(30 days)
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
- The ZODIAC™ Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). - The ZODIAC™ Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- In addition, the ZODIAC™ Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The ZODIAC™ Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are offered in titanium alloy, Ti-6Al-4V ELI (ASTM F 136). System rods are also available in commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for stainless steel (ASTM F 138) system components.
The ZODIAC™ Spinal Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device might.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context. The "study" here is primarily a performance data study to characterize the physical properties of the device, specifically the stainless steel components, and show they are equivalent to the previously cleared titanium alloy version.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The stainless steel components must demonstrate properties (e.g., mechanical strength, durability, biocompatibility) equivalent to the titanium alloy components of the predicate devices (K033090 and K042673). | Performance data were submitted to characterize the ZODIAC™ Spinal Fixation System manufactured from stainless steel, implying that these data supported its equivalence to the previously cleared titanium alloy versions. (Specific numerical data are not provided in this summary but would have been part of the full 510(k) submission). |
| Safety and Effectiveness Equivalence: The stainless steel system, when used for the stated indications, must be as safe and effective as the predicate titanium alloy system. | Substantial equivalence was claimed for the stainless steel system based on its similarity to the predicate devices (K033090 and K042673). The FDA's clearance (K051286) indicates that this claim was accepted. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the summary. This would refer to the number of components or constructs tested in engineering bench studies, not patient data.
- Data Provenance: Not applicable in terms of country of origin for patient data. The "data" are results from mechanical and material testing conducted on the device components. This would typically be laboratory data.
- Retrospective or Prospective: Not applicable. This refers to engineering test data, not clinical patient data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth in this context refers to established material science and biomechanical engineering standards used to evaluate device performance.
- Qualifications of Experts: Not applicable. Evaluation would be against established engineering standards and specifications.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Decision-making is based on comparing test results against established engineering standards and specifications for substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This is a medical device for spinal fixation, not a diagnostic imaging or AI-assisted interpretation device. The study type is focused on mechanical and material properties.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Not applicable. There is no algorithm or AI component to this physical medical device. The "performance data" refers to the mechanical and material testing of the physical components.
7. Type of Ground Truth Used:
- Ground Truth: Engineering and material science standards, biomechanical testing criteria, and established performance characteristics of the predicate titanium alloy ZODIAC™ Spinal Fixation System. The "ground truth" for the new stainless steel components is that their performance must meet or exceed the performance of the predicate device to ensure substantial equivalence.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. There is no AI or machine learning component requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable. No training set is involved.
§ 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.