Equinoxe® Central Screw Baseplate System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Exactech Inc. Liz Howell Senior Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653 Re: K233482 Trade/Device Name: Equinoxe® Central Screw Baseplate System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT Dated: June 18, 2024 Received: June 18, 2024 Dear Liz Howell: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). July 18, 2024 {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Farzana Sharmin Digitally signed by Farzana -S Sharmin -S Date: 2024.07.18 10:05:59 -04'00' Farzana Sharmin, PhD 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 {2}------------------------------------------------ **Indications for Use** #### 510(k) Number (if known) K233482 Device Name Equinoxe® Central Screw Baseplate System Indications for Use (Describe) The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment. - The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation. - The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon. - . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon. - . Humeral Heads are intended for use in cemented and press-fit applications. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: | P | L | F | Indications | |---|---|---|------------------------------------------------------------------------------------------------------------------------| | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | | √ | √ | | Congenital abnormalities in the skeletally mature | | √ | | | Primary and secondary necrosis of the humeral head. | | √ | | √ | Humeral head fracture with displacement of the tuberosities | | √ | √ | | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | | √ | √ | | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | | | | √ | Displaced three-part and four-part upper humeral fractures | | | √ | | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | | √ | √ | | Revision of failed previous reconstructions when distal anchorage is required | | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) | The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) O Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ #### 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, includingthe time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collections for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not respond to, a collection of informationunless it displays a currently valid OMB number." {4}------------------------------------------------ # Equinoxe® Central Screw Baseplate System Traditional 510(k) - 510(k) Summarv | Applicant: | Exactech®, Inc<br>2320 N.W. 66th Court<br>Gainesville, FL 32653<br>Phone: (352) 377-1140 | |----------------------|------------------------------------------------------------------------------------------| | Applicant Contact: | Liz Howell<br>Principal Regulatory Specialist | | Device Trade Name: | Equinoxe® Central Screw Baseplate System | | Common Name: | Shoulder Prosthesis, Reverse Configuration | | Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis | | Regulation Number | 21 CFR 888.3660 | | Product Code: | PHX, KWT | ## Legally Marketed Predicate Devices | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | K063569 | Equinoxe Reverse Shoulder System | PHX, KWT | | K182536 | Exactech® Equinoxe® Small Reverse Shoulder Glenospheres, Exactech<br>Equinoxe Reverse Shoulder Humeral Liners, Exactech Equinoxe Small<br>Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder<br>Locking Cap | PHX, KWT,<br>KWS | | K080642 | Comprehensive Reverse Shoulder | PHX, KWS | ## Device Description Summary The Central Screw Baseplate System is comprised of devices that will be included as part of the Exactech Equinoxe® Shoulder System for reverse total shoulder arthroplasty (rTSA). The Central Screw Baseplate System includes Glenoid Baseplates, Central Compression Screws, a Locking Plate, a Locking Nut, and a Glenosphere Locking Screw. Previously cleared components used with the Central Screw Baseplate System include Peripheral Screws and Glenoid components. The design of the proposed Central Screw Baseplate System is based on the existing foundation and principles of the currently marketed Equinoxe Standard and Small Reverse Baseplates. #### Intended Use/Indications for Use The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. - The cemented primary humeral stem, long/revision stems and all Equinoxe glenoids are intended for cemented fixation. - The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon. - The reverse humeral components are intended to be used in cemented applications or in revision ● cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon. {5}------------------------------------------------ - Humeral Heads are intended for use in cemented and press-fit applications. ● Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: | P | L | F | Indications | |---|---|---|---------------------------------------------------------------------------------------------------------------------------| | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | | √ | √ | | Congenital abnormalities in the skeletally mature | | √ | | | Primary and secondary necrosis of the humeral head. | | √ | | √ | Humeral head fracture with displacement of the tuberosities | | √ | √ | | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | | √ | √ | | Revisions of humeral prostheses when other treatments or devices have failed (where adequate<br>fixation can be achieved) | | | | √ | Displaced three-part and four-part upper humeral fractures | | | √ | | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative<br>diseases) | | | √ | | Revision of failed previous reconstructions when distal anchorage is required | | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) | The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only. ## Indications for Use Comparison The subject and the predicate devices have the same indications for use. ## Technological Comparison The proposed and predicate devices have intended use and basic fundamental scientific technology. The rationale for substantial equivalence of the proposed to the predicate cleared devices is based on consideration of the following aspects of the devices: - The proposed and predicate devices are composed of the same or similar biocompatible materials. ● - . The proposed and predicate devices have the same or similar design features. - The proposed and predicate devices are provided sterile for single use only. {6}------------------------------------------------ - . The proposed and predicate devices conform to recognized performance standards for shoulder replacement devices. ### Non-Clinical and/or Clinical Tests Summary & Conclusions The following non-clinical testing and engineering analyses were performed to demonstrate that the Equinoxe® Central Screw Baseplate System performs as intended and is substantially equivalent to the identified predicate devices: - Range of motion per ASTM F1378-18e1 . - . Screw testing per ASTM F543-23 - . Fretting and fretting assisted corrosion testing - Fixation testing per ASTM F2028-17 - Glenosphere-Baseplate disassembly testing - . Biocompatibility per ISO 10993-1:2018 - . Bacterial endotoxins per USP <161>, USP <85> and ANSI/AAMI ST72 The differences in material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including range of motion. fretting and fretting assisted corrosion, Central Screw strength, fixation, glenosphere-baseplate disassembly, and biocompatibility assessment completed to establish substantial equivalence of the proposed devices to the predicate device.