(106 days)
The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal deformities (i.e., scoliosis, kyphosis and/or lordlosis), tumor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The IMPLANET Spine System is a posterior instrumentation system. The polvaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.
The monoaxial pedicle screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3 and are available in 5.0 mm. 7.0 mm. and 8.0 mm diameters. The screws range in length from 35 to 60 mm.
The system includes both straight and pre-bent rods made of Ti6AI4V titanium alloy.
The transverse connectors are composed of Ti6AI4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.
The hooks are made of Ti6Al4V titanium alloy and are provided in multiple configurations.
The purpose of this 510(k) is to extend the ISS line to include:
- New monoaxial and polyaxial screws .
- Cobalt Chromium rods
- New Ti6Al4V titanium alloy rods ●
- Offset connector and associated offset connector screws
- Rod to rod connectors
- . New instruments
The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.
The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods. The purpose of the subject 510(k) notice is for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, to the company's cleared system.
The provided document is a 510(k) summary for the IMPLANET Spine System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, rather than presenting a clinical study or performance study with defined acceptance criteria for an AI/algorithm-driven device.
Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth establishment, MRMC study, training set size) is not applicable to this type of regulatory submission and is not present in the provided text.
The document describes a mechanical performance study and biocompatibility testing for the physical spinal implant system. It confirms that:
- Acceptance Criteria for Performance Data: The goal was to confirm that modifications "do not adversely impact mechanical strength compared to the predicate" and that the device is "biocompatible." Specific numerical acceptance criteria are not provided in this summary, but the general criteria are comparative to the predicate.
- Reported Device Performance:
- Static axial gripping capacity, static flexion/extension bending, static axial torque gripping capacity (ASTM F1798)
- Static compression bending (ASTM F1717)
- Static torsion (ASTM F1717)
- Dynamic compression bending (ASTM F1717)
- Cytotoxicity (ISO 10993-5)
- Acute systemic toxicity (ISO 10993-11)
- Results: "All results confirmed that the modifications to the device described in this submission do not adversely impact mechanical strength compared to the predicate. In addition, the device is biocompatible."
The other requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI) is specific to the evaluation of AI/algorithmic devices and is not relevant to this 510(k) submission for a physical implant system.
§ 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.