(29 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYSTM System is intended for:
- Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondvlolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation ●
- Atlanto/axial fracture with instability .
- Occipitocervical dislocation .
- Revision of previous cervical spine surgery .
- Tumors .
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Stryker Spine OASYSTM System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.
This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of two rod-to-rod connectors (axial and parallel versions) used to link the 3.5mm OASYS™ System rods with the Xia® 4.5 Spinal System rods (510(k) numbers #K050461 and #K060361). The Xia® 4.5 Spinal System rods will retain their original cleared name.
This document is a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. It does not describe a study proving a device meets acceptance criteria in the traditional sense of a clinical or performance study with numerical targets. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition and validated mechanical properties.
Therefore, the requested information elements related to clinical study design, ground truth, expert adjudication, sample sizes for test/training sets, and comparative effectiveness studies are not applicable in this context.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The primary "acceptance criterion" for this 510(k) is demonstrating equivalent mechanical properties to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Equivalent mechanical properties to the predicate OASYS™ System (K032394) | "Testing has demonstrated that the additional rod-to-rod connector components have equivalent mechanical properties to the predicate OASYS™ System (K032394)." |
| Same indications for use as the predicate device | "Both the new components and the existing system components are intended to address the same indications for use." |
| Made from the same materials as the predicate device | "Both the new components and the existing components are made from the same materials." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a Special 510(k) submission for a line extension, not a clinical study involving human or animal subjects that would require a "test set" and associated data provenance in this manner. The "testing" mentioned refers to mechanical property validation on the device components themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. See point 2. The "ground truth" here is the established mechanical properties of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for spinal fixation components, not an AI or imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for spinal fixation components, not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established mechanical properties of the predicate device, as determined by engineering standards and testing, and the material composition of the predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this type of device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" in the context of this type of device submission. The "ground truth" for demonstrating substantial equivalence (as described in point 7) would have been established through engineering design, material specifications, and standardized mechanical testing processes.
§ 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.