(62 days)
The Firebird Spinal Fixation System is intended for posterior, noncervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
The Firebird Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body bv means of screw . fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The Firebird Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System as indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
The Orthofix Firebird Spinal Fixation System is a Class III preamendment device (Pedicle screw spinal system, 21 CFR 888.3070) designed for posterior, non-cervical pedicle fixation as an adjunct to fusion.
Here's an analysis of the acceptance criteria and supporting evidence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Substantial Equivalence (Overall Safety and Effectiveness) | "The Firebird Spinal Fixation System were shown to be substantially equivalent to previously cleared devices with respect to intended use, design, function, materials, and performance." | Special K130176 Summary |
| Mechanical Performance (Rod Connectors) | "The Orthofix Firebird Spinal Fixation System proposed rod connectors are substantially equivalent to the predicate devices based on axial grip and torque verification, FEA simulation, and material characterization." | Mechanical Testing, FEA Simulation, Material Characterization (detailed results not provided in summary) |
| Material Compatibility | "Titanium alloy per ASTM F136 and Cobalt-Chrome per ASTM F1537." | Material Specification/Testing |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify sample sizes for mechanical testing or FEA simulations, nor does it indicate the provenance of any data beyond general material specifications. This submission is for a Special 510(k), which typically relies heavily on comparison to a predicate device and may not require extensive new testing if modifications are minor and proven equivalent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This 510(k) summary is for a spinal fixation system, not an AI or imaging device that would typically involve human expert ground truth establishment for diagnostic accuracy. Therefore, this information is not applicable and not provided.
4. Adjudication Method for the Test Set
As this is not an AI or imaging device requiring human expert review for diagnostic accuracy, an adjudication method is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human interpretation is a key component, often with and without AI assistance. This device is a surgical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (algorithm only) was not done. This is not an AI-driven device. The "performance" assessment refers to the mechanical and material characteristics of the implant itself, not an algorithm's output.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established through:
- Material Specifications: Adherence to established ASTM standards (ASTM F136 for titanium alloy and ASTM F1537 for cobalt-chrome).
- Mechanical Performance Standards: Verification against established industry standards or predicate device performance for axial grip and torque.
- Engineering Principles: Finite Element Analysis (FEA) simulation.
8. The Sample Size for the Training Set
This is not applicable. This submission concerns a physical medical device (spinal implant), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no AI training set for this 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.