(35 days)
The Cortera™ Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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 stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera™ Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera™ Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.
The Cortera Spinal Fixation System (Cortera System) is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or the sacral spine. The Cortera System consists of screws, rod-to-rod connectors, lateral offset connectors, rods, locking set screws and associated reusable manual surgical instruments for an open or minimally invasive surgical approach. The screws, rod-to-rod connectors, lateral offset connectors, and set screws are manufactured from titanium alloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy or cobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants are available in a variety of sizes to accommodate individual patient anatomy and are provided non-sterile. A variety of these implant configurations were previously covered in K221403.
The Cortera System rods may be used in connection with Streamline Cross Connectors, cleared by FDA in K192800. The Streamline Cross Connectors accept various rod diameters and are appropriate for use with Cortera System 5.5 mm diameter rod-based systems. These cross connectors will keep their original cleared trade name.
Here's a breakdown of the acceptance criteria and the study information for the Cortera™ Spinal Fixation System, based on the provided FDA 510(k) summary:
This device is a spinal fixation system, which is a physical implant, not an AI/software device. Therefore, many of the requested criteria (like ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training/test set sample sizes for AI) are not applicable. The documentation focuses on engineering and material performance rather than diagnostic accuracy or human interpretation.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cortera™ Spinal Fixation System are implicitly derived from adherence to established FDA guidance documents and international standards for medical devices, particularly those for spinal fixation systems, biocompatibility, and reprocessing. The "reported device performance" is the conclusion that the device "complies with its predetermined specifications and the applicable guidance document" based on the verification and validation (V&V) activities.
| Acceptance Criteria Category | Specific Criteria (Implicit via adherence to standards) | Reported Device Performance and Study Conclusion |
|---|---|---|
| Reprocessing | - Compliance with FDA Guidance Document: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2024). |
- Compliance with AAMI/ANSI ST79: 2017, Am1: 2020, Am2: 2020, Am3: 2020, Am4: 2020 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities).
- Compliance with ISO 17665-1: 2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
- Achievement of a sterility assurance level (SAL) of 10-6 for validated steam sterilization parameters (Pre-vacuum, 132°C (270°F), 4 minutes exposure, 30 minutes dry time). | "Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document."
Specifically, the device achieved an SAL of 10-6 with a recommended dry time of 30 minutes (a change from the predicate's 40 minutes, which was apparently validated as acceptable). |
| Biocompatibility | - Compliance with FDA Guidance Document: "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" (September 8, 2023). - Compliance with ISO 10993-1: 2018 (Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process). | "Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document." |
| Bench Performance Testing| - Compliance with FDA Guidance Document: "Spinal System 510(k)s" (May 3, 2004). - Adherence to materials standards: ASTM F136-13, ASTM F899-20, ASTM F1537-20, ASTM F2063-18.
- Adherence to mechanical testing standards: ASTM F1717-21 (Spinal Implant Constructs in a Vertebrectomy Model), ASTM F1798-21 (Evaluating Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants). | "Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document."
"Verification and validation activities were conducted to establish the performance and safety characteristics of the Cortera System. The results of these activities demonstrate that the Cortera System is substantially equivalent to the predicate device when used in accordance with its intended use and labeling."
This implies the mechanical properties and material composition meet the relevant ASTM standards for spinal implants. |
Study Details (Not applicable for this type of device submission)
Given that this is a 510(k) submission for a physical medical device (spinal fixation system), rather than a diagnostic AI/software device, many of the requested details about studies, experts, and ground truth are not relevant in the context of this document. The submission relies on bench testing and adherence to consensus standards and guidance documents to demonstrate substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance: This refers to the number of physical components (screws, rods, connectors) tested in bench studies. The document does not specify exact numbers but indicates that various configurations and sizes were included. Data provenance is implied to be from laboratory bench testing conducted by the manufacturer, Xtant Medical Holdings, Inc.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by objective engineering measurements against defined specifications and recognized industry standards (e.g., ASTM standards for material strength and fatigue).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is measured objectively according to engineering test protocols.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and performance is based on objective engineering and materials science standards (e.g., mechanical strength, fatigue life, biocompatibility, and reprocessing efficacy) measured through laboratory bench testing.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
§ 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.