POLARUS CONNECT

{0}------------------------------------------------ 510(k) Summary Manufacturer: Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124 Date: Submitted by: Company Contact 5885 NW Cornelius Pass Road Hillsboro, OR 97124 June 1, 2013 Orgenix LLC 111 Hill Road +1-646-460-2984 Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124 Brittany Cunningham Regulatory Specialist 2 Phone: (503) 207-1467 Fax: (503) 520-9618 Mr. Donald W. Guthner Douglassville, PA 19518 +1-484-363-5879 (FAX) component, metal composite Acumed Polarus® Connect System F382, ASTM F543 and ASTM F1264 OCT 1 0 2013 Secondary Contact: Classification Name: Common/Usual Name: Proprietary Name: Performance standards: Classification no .: 21 CFR 888.3030 LXT, HRS, HSB - Humerus Intramedullary Nail and Plate System Class II The Acumed Polarus Connect System components and constructs were mechanically tested to the following standards - ASTM Appliance, fixation, nail/blade/plate combination, multiple Humerus Intramedullary Nail and Plate Fixation System Substantial Equivalence: Substantial equivalence for the Acumed Polarus Connect System is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: - . K051735 Smith & Nephew PERI-LOC Locking Bone Plates and Locking Bone Screws for the upper extremity - K091425 NMB Medical Applications. Ltd Quantum IM . Composite Nailing System । 09 {1}------------------------------------------------ # K131636 | | K012655 Acumed Congruent Bone Plate System K951740 Acumed Intramedullary Fixation Rod | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Devices: | The subject device is substantially equivalent to previously cleared devices listed above. | | Device Description: | The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. | | | The Polarus® Connect System also includes instruments to facilitate placement of implants. | | Intended Use: | The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus. | | Summary of<br>Technological<br>Characteristics | The Acumed Polarus® Connect System is manufactured from Titanium alloy complying with ASTM F136 and PEEK complying with ASTM F2026. The devices provide stabilization of humerus fractures. | | Non-Clinical Testing | The Acumed Polarus® Connect System was tested according to the following standards:<br>ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates<br>ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws<br>ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices<br>The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices. | | Conclusion | The information discussed above demonstrates that the Acumed Polarus® Connect System devices are effective and perform as well as or better than the predicate devices. Based upon the similarities of the Polarus® Connect System and the predicate devices studies, the safety and the effectiveness of the Polarus® Connect System is substantially equivalent to the predicate devices referenced. | ・ . {2}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 10, 2013 Acumed. LLC Ms. Brittany Cunningham Regulatory Specialist 2 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124 Re: K131636 Trade/Device Name: Polarus * Connect Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT. HRS. HSB Dated: September 26, 2013 Received: September 30, 2013 Dear Ms. Cunningham: 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 Image /page/2/Picture/11 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of a government organization, possibly related to health or human services. The symbol in the center consists of three curved lines that resemble a stylized representation of a person or a flame. The logo is in black and white and has a simple, clean design. {3}------------------------------------------------ ## Page 2 - Ms. Brittany Cunningham 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/MedicalDcvices/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/ResourcesforYou/Industry/default.htm. Sincerely yours. # Erin | Keith for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # K131636 #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page 510(k) Number (if known) K131636 #### Device Name Polarus® Connect #### Indications for Use (Describe) The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus. Type of Use (Select one or both, as applicable) 区 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 (9/13)