Lateralized Glenosphere

{0}------------------------------------------------ August 11, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Medacta Inernational SA Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118 ### Re: K193175 Trade/Device Name: Lateralized Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, MBF Dated: July 10, 2020 Received: July 13, 2020 ### 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. 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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 {1}------------------------------------------------ device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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). 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Sincerely, For Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193175 Device Name Lateralized Glenosphere ### 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 deficient rotator cuff shoulder joint with severe arthropathy 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. 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Device | Device Proprietary Name: | Lateralized Glenosphere | |--------------------------|-------------------------------------------------------------------| | Common or Usual Name: | Shoulder Prosthesis, Reverse Configuration | | Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis | | Primary Product Code: | PHX | | Secondary Product Code: | HSD and MBF | | Regulation Number: | 21 CFR 888.3660 (Primary), 21 CFR 888.3690 and 21 CFR 888.367 | | Device Classification | II | #### III. Predicate Device Substantial equivalence is claimed to the following devices: - > Primary Predicate: - · Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International SA; - > Reference Device: - · Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tornier, Inc. #### Device Description IV. The Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse System (K170452) and are compatible with the other Medacta cleared products Threaded Glenoid Baseplate (K171058), Glenoid Polyaxial Non-Locking Screws (K181826) and the Short Humeral Stem (K180089). {4}------------------------------------------------ The Lateralized Glenosphere implants subject of this submission are comprised of the following products (9 sizes): - Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm ● - . Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm - Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm ● - . Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm The Lateralized Glenosphere 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; ● - Glenosphere; ● - . Glenoid Polyaxial Locking Screw; - . Glenoid Polyaxial Non-Locking Screw; - Reverse Metaphysis Screw; and ● - Glenosphere Screw. ● The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw. The purpose of the current submission is to gain clearance for the Lateralized Glenospheres, whose center is more lateralized respect to Medacta predicate device Glenosphere (Medacta Shoulder Reverse System - K170452). The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy. The Lateralized Glenosphere is made of CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6A1-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery -Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy. The Lateralized Glenosphere implants are substantially equivalent to Medacta predicate device Glenosphere implants (K170452) and to competitor predicate device Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tornier, Inc. {5}------------------------------------------------ #### 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 deficient rotator cuff shoulder joint with severe arthropathy 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. #### VI. Comparison of Technological Characteristics The Lateralized Glenosphere and the main predicate device (cleared within Medacta Shoulder Reverse System) K170452, Medacta International SA share the following characteristics: - indications for use; ● - material of construction: - sizes - eccentricity of the COR (Center Of Rotation); - biocompatibility; - device usage: - sterility; - shelf life; and - packaging. The Lateralized Glenosphere is technologically different from the main predicate device as follows: - lateralization of the COR. The subject Lateralized Glenosphere has the same technological characteristics of the Medacta predicate device Glenosphere (cleared within Medacta Shoulder Reverse System) K170452, with the only exception of the grade of lateralization of the COR, feature shared with the other predicate AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144). This new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy. Biocompatibility testing conducted on the main predicate device for the same materials supports the biological safety of the Lateralized Glenosphere. Subject and predicate devices are manufactured from the following material: CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery – Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6Al-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy. {6}------------------------------------------------ #### 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 substantial equivalence determination: Non-Clinical Studies: - Characterization Tests . - o Design Validation Report. - Performance Tests - Assessment In Reverse Configuration With A Lateralized o Micromotions Glenosphere: ASTM F2028-17: Standards Test Methods For Dynamic Evaluation of Glenoid Loosening or Disassociation; - Fatigue Test On Threaded Glenoid Reverse Construct With A Lateralized о Glenosphere: ASTM F1378-17 - Standard Specifications for Shoulder Prosthesis; and - Rationale, Lateralized Glenosphere Wear Assessment. o - 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 - the subject devices are not labeled as non-pyrogenic or pyrogen free. O Clinical Studies: - No clinical studies were conducted. ● ## VIII. Conclusion Based on the above information, the Lateralized Glenospheres 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 Lateralized Glenosphere implants are as safe and effective as the predicate devices Medacta standard Glenosphere cleared under Medacta Shoulder Reverse System K170452 (predicate device) and Tornier AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144).