REVERTO 55 AND 37 SHAPE MEMORY STAPLES

{0}------------------------------------------------ # 510(K) SUMMARY #### Subject 510(k) Number ________________________________________________________________________________________________________________________________________________________ # Sponsor Core Essence Orthopaedics, LLC 301 Oxford Valley Road Suite 905B Yardley, PA 19067 #### FDA Establishment Registration Number Pending #### Official Contact Shawn T. Huxel, CEO & President Core Essence Orthopaedics, LLC 301 Oxford Valley Road Suite 905B Yardley, PA 19067 Phone - (215) 310-9534 Fax - (609) 482-4957 Mobile - (908) 896-5893 # Proprietary Name reVERTOTM Shape Memory Staples #### Common Name Staple, Fixation, Bone #### Classification Name and Reference Sec. 888.3030 Single/multiple component metallic bone fixation appliances and accessories ### Regulatory Class Class II Device Product Code (Panel 87) JDR #### Date Prepared 24 May, 2007 Core Essence Orthopaedics, LLC AUG 1 5 2007 {1}------------------------------------------------ ### Brief Description of Device reVERTOTM Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process. #### Indications for Use reVERTO™ Shape Memory Staples are intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs ### Basis for Substantial Equivalence The substantial equivalence of the reVERTO Shape Memory Staples is based on the equivalence in intended use, materials, operational principals, and indications to: | DEVICE | Manufacturer | Trade Name | |---------|------------------------|-----------------| | K993714 | Biomedical Enterprises | Memograph | | K001354 | Biomedical Enterprises | OSStaple | | K051408 | Intelifuse | Stimulink | | K060014 | Intelifuse | Stimulink | | K002695 | Telos Medical | Memodyn Staples | # END OF 510(K) SUMMARY Core Essence Orthopaedics, LLC {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Core Essence Orthopaedics, LLC % Mr. Shawn T. Huxel CEO and President 301 Oxford Valley Rd. Suite 905B Yardlev. Pennsylvania 19067 AUG 15 2007 Re: K071477 Trade/Device Name: reVERTO™ 55 Shape Memory Staples and reVERTO™ 37 Shape Memory Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessorites Regulatory Class: II Product Code: JDR Dated: July 17, 2007 Received: July 18, 2007 Dear Mr. Huxel: 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 {3}------------------------------------------------ Page 2 - Mr. Shawn T. Huxel 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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Sincerely yours, Karlaue Buehup Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510 (K) NUMBER IF KNOWN: DEVICE NAME: reVERTO™ Shape Memory Staples Indications for Use: reVERTO™ Shape Memory Staples are intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs Prescription Use W AND/OR (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Yaulan Buehum for MOM (Division Sign-Off) Division of General, Restorative, and Neurological Devices Core Essence Orthopaedics, LLC Confidential 510(k) Number_K071477 Page 57 of 60