Glenoid Polyaxial Non-locking Screws

{0}------------------------------------------------ Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118 Re: K181826 Trade/Device Name: Glenoid Polyaxial Non-locking Screws Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD, MBF Dated: November 14, 2018 Received: November 16, 2018 Dear Chris Lussier: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # 2.0 510(k) Summary #### I. Submitter Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66 Contact Person: Stefano Bai, Regulatory Affairs Manager, Medacta International SA Date Prepared: July 6, 2018 #### II. Device | Device Proprietary Name: | Glenoid Polyaxial Non-locking Screw | |--------------------------|-------------------------------------------------------------------| | Common or Usual Name: | Screw for Shoulder Prosthesis | | Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis | | Primary Product Code: | PHX, KWS, HSD and MBF | | Regulation Number: | 21 CFR 888.3660, 21 CFR 888.3690, and 21 CFR 888.3670 | | Device Classification | II | #### III. Predicate Device Substantial equivalence is claimed to the following devices: - . Glenoid Polyaxial Locking Screw (Medacta Shoulder Reverse System), K170452, Medacta International SA: - Delta Xtend™ Reverse Shoulder System, K062250 and K071379, DePuy Orthopaedics, Inc; ● - SMR 1M Modular Shoulder Replacement System, K100858, Lima; and - AEQUALISTM REVERSED II Shoulder Prosthesis, K112144, Wright Medical - Tornier. #### IV. Device Description The Glenoid Polyaxial Non-locking Screws are line extensions to the Medacta Shoulder Reverse System (K170452) and the Threaded Glenoid Baseplate (K171058); and provide compatibility with Short Humeral Stem (K180089). The Glenoid Polyaxial Non-locking Screws implants subject of this submission are comprised of the following products: {3}------------------------------------------------ Glenoid Polyaxial non-locking screw, 10 sizes: from L14 mm to L50 mm with 4mm increment. ● The Glenoid Polyaxial Non-locking Screws implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components: - Humeral Diaphysis Cemented: ● - Humeral Diaphysis Cementless; ● - Humeral Reverse Metaphysis; - Humeral Reverse HC Liner (also referred to as PE Liner); ● - Glenoid Baseplate - Pegged; - . Glenoid Baseplate - Threaded: - Glenoidsphere: ● - Glenoid Polyaxial Locking Screw (predicate item); - Glenoid Polyaxial Non-Locking Screw (subject item); ● - Reverse Metaphysis Screw; and ● - Glenoidsphere Screw. ● The Glenoid Baseplate (pegged version and threaded version) is intended to be fixed on the glenoid bone by means of a central pressfit and with the help of Glenoid Polyaxial Screws. The purpose of this submission is to gain clearance for the new Medacta Glenoid Polyaxial Non-Locking Screws, thus providing to surgeons an alternative to Glenoid Polyaxial Locking Screws for the Glenoid Baseplate fixation process. The Glenoid Polyaxial Non-Locking Screws are made of Ti-6Al-4V), enhanced with Type-II anodization, according to ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy. The Glenoid Polyaxial Non-Locking Screws are similar to the predicate devices Medacta Glenoid Polyaxial Locking Screw (K170452), DePuy Delta Xtend™ Reverse Shoulder System (K062250 and K071379), Lima SMRTM Modular Shoulder Replacement System (K100858) and Tornier AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144). #### V. Indications for Use The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthroplasty or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. {4}------------------------------------------------ #### VI. Comparison of Technological Characteristics The Glenoid Polyaxial Non-Locking Screws and the predicate devices share the following characteristics: - indications for use; - head design (with exception of Medacta Locking Screw predicate, K170452); ● - thread design; - ROM: - material of construction; - biocompatibility: - device usage: - sterility; - shelf life; and - packaging. ● The Glenoid Polyaxial Non-Locking Screws are technologically different from the predicate devices as follows: - . sizes and lengths. The subject Glenoid Polyaxial Non-Locking Screws have technological characteristics of the Medacta predicate device Glenoid Polyaxial Locking Screws (K170452) with the only exception of the Non-Locking mechanism, feature shared with the other predicates: the Non-Locking screws possess a cylindrical shaped head which allows for the insertion and placement of the implant into the dedicated seat of the baseplate, compressing it on the glenoid vault; on the other hand, the Locking screws own a "petal shaped" head which can also expand in order to lock its position into the baseplate. The subject Glenoid Polyaxial Non-Locking Screws provide a wider range of lengths if compared to predicate devices and these length options do not represent worst cases because the length of the screws does not have any influence on the mechanical properties (torque resistance and pull-out strength). Biocompatibility testing conducted on the predicate devices for the same or similar materials supports the biological safety of the Glenoid Polyaxial Non-Locking Screws. Subject and predicate devices are manufactured from the following material: Titanium Alloy (Ti-6Al-4V) ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy. This material has an extensive amount of biocompatibility data that has been provided in the listed predicate devices 510(k) submissions Medacta Glenoid Polyaxial Locking Screw (K170452), DePuy Delta Xtend™ (K062250 and K071379), Lima SMR™ Modular Shoulder Replacement System (K100858) and Wright Medical - Tornier AEQUALISTM REVERSED II Shoulder Prosthesis (K112144). {5}------------------------------------------------ #### VII. Performance Data Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in support of a substantial equivalence determination: Non-Clinical Studies: - Characterization Tests - o Design Validation Report. - Performance Tests ● - Micromotions Assessment In Reverse Configuration: ASTM F2028-14: Standards o Test Methods For Dynamic Evaluation of Glenoid Loosening Or Disassociation Prostheses: - Static Fatigue Testing: ASTM F543-13: Standard Specification And Test Methods o For Metallic Medical Bone Screws; and - Pull-Out Test: ASTM F543-17: Standard Specification and Test Methods for Metallic o Medical Bone Screws. - Pyrogenicity - Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and pyrogen test according to USP chapter <151> for pyrogenicity determination; and - O the subject devices are not labeled as non-pyrogenic or pyrogen free. Clinical Studies: - No clinical studies were conducted. ● # VIII. Conclusion Based on the above information, the Glenoid Polyaxial Non-Locking Screws are substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The Glenoid Polyaxial Non-Locking Screws implants are as safe and effective as the predicate devices Medacta Glenoid Polyaxial Locking Screw (K170452), DePuy Delta Xtend™ (K062250 and K071379), Lima SMRTM Modular Shoulder Replacement System (K100858), and Wright Medical - Tornier AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144). {6}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K181826 Device Name Glenoid Polyaxial Non-Locking Screws ### Indications for Use (Describe) The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthroplasty or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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. 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