(90 days)
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in 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. kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Idiopathic scoliosis.
- Kyphotic deformities of the spine.
- Paralytic scoliosis and/or pelvic obliquity.
- Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity.
- Vertebral fracture or dislocation.
- Tumors.
- Spondylolisthesis.
- Stenosis.
- Pseudarthrosis.
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1cm from any major vessel.
This submission is a line extension to the Synergy Spinal System to add new 6.35 Polaris components, which may be used with the 6.35mm components of the Synergy™ Spinal System in order to build various types of spinal constructs. The new components include various types of bone screws and bone hooks.
This 510(k) premarket notification for the Synergy Spinal System (6.35 Polaris) is a line extension and does not report a clinical study on human subjects to determine the effectiveness or safety of the device. Instead, the submission relies on mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, many of the typical clinical study criteria are not applicable in this context.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices through technological characteristics and mechanical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials of the new components are the same as or similar to predicate devices. | The document states: "The technological characteristics (material, design and sizing) of the Synergy 6.35 Polaris components are the same as, or similar to, the predicate devices." |
| Design and Sizing Equivalence: Design and sizing of the new components are the same as or similar to predicate devices. | The document states: "The technological characteristics (material, design and sizing) of the Synergy 6.35 Polaris components are the same as, or similar to, the predicate devices." |
| Mechanical Performance Equivalence: The new components meet or exceed the performance of predicate devices in relevant mechanical tests. | The document states: "Based upon the mechanical testing, the Synergy Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market." While specific performance values are not listed in this summary, the FDA's clearance implies that the mechanical testing demonstrated acceptable performance relative to the predicates. |
| Intended Use and Indications Equivalence: The new components have the same or similar intended use and indications as predicate devices. | The document clearly lists the indications for use, which are consistent with existing spinal fixation systems and are being presented as falling within the scope of the predicate devices. It states: "The Synergy Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications..." |
| No New Issues of Safety or Effectiveness: The new components do not introduce new safety or effectiveness concerns. | The document states: "...and do not present any new issues of safety or effectiveness." This is a key declaration for 510(k) clearance. |
Study Details (Mechanical Testing, Not Clinical)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this 510(k) summary. For mechanical testing, this would refer to the number of components or constructs tested.
- Data Provenance: The testing would have been conducted in a laboratory setting, likely by the manufacturer (Biomet Spine), using standardized test methods for spinal implants. This is not "clinical" data provenance (e.g., country of origin of data, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical testing, "ground truth" is established by adherence to recognized ASTM or ISO standards for mechanical testing of spinal implants, not by expert consensus on clinical data. The "experts" would be engineering and quality control professionals overseeing the testing.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods like "2+1" are relevant for clinical endpoints adjudicated by medical experts. For mechanical testing, results are quantitative and compared against pre-defined engineering specifications or predicate device performance.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a mechanical device submission. MRMC studies are for evaluating the diagnostic performance of imaging devices or algorithms with human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant.
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The type of ground truth used:
- Mechanical Specifications/Predicate Device Performance. The "ground truth" for this type of submission is whether the mechanical properties (e.g., strength, fatigue life, stiffness) of the new components meet established engineering specifications and are comparable or superior to the predicate devices, as verified by standardized mechanical testing.
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The sample size for the training set:
- Not Applicable. This is a physical device, and there is no "training set" in the context of an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.