Source: http://docplayer.net/20292473-June-9-2015-stryker-corporation-garry-t-hayeck-ph-d-senior-regulatory-affairs-specialist-2-pearl-court-allendale-new-jersey-07401.html
Timestamp: 2020-06-06 01:41:29
Document Index: 132743192

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803', 'art 21']

June 9, Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey PDF Free Download
June 9, Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Download "June 9, 2015. Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401"
1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey June 9, 2015 Re: K Trade/Device Name: OASYS System Regulation Number: 21 CFR Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: April 9, 2015 Received: April 10, 2015 Dear Dr. Hayeck: 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 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
2 Page 2 Garry T. Hayeck, Ph.D. forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Also, please note the regulation entitled, Misbranding by reference to premarket notification (21 CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Enclosure Sincerely yours, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
3 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K Device Name OASYS System Indications for Use (Describe) 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 (T1 -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 (C1-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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) FORM FDA 3881 (1/14) Page 1 of 2 PSC Publishing Services (301) EF
4 This section applies only to requirements of the Paperwork Reduction Act of *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. FORM FDA 3881 (1/14) Page 2 of 2
5 Stryker Spine OASYS System Traditional 510(k) Premarket Notification 510(k) Summary: OASYS System Submitter Stryker Corporation 2 Pearl Court Allendale, NJ Contact Person Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist Phone: Fax: Date Prepared March 20, 2015 Trade Name OASYS System Common Name Spinal Fixation Appliances Proposed Class Class II Classification Name, Spinal Interlaminal Fixation Orthosis, 21 CFR Codification Product Codes KWP Predicate Devices Primary Predicate: Stryker Spine OASYS System: K Device Description 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. Indications for Use When intended to promote fusion of the cervical spine and occipitocervico-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 (T1 -T3). They are not intended to be placed in the cervical spine. 2
6 Stryker Spine OASYS System Traditional 510(k) Premarket Notification 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 System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors and transition rods. Summary of Technological Characteristics Summary of Performance Data Conclusion 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 subject OASYS System shares the same materials, geometries, and fundamental scientific technologies as predicate OASYS Systems. The proposed new transition rods are identical to previously cleared OASYS transition rods with the exception that thoracolumbar section of the rod is longer in length. An engineering analysis was performed to demonstrate that the addition of the longer length transition rods does not affect the performance of the OASYS System. The devices, methodologies, and materials used in this system are equivalent to previously cleared OASYS Systems. As such, the subject system is substantially equivalent to previously cleared OASYS Systems. 3