(316 days)
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS Is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scallosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS is intended for scollotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.
The anterior components of the Synthes Small Stature USS when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterclateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine-(levels 78-L5),
In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System
The Synthes Small Stature USS consists of a variety of rods, hooks, station is also, avgileble The Synthes Sthair Stature OOO Consisted of a variety of Feat, Normentation is also available to facilitate implantation of the device components.
Certain implant components from the Synthes Small Stature USS can be used to connect the se Geltain Implant components from the Synthes Synthes posterior spinal systems (USS or CerviFix).
This is a 510(k) premarket notification for a medical device (Synthes Small Stature USS), not a study report or clinical trial. Therefore, the document does not contain the requested information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth.
The document is a regulatory approval letter from the FDA, stating that the device is substantially equivalent to a predicate device already on the market. It outlines the device description, indications for use, and regulatory classification. It does not present data from any specific study proving the device meets acceptance criteria.
To answer your request, I would need a different type of document, such as a clinical study report, a scientific paper detailing performance evaluation, or a submission that includes detailed testing results.
§ 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.