ARROW Reverse Shoulder long keel and short keel glenoid base

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 20, 2015 Fournitures Hospitalieres Industrie Ms. Patricia Donnard Regulatory Affairs Manager Zi De Kernevez- 6 rue Nobel 29000 Quimper France Re: K142778 Trade/Device Name: ARROW® Reverse Shoulder long keel and short keel glenoid base Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: February 17, 2015 Received: February 19, 2015 Dear Ms. Donnard: 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 {1}------------------------------------------------ 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/Resourcesfor You/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/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, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 4. Indications for Use 510(k) Number (if known): K142778 ## Device Name: ARROW® Reverse Shoulder long keel and short keel glenoid base This device is composed of the following elements: A metal-back long keel glenoid base and a metal-back short keel glenoid base. These devices are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193. Indications for Use: The ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation. Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR Over the counter Use: No (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) Page 1 of 1 {3}------------------------------------------------ #### 5. 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92. Date prepared: September 11th 2014 The assigned 510(k) number is: K 142778 Fournitures Hospitalières industrie 5-1. Applicant: 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13 5-2. Company Contact: Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95 5-3. Product : ARROW® Reverse Shoulder long keel and short keel Trade name: glenoid base Common name: Shoulder prosthesis ARROW® Reverse Shoulder long keel and short keel Classification: glenoid base components are included in the following classifications: Shoulder joint metal/ polymer semi-constrained cemented prosthesis Product code: PHX Regulation: 21 CFR 888.3660 Class: II ## 5-4. Predicate/ Legally Marketed Devices: Information on devices to which substantial equivalence is claimed: | Manufacturer: | Fournitures Hospitalières industrie | |--------------------|-------------------------------------| | Device Trade Name: | ARROW® Reverse Shoulder System | | 510 (K): | K112193 | | Manufacturer: | Aston Medical | | Device Trade Name: | DUOCENTRIC® Reversed | | 510 (K): | K103251 | | | | {4}------------------------------------------------ #### 5-5. Device Description: The ARROW® Reverse Shoulder long keel and short keel glenoid base consist of a metal-back glenoid base, used with bone screws for fixation and assembled with previously cleared glenosphere. These components are used in total reverse prosthesis and are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193. The bone fixation screws are cleared in K112193. The ARROW® Reverse Shoulder long keel and short keel glenoid base is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193)). #### 5-6. Indications for Use/ Intended Use: As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents): The ARROW® Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation. #### 5-7. Comparison of Technological Characteristics: The ARROW® Reverse Shoulder long keel and short keel glenoid base and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities: - they are made out of the same materials (titanium alloy), - they are available in similar ranges of sizes, ı - they bear design features similarities. - #### 5-8. Performances: The ARROW® Reverse Shoulder long keel and short keel glenoid base was tested according to cyclic mechanical protocol. After the testing was completed, it was determined that the ARROW® Reverse Shoulder long keel and short keel glenoid base performances were substantially equivalent to those of the selected predicate devices. {5}------------------------------------------------ Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. #### 5-9. Substantial Equivalence: The substantial equivalence of our products, when compared to the selected predicate devices, has been established following manufacturers' commercial documents, 510(k) submission's information available on FDA's website as well as conformance to standards in force. The analysis of these technical data allows us to submit the ARROW® Reverse Shoulder long keel and short keel glenoid base as being substantially equivalent to the already cleared predicate devices selected to draw a comparison. ## 5-10. Conclusion: Following the examination of all the above mentioned information, we believe that the ARROW® Reverse Shoulder long keel and short keel glenoid base are substantially equivalent to the selected predicate devices in terms of intended use, ranges of sizes, materials, performances, safety and effectiveness.