(30 days)
The Inertia™ Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a cervical intervertebral fusion devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ded for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion devices the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar soine, from L2-S1. in skeletally mature patients who have had six months of -nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for Use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).
When used as a vertebral body replacement devices are indicated for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues. and to restore the height of a collapsed vertebral body. The device is intended for use with autograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).
The Facet Fixx System is intended to spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are interior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the spinous process. through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The Facet Fixx System is intended for bilation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
· Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
- · Degenerative disease of the facets with instability
- · Trauma (i.e. fracture or dislocation)
- · Spondylolisthesis
- · Spondylolysis
· Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
The Struxxure™ System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), turnor, pseudarthrosis or failed previous fusion.
The Inertia Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.
The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column: The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
The Facet Fixx™ System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
Struxxure TM consists of plates and screws in a variety of sizes. Plates from 1to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.
Nexxt Spine spinal systems implants are manufactured from a variety of medical grade materials including titanium alloy (Ti-6Al-4V ELI) per ASTM F136, CP Titanium (Grade 2 or 4) per ASTM F67, Zeniva® ZA-500 polyetheretherketone per ASTM F-2026 or tantalum per ASTM F-560.
The provided text is a 510(k) summary for several spinal systems (Inertia, Honour, Facet Fixx, Struxxure) from Nexxt Spine. This document focuses on demonstrating substantial equivalence to predicate devices, primarily by showing identical technological characteristics, and does not include performance data or a study on acceptance criteria for the device itself.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data from this document. The section "Performance Data" on page 3 of 3 explicitly states: "Performance data is not provided in this submission."
This means the document does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample size for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used or sample size/ground truth establishment for training sets.
§ 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.