(27 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 and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- 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 Oasys System can be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.
This submission is intended to address a line extension to Stryker Spine OASYS™ System. The line extension includes a new range of Titanium alloy axial & parallel rod-to-rod connectors, standard hooks & rods as well as new CP Titanium rods. The new range of Titanium alloy axial and parallel rod-to-rod connectors will also facilitate the linkage between Stryker Spine OASYS™ and SR90D Systems.
The provided text describes a 510(k) submission for a line extension to the Stryker Spine OASYS™ System. It focuses on the mechanical and design equivalence to a predicate device rather than clinical performance or acceptance criteria based on device performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance (especially clinical performance with metrics like sensitivity, specificity, or reader improvement) is not present in the provided document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" appear to be based on the substantial equivalence to a predicate device (Stryker Spine OASYS™ System (K032394)) with respect to:
- Indications for Use: The subject components share the same indications for use as the predicate device.
- Material: The subject components share the same material (Titanium alloy) as the predicate device.
- Basic Design Concepts: The subject components share basic design concepts as the predicate device.
- Mechanical Properties: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."
Therefore, the reported "performance" is that the new components are comparable or equivalent to the predicate device in these aspects. No specific numerical performance metrics are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was a 510(k) for a line extension of an existing spinal fixation system, relying on mechanical equivalence and material properties rather than clinical performance data from a test set of patient cases. No clinical test set data or provenance is mentioned.
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. No clinical test set was described that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was described.
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 is a medical device (spinal fixation system), not an AI/software device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (spinal fixation system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this submission was based on the specifications and performance of the predicate device, demonstrated through mechanical testing for "comparable mechanical properties."
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is mentioned.
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SEP 2 1 2005
Page 1 of 3
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the OASYSTM System
| Name and Address of the Sponsorof the 510(k) Submission: | Stryker Spine2 Pearl CourtAllendale, NJ 07401 |
|---|---|
| Contact Person: | Simona VoicRegulatory Affairs Project Manager |
| Date of Summary Preparation: | August 24, 2005 |
| Proprietary Name: | Stryker Spine OASYS™ System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,21 CFR §888.3050Pedicle Screw Spinal System21 CFR §888.3070 |
K032394 Stryker Spine OASYS® System Predicate Device Information: The Stryker Spine OASYS™ System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and are provided non-sterile. The Stryker Spine OASYSTM System can be linked to the Stryker Spine Xia® Spinal System via the rod-to-rod connectors.
{1}------------------------------------------------
K052317 Page 2 of 3
Description of Device Modification
This submission is intended to address a line extension to Stryker Spine OASYS™ System. The line extension includes a new range of Titanium alloy axial & parallel rod-to-rod connectors, standard hooks & rods as well as new CP Titanium rods. The new range of Titanium alloy axial and parallel rod-to-rod connectors will also facilitate the linkage between Stryker Spine OASYS™ and SR90D Systems.
Indication for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Stryker Spine OASYS (M System is intended for:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- . 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.
Intended Use:
The Stryker Spine OASYS™ System can be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.
{2}------------------------------------------------
Statement of Technological Comparison:
The subject components share the same indications for use, material, and basic design concepts as that of the predicate device: Stryker Spine OASYS™ System (K032394). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, NJ 07401
Re: K052317
Trade Name: Stryker Spine OASYSTM System (Line Extension) Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: August 24, 2005 Received: August 25, 2005
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Ms. Simona Voic
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
So Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K052317
Device Name: Stryker Spine OASYSTM System
Indications For Use:
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 and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- 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 Oasys System can be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.
x x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K052317 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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.