Catalyst CSR 3 Peg Glenoids

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Catalyst OrthoScience, Inc Dale Davison Sr. VP of Manufacturing & Product Development 14710 Tamiami Trail North, Suite 102 Naples, Florida 34110 March 9, 2018 ### Re: K173812 Trade/Device Name: Catalyst CSR 3 Peg Glenoids Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT Dated: December 12, 2017 Received: December 15, 2017 Dear Mr. Davison: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-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, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### 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) K173812 Device Name Catalyst OrthoScience CSR Shoulder System Indications for Use (Describe) The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable. - Osteoarthritis - Avascular Necrosis ● - Rheumatoid Arthritis - Post-traumatic Arthritis - Correction of functional deformity Both components of the Catalyst CSR Shoulder System are intended for cemented use only. 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) {3}------------------------------------------------ | 510(k) Summary | | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared: | December 12, 2017 | | Submitter: | Catalyst OrthoScience, Inc.<br>14710 Tamiami Trail North, Suite 102<br>Naples, FL 34110 | | Contact: | Dale Davison<br>Sr. VP of Manufacturing & Product Development<br>Catalyst OrthoScience, Inc.<br>1-239-325-9976 ext 102<br>ddavison@catalystortho.com | | Proprietary Name: | Catalyst CSR 3 Peg Glenoids | | Common Name: | Shoulder Prosthesis | | Classification Names: | 21 CFR 888.3650: Shoulder joint metal/polymer non-<br>constrained cemented prosthesis; Class II | | Product Code: | KWT | | Substantially Equivalent<br>Devices | • Catalyst OrthoScience CSR Shoulder System, K152825<br>• DePuy Anchor Peg Glenoid, K981487<br>• Tornier Aequalis PerFORM+ Shoulder System, K150583 | #### Device Description: The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. This submission adds 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to {4}------------------------------------------------ provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees. #### Intended Use / Indications: The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable. - Osteoarthritis - Avascular Necrosis ● - Rheumatoid Arthritis ● - Post-traumatic Arthritis ● - Correction of functional deformity Both components of the Catalyst CSR Shoulder System are intended for cemented use only. #### Summary of Technologies/Substantial Equivalence: The Catalyst CSR 3 Peg Glenoids are substantially equivalent to the predicate devices in regards to intended use and indications, material, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues. #### Non-Clinical Testing: Static lever-out, static torque-out, dynamic shear testing of glenoid stability per ASTM F2028-14 were conducted on the Catalyst CSR 3 Peg Glenoid components. The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use. Bacterial Endotoxin Testing was performed on the predicate Catalyst CSR Glenoid components and the endotoxin limit of 20EU/device was met. The Catalyst CSR 3 Peg Glenoids did not create a new worst case for endotoxin levels. #### Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices.