(213 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys 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 (Tl -T3). 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 (C I-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.
The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.
This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System. The proposed line extension consists of the transition rod.
The acceptance criteria for the Stryker Spine OASYS® System - Transition Rod LE, and the study used to demonstrate its meeting of these criteria, are derived from the Special 510(k) Premarket Notification K111719.
This submission focuses on a line extension to an existing device, introducing a "transition rod." For such modifications, the primary acceptance criteria revolve around demonstrating substantial equivalence to predicate devices in terms of materials, design, mechanical performance, and indications for use. This is typically achieved through comparative mechanical testing rather than clinical trials or AI-specific performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate devices in: - Static Compression Bending - Fatigue Compression Bending - Static Torsion Bending - Fatigue Torsion Bending | Performed testing per ASTM F1717. Results demonstrated substantial equivalence to a predicate system. |
| Material | Substantial equivalence to predicate devices. | Components fabricated from Titanium alloy, CP Titanium, and Vitallium®. These materials are commonly used in spinal fixation systems and are consistent with predicate devices. |
| Design | Substantial equivalence to predicate devices. | The transition rod is a line extension to the existing OASYS™ System, implying a design consistent with the existing system but adapted for its specific function. |
| Indications for Use | Substantial equivalence to predicate devices. | Indications for Use are consistent with those of the predicate OASYS™ System for promoting fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical "sample size" in the context of clinical data or patient cases, as this was a mechanical performance study rather than a study on clinical outcomes or diagnostic accuracy. The "test set" here refers to the physical samples of the device (transition rods) and potentially predicate device components that were subjected to the mechanical tests. The exact number of samples tested per condition (static, fatigue, bending, torsion) is not provided but would typically involve a statistically relevant number of physical samples as per ASTM F1717.
- Data Provenance: The data is prospective in the sense that the mechanical tests were conducted specifically for this 510(k) submission. It is laboratory-based testing. There is no indication of country of origin for clinical data, as no clinical data was presented for this specific submission to demonstrate AI performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a mechanical testing study, not a study requiring expert consensus for ground truth on clinical images or patient outcomes. The "ground truth" for mechanical testing is established by the standardized test methods (ASTM F1717) and the physical properties of the materials and designs under controlled conditions.
4. Adjudication Method for the Test Set
Not applicable. There was no need for an adjudication method as no subjective assessments or disagreements between experts were involved. The results of the mechanical tests were objectively measured according to the ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a mechanical spinal fixation system, not an AI software device intended to assist human readers in interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done as this is not an AI algorithm but a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was based on objective mechanical test results performed according to the specified ASTM standard (ASTM F1717). This standard dictates the methods for evaluating mechanical performance (static and fatigue compression bending, static and fatigue torsion bending) of spinal implant assemblies. The performance of the subject device (transition rod) was then compared to that of predicate systems to demonstrate substantial equivalence against these established mechanical benchmarks.
8. The Sample Size for the Training Set
Not applicable. As this device is a mechanical spinal implant and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this device.
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JAN 1 9 2012
Stryker Spine OASYS® System - Transition Rod LE
KII1719
Special 510(k) Premarket Notification
Special 510(k) Summary OASYS® System - Transition Rod LE
Stryker Spine OASYS™ System Proprietary Name: Common Name: Spinal Fixation Appliances Class II Proposed Regulatory Class: 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis 87 KWP: Appliance, Fixation, Spinal Interlaminal Device Product Code: Tiffani D. Rogers Official Contact : Regulatory Affairs Manager Stryker Spine t: 201-760-8206 f: 201-760-8406 email: tiffani.rogers(@stryker.com Susan Frank, Esq. For Information Contact: Regulatory Consultant 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8100 Fax: (201) 760-8464 Email: Susan.Frank(@Styker.com Date Summary Prepared: June 15, 2011 Stryker Spine OASYS® System: K032394, K052317, Predicate Device Identification K062853, K072568. K080143, K093670, K101183
Predicate Device Description
The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks,
l
Page 1 of 3
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connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.
Description of Device Modification
This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System. The proposed line extension consists of the transition rod.
Intended Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys 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 (TI -T3). 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 (C I-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.
page 2 of 3
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KII1719
Special 510(k) Premarket Notification
Statement of Technological Comparison:
Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static and Fatigue Compression Bending, and Static and Fatigue Torsion Bending, testing, per ASTM F1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2012
Stryker Spine % Ms. Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K111719
Trade/Device Name: Stryker Spine OASYS® System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 23, 2011 Received: December 27, 2011
Dear Ms. King:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{4}------------------------------------------------
Page 2 – Ms. Soraya King
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
yours,
M.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K11719
Device Name: Line Extension to the Stryker Spine OASYS® Systém
Indications for Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys 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 (Tl -T3). 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 (C I-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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sion of Surgical Orthopedic, and Restorative Devices
Page_l_of_l_
KIII719 510(k) Number_
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.