(213 days)
The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondvlolisthesis.
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and
- failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.
The Firebird Spinal Fixation Systems include temporary, multiple component systems comprised of a variety of non-sterile and sterile single use components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and illum by means of screw or hook fixation to the non-cervical spine. The systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws.
A subset of the systems' components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.
The JANUS Fenestrated Screws are a family of modular, cannulated bone screws manufactured from Ti-6AL-4V ELI or Ti-6AL-4V ELI with HA (Hydroxyapatite) Coating that features a fenestrated distal end. The JANUS Fenestrated Screws are designed to be used in an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.
The provided text is a 510(k) summary for the Orthofix Firebird Spinal Fixation Systems, specifically focusing on the addition of JANUS Fenestrated Screws. The document details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information about acceptance criteria, the specific study design (e.g., sample size, data provenance, number of experts, adjudication methods for a test set, MRMC studies, or standalone algorithm performance) for establishing ground truth, or details about training sets.
The only "performance data" mentioned is mechanical performance testing on the JANUS Fenestrated Screws, comparing them to a predicate device. This is a non-clinical test, not a study involving human subjects or AI-assisted interpretation of medical images.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, as the document does not contain this information in the context of the requested details (e.g., AI performance, expert reads, ground truth for image interpretation).
The document is solely focused on establishing the substantial equivalence of a physical medical device (spinal fixation system) based on its mechanical properties and intended use compared to similar predicate devices, not on the performance of a software or AI component that interprets data or images.
§ 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.