR · Acromed Corp. · Oct 22, 1996
- K965102 — ACROMED PEDICLE SCREW · Acromed Corp. · May 8, 1997
- K964304 — OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY · Osteonics Corp. · Jan 17, 1997
- K963045 — SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM · Synthes (Usa) · Feb 13, 1997
- K231807 — primaLOK SP Interspinous Fusion System · Wenzel Spine, Inc. · Aug 15, 2023
