ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure, with three profiles facing right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 27, 2015 Alliance Partners, LLC % Mr. Kellen Hills Quality & Regulatory Consultant Orchid Design. A Division of Orchid Orthopedic Solutions 4600 East Shelby Drive, Suite 1 Memphis. TN 38118 Re: K141123 > Trade/Device Name: Alliance Spine RAAS Cranial Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: February 20, 2015 Received: February 25, 2015 Dear Mr. Kellen Hills, 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Carlos L. Pena -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141123 Device Name RAAS Cranial Plating System Indications for Use (Describe) The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas. Type of Use (Select one or both, as applicable) | <label><input checked="true" type="checkbox"/> For Activities Under CEE 301.5(c)</label> | <label><input type="checkbox"/> For Site Controls Under CEE 301.5(d)</label> | |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL 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 PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ | (a)(1) | Submitted By: | Alliance Partners, LLC<br>(dba Alliance Spine™)<br>14206 Northbrook Dr.<br>San Antonio, TX 78232 | | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Date: | February 20, 2015 | | | | Contact Person: | Tim M. Lohnes<br>Senior Regulatory Consultant<br>Orchid Design | | | | Phone:<br>Fax: | 203-922-0105<br>203-922-0130 | | | (a)(2) | Proprietary Name: | RAAS Cranial Plating System | | | | Common Name: | Bone Plates, Bone Fixation Fasteners | | | | Classification Names and References: | 882.5320 - Preformed alterable<br>cranioplasty plate<br>882.5250 - Burr hole cover<br>882.3560 - Cranioplasty plate fastener | | | | Product Codes: | GWO, GXR, HBW | | | (a)(3) | Predicate Devices: | Stryker-NEURO II (K031659)<br>OsteoMed-Low Profile Neuro (K111176) | | | | SUBJECT DEVICE | PREDICATE DEVICES | | | Manufacturer | Alliance Spine | Stryker | OsteoMed | | System Name | RAAS Cranial<br>Plating System | Neuro 2 Cranial Plate<br>System | Low Profile Neuro<br>Fixation System | | 510(k) | Subject | K031659 | K111176 | | Product Codes | GWO, GXR, HBW | JEY, HWC | GWO, GXR | | Indications for Use | The RAAS Cranial<br>Plating System is<br>indicated for<br>osteotomy,<br>craniotomy,<br>cranial fractures,<br>and<br>reconstruction of<br>non-load bearing<br>cranial areas. | The Stryker Leibinger<br>Universal Neuro<br>System is a low-<br>profile plate and<br>screw system<br>intended for<br>osteotomy,<br>craniotomy,<br>stabilization and rigid<br>fixation of craniofacial<br>fractures and<br>reconstruction of<br>non-load bearing<br>areas. | The OsteoMed<br>LowProfile Neuro<br>Fixation System is<br>indicated for use in<br>ostemtomies,<br>fractures or<br>reconstruction of<br>cranial bones.<br>Implants and drills<br>are single use only. | | Sterilization | End User (steam) | Non-sterile and sterile | Not specified | | Shelf Life | n/a | Not specified | Not specified | | Implant Material: | | | | | Plates and<br>Burr Hole Covers - | ASTM F136 | CP Ti | ASTM F136/F67 | | Mesh – | ASTM F67 | CP Ti | ASTM F136/F67 | | Screws - | ASTM F136 | Ti Alloy | ASTM F136 | | Thickness: | | | | | Plates & Burr Hole<br>Covers - | 0.5mm | 0.6 and 0.5mm | 0.25 to 1.0mm | | Mesh - | 0.3 and 0.6mm | 0.1, 0.2, 0.3 and<br>0.6mm | 0.25 to 1.0mm | | Surface<br>Treatment:<br>Plates & Burr Hole<br>Covers | None | Type III Anodized | Not specified | | Surface<br>Treatment: Mesh | Type III Anodized | Type III Anodized | Not specified | | Screws - type | Self-tapping,<br>drilling, and<br>rescue | Self-tapping, drilling,<br>and rescue | "Auto Drive" and<br>rescue | | Screws:<br>diameter/length | 1.5 x 4 & 5mm,<br>1.7 x 5 & 6mm | 1.5mm x 4, 5 & 6mm<br>1.7mm x 4mm | 1.6mm x 4, 5, 6 & 8mm, 1.9mm x 4, 5, 6 & 8mm | | Surface<br>Treatment: Screws | Type III Anodized | Type III Anodized | Not specified | ### Device Description: (a)(4) The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification. {4}------------------------------------------------ The Alliance Spine™ RAAS Cranial Plating System is indicated for osteotomies, craniotomy, cranial fractures, and reconstruction of non-load bearing cranial areas. - Technological Characteristics: (a)(6) {5}------------------------------------------------ ### (b)(1) Non-clinical testing: | Test | Test Method Summary | Results | |--------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Static Axial Compression | Worst case Burr Hole plates<br>were subjected to loading as<br>described in ASTM F382. | Peak load and stiffness values<br>were acceptable based on<br>intended use and predicate data.<br>Subject device expected to<br>perform similarly to predicate. | | Insertion/Removal Torque | Worst case screws were<br>inserted into and then<br>removed from a test block as<br>described in ASTM F543. | Driving torque values were<br>acceptable based on intended<br>use and predicate data. Subject<br>device expected to perform<br>similarly to predicate. | | Ultimate Torque | Worst case screws were fixed<br>below the head and subjected<br>to loading as described in<br>ASTM F543. | Peak torque values were<br>acceptable based on intended<br>use and predicate data. Subject<br>device expected to perform<br>similarly to predicate. | | Axial Pullout | Worst case screws were<br>inserted to a fixed depth and<br>subjected to loading as<br>described in ASTM F543. | Peak load values were acceptable<br>based on intended use and<br>predicate data. Subject device<br>expected to perform similarly to<br>predicate. | ## Clinical testing: (b)(2) Clinical testing was not required to demonstrate substantial equivalence in this premarket notification. ## (b)(3) Conclusions: Based on the information provided in this premarket notification, we believe that the subject RAAS Cranial Plating System demonstrates substantial equivalence and has a safety and effectiveness profile that is similar to the identified predicate devices.