(22 days)
When used as a posterior pedicle screw fixation system, the Synthes USS is 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudoanthrosis).
In addition, the Synthes USS is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature 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, the Synthes USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), deqenerative 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.
In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System.
Anterior components of the USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scollosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).
Anterior components of the USS consists of Stainless Steel or Titanium Universal Spinal threaded rods, Universal Spinal unthreaded rods and Universal Spinal side-opening screws (except 4.2 mm) with a collar and nut, staples, washers, and parallel connectors. The Universal Spinal screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a Universal Spinal Rod.
Posterior components of the USS are composed of Stainless Steel or Titanium and consist of rods, hooks, side-opening screws with a collar and nut, variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transyerse bars, and parallel connectors, Schanz screws, and clamp with posterior nut.
The provided document is a 510(k) Premarket Notification for a medical device called the "Synthes Universal Spinal System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance through clinical studies with acceptance criteria in the way a Pre-Market Approval (PMA) would.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: This document doesn't define quantitative performance metrics or present data against them.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or training set details: These are all aspects of a clinical study or performance evaluation that are not present in this 510(k) submission.
Instead, the document asserts substantial equivalence by:
- Stating: "This system is substantially equivalent to previously cleared Synthes spinal systems and is supported by testing which satisfies the requirements of thoracolumbar and sacral fixation." (Page 0)
- Listing: The components of the device (rods, screws, hooks, etc.) and their materials (Stainless Steel or Titanium). (Page 0)
- Defining: The specific indications for use for both posterior pedicle screw fixation, posterior non-pedicle screw fixation, and anterior components. (Page 0, and reiterated on Page 3)
The FDA's response letter (Pages 1-2) confirms that they have "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
In summary, as this is a 510(k) submission for substantial equivalence, the document focuses on comparing the new device to existing predicate devices, rather than establishing and reporting against new performance acceptance criteria through the detailed study methods you've outlined.
§ 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.