(23 days)
Not Found
No
The summary describes a spinal fixation system with new screw components and focuses on mechanical equivalence testing, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "promote fusion of the cervical spine and occipito-cervico-thoracic junction" and to "provide stabilization to promote fusion following reduction of fracture/dislocation or trauma," which are therapeutic purposes.
No
The device is described as a system intended to promote fusion and provide stabilization in the spine, not to diagnose a condition.
No
The device description explicitly states it adds "new polyaxial screw components" to an existing system, indicating it is a hardware device (spinal implants).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system designed to promote fusion and provide stabilization in the cervical and upper thoracic spine. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a system of screws, hooks, and rods, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an implantable surgical device.
N/A
Intended Use / 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 also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.
Product codes (comma separated list FDA assigned to the subject device)
MNI, KWP
Device Description
This 510(k) adds new polyaxial screw components Description of Device Modification (non-biased and cancellous styles) to the existing OASYSTM System.
The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipito-cervico-thoracic junction (Occiput -T3), occipital, upper thoracic spine (T1-T3), cervical/upper thoracic (C1 -T3) spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032394, K052317, K062853, K030103, K041203
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
OCT 5 " 2007
Line Extension to the Stryker Spine OASYS™ System
Special 510(k) Premarket Notification
072568
Special 510(k) Summary: Line Extension to the Stryker Spine OASYSTM System
| Proprietary Name: | OASYST™ System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| 21 CFR 888.3070 (b)(1): Pedicle Screw Spinal Syster | |
| 21 CFR 888.3050: Spinal Interlaminal Fixation | |
| Orthosis | |
| Device Product Code: | MNI: Orthosis, Spinal Pedicle Fixation |
| KWP: Appliance, Fixation, Spinal Interlaminal | |
| For Information contact: | Simona Voic |
| Regulatory Affairs Project Manager | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8145 | |
| Fax: (201) 760-8345 | |
| Email: Simona.Voic@stryker.com | |
| Date Summary Prepared: | September 11, 2007 |
| Predicate Devices | Stryker Spine's OASYST™ System - 510(k)#: |
| K032394, K052317, & K062853 | |
| DePuy Spine, Inc. Summit OCT Spinal System - | |
| 510(k)#: K030103 & K041203 |
1
Intended Use
Special 510(k) Premarket Notification
This 510(k) adds new polyaxial screw components Description of Device Modification (non-biased and cancellous styles) to the existing OASYSTM System.
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
2
Line Extension to the Stryker Spine OASYS™ System
Special 510(k) Premarket Notification
thoracic (C1 -T3) spine.
The Stryker Spine OASYS™ System™ can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.
Summary of the Technological Characteristics
The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
OCT 5 2007
Re: K072568
Trade/Device Name: OASYS™ System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP. MNI Dated: September 11, 2007 Received: September 12, 2007
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, listing 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. 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
4
Page 2 - Ms. Simona Voic
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Line Extension to the Stryker Spine OASYSTM System
Special 510(k) Premarket Notification
Indications for Use
K0725b8 510(k) Number (if known):
Device Name: Line Extension to the 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 t 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 also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.
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)
harbare Buchm
Division of Gener and Neurological Devices
510(k) Number K072568