Arthrex Eclipse Shoulder Prosthesis System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. July 26, 2019 Arthrex Inc. David Rogers Regional Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K183194 Trade/Device Name: Arthrex Eclipse Shoulder Prosthesis System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHQ, PKC Dated: June 25, 2019 Received: June 26, 2019 Dear David Rogers: 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). 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Sincerely, FOR CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K183194 Device Name Arthrex Eclipse Shoulder Prosthesis System #### Indications for Use (Describe) The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement. Type of Use (Select one or both, as applicable): | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions 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 required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Date Prepared July 26, 2019 ### Submitter Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 ### Contact Person David L Rogers Manager, Regulatory Affairs 1-239-643-5553, ext. 71924 david.rogers@arthrex.com ### Name of Device Arthrex Eclipse Shoulder Prosthesis System Common Name Shoulder Prosthesis Product Code PKC, QHQ Classification Name 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis ### Regulatory Class ll Primary Predicate Device K071032: Arthrex Univers II Shoulder Prosthesis K171858: Sidus Stem-Free Shoulder K143552: Simpliciti Shoulder System Reference Predicate Device K173388: Exactech Equinox # Purpose of Submission This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Eclipse Shoulder Prosthesis. ### Device Description The Arthrex Eclipse Shoulder Prosthesis is a stemless humeral joint (hemi-shoulder) prosthesis that is designed as a humeral head replacement device. It consists of a humeral head; a trunnion; and a hollow screw. The Arthrex Eclipse Shoulder Prosthesis System replaces the proximal humeral bone, including surface, using an {4}------------------------------------------------ anatomical reconstruction surgical technique. The Eclipse fixates to the humeral bone by a hollow screw that is torqued into place. The humeral head is manufactured from Cobalt Chromium (CoCr) and is offered in 10 sizes (39-55mm) with varying offsets of 16-23mm. The trunnion is manufactured from Titanium alloy (Ti6Al4V) with a titanium plasma spray (TPS) Calcium Phosphate (CaP) coating and is available in 10 sizes (37-55mm). The hollow screw is manufactured from Titanium alloy (Ti6Al4V) and is offered in 4 sizes (30-45mm). ### Indications For Use The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement. ### Summary of Technological Characteristics The Arthrex Eclipse Shoulder Prosthesis System has the same intended use as the primary predicate devices. The technological characteristics (material, sizing, indications, coating, shelf-life, and sterilization) of the Arthrex Eclipse Shoulder Prosthesis System are substantially equivalent to the predicate devices. The design differences have been demonstrated through clinical and non-clinical performance data and do not raise new issues of safety or effectiveness. The primary difference between the Arthrex Eclipse Shoulder Prosthesis System and the predicate Arthrex Univers II is that the Eclipse is a stemless as opposed to a stem design. However, the Arthrex Eclipse is similar to other legally marketed stemless shoulder devices, such as the Sidus Stem-Free Shoulder and the Simpliciti Shoulder System. The primary difference between the Arthrex Eclipse and the stemless predicate devices is the fixation of the humeral component. The Arthrex Eclipse achieves humeral fixation by torqueing the humeral hollow screw component into the humeral bone whereas the stemless predicate devices are fixate by press-fit designs. The table below summarizes the technological characteristics of the Arthrex Eclipse and the predicate devices. | | Arthrex Eclipse<br>(This Submission) | Arthrex Univers II<br>(K071032) | Sidus Stem-Free<br>Shoulder (K171858) | Simpliciti Shoulder<br>System (K143552) | |------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|-----------------------------------------| | Material | Cobalt Chromium<br>Titanium | Cobalt Chromium<br>Titanium | similar | similar | | Head Size range | 39-55mm | 40-56mm | similar | similar | | Humeral<br>component size<br>range | 30-45mm | 115-151mm | similar | similar | | Fixation Method | Screw/Torque | Press Fit | Press Fit | Press Fit | | Sterility | Gamma Irradiation | similar | similar | similar | | Single Use | Yes | Yes | Yes | Yes | | Intended Use | Total Arthroplasty of<br>the Shoulder | Total Arthroplasty of<br>the Shoulder | Total Arthroplasty of<br>the Shoulder | Total Arthroplasty of<br>the Shoulder | # Nonclinical Performance Data Static and dynamic compression testing was performed to evaluate the fatigue resilience of the proposed Arthrex Eclipse Shoulder Prosthesis. The testing demonstrates that the fatigue strength of the proposed devices meets the same acceptance criteria as the predicate device for the desired indications. {5}------------------------------------------------ A review of clinical literature on the Arthrex Eclipse, which reports on clinical effectiveness outcomes (i.e., Constant Score, Oxford Shoulder Score, range of motion), radiographic findings, and clinical safety outcomes. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. ### Clinical Performance Data #### Level of Evidence & Location of Study A pivotal study was held in the United States as a prospective, randomized, multi-center study to evaluate the safety and effectiveness of the Arthrex Eclipse Shoulder Prosthesis compared to the Univers II Shoulder Prosthesis (conventional stemmed shoulder) for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. #### Primary Composite Endpoint To be considered a success, the Eclipse subject must meet the following composite clinical success criteria: - An improvement in the Adjusted Constant Score (for pain, function, and range of motion) from baseline ● (pre-op) to the Month 24 time-point that is ≥10 points and a final Adjusted Constant Score ≥54. - . Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time point), glenoid migration/subsidence (relative to 3 month time point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. - No reoperation, removal, or modification of any study component up to the subject's completion of the study. - . No serious device-related complications up to the subject's completion of the study. For the composite clinical success measurement using subjects with complete data at Month 24, the success rate was 92.3% for the Eclipse group compared with 89.7% for the Univers II group. The difference between Eclipse and Univers II was 2.6%. The lower-bound of the 1-sided 95% confidence interval for the group difference was -4.5%. The data presented in the table below demonstrate the non-inferiority of the Eclipse subjects to the Univers II control subjects in the overall primary endpoint. | | Eclipse | | | Univers II | | | Dif | 95% | 98.131% | |-----|-----------------|-------------|--------------|-----------------|-------------|--------------|-------|------------|------------| | | Population Size | Sample Size | Success Rate | Population Size | Sample Size | Success Rate | % | 1-sided LB | 1-sided LB | | 143 | 132 | 92.3% | 68 | 61 | 89.7% | 2.6% | -4.5% | -6.4% | | Using the O'Brien-Fleming method to correct for interim analyses, the lower-bound of the 1-sided 98.131% confidence interval for the group difference was -6.4%. Since both -4.5% and -6.4% are greater than -10%, the results from this comparison demonstrate that the study success criteriority has been achieved, even when utilizing a strict success criterion adjusting for interim analyses. #### Primary Effectiveness Endpoint Adjusted Constant Score: 97.1% of Eclipse subjects experienced a clinically meaningful improvement from baseline (defined as a ≥10 point increase and score value ≥54) at Month 24 compared to 92.5% of Univers II subjects. Secondary effectiveness endpoints measuring pain, function, and overall quality of life demonstrate that a large percentage of Eclipse subjects achieve a clinically significant improvement at 3 months that persists to 24 months following surgery, in similar rates as the Univers II subjects. #### Safety A Kaplan-Meier approach was utilized for subjects who were considered SSI failures per the primary endpoint (n=7 Eclipse and n=2 Univers II). The rate of subsequent surgical intervention was 3.6% for Edipse subjects and 3.1% for the control subjects through 24 months. In the Eclipse group, two subjects required surgery due to confirmed or {6}------------------------------------------------ suspected infection; three subjects required revision due to torn rotator cuff or subscapularis tendon; and two subjects required revision due to injury to the shoulder sustained from a fall. In the Univers II group, two subjects required revision due to torn rotator cuff or subscapularis tendon; and one had a reoperation adjacent to the joint (distal clavicle resection) due to pain. The rate of events that were considered device-related was similar between the two groups (Eclipse: 1.4% vs Univers II: 1.3%). The rate of events that were considered procedure-related was also similar between the two groups (Eclipse: 23.2% vs Univers II: 20.5%). The Eclipse patients did not experience any radiographic failures and had a higher adjusted Constant Score in comparison to the control. #### Significant Findings Glenoid lucencies were reviewed for Eclipse and Univers II subjects in this study with particular attention to the radiolucency grades observed. At Month 24, the majority of subjects had no glenoid radiolucencies (Grade 0) or minor radiolucencies (Grades 1, 2). A very small percentage of subjects had glenoid radiolucencies ≤2 mm wide (Grade 3) around two or more pegs or around the keel, as applicable. No subjects had glenoid radiolucencies >2 mm wide (Grade 4) or gross loosening (Grade 5). For the subjects with Grade 3 glenoid radiolucencies, the difference in proportions between the control and investigational groups was not significant for either fixation type. Rotator Cuff tears were observed in both Eclipse and Univers II groups. However, the rates were low (2.3% Eclipse and 1.4% Univers II). Rotator cuff deficiencies are not typically device related and there are no differences in surgical exposure with the Eclipse compared to stemmed arthroplasties or other stems. #### Summary Based on the clinical performance as documented in the pivotal clinical study, the Arthrex Eclipse Shoulder Prosthesis System was found to have a safety and effectiveness profile that is similar to the predicate device. ### Literature Review A total of 298 unique publications were screened and reviewed during the time frame searched (01 January 2008 to 22 May 2019). From this list, abstracts were reviewed and publications excluded if they were not publications focused on clinical experience of the subject device. When needed, the full text was obtained for more in-depth evaluation for possible contribution in providing supportive data for the effectiveness and/or the safety of the subject device used as intended, whether it contained favorable or unfavorable findings. In total, nine studies were included, reporting on 748 shoulders treated with the ECLIPSE Shoulder Prosthesis. The reviewed literature shows the device is effective and safe when used as intended. The authors collected relevant information related to the effectiveness and safety of the device. Five studies reported the same pain score measure of the Constant Score and consistently demonstrated a successful reduction in pain and return to activities of daily living. One additional article patient reported outcome measure and found the device to be effective in improvement of patient function. All authors who reported effectiveness data reached favorable conclusions for the use of the ECLIPSE device. While radiographic findings were commonly reported, the majority did not correlate with clinical results (e.g., decline in function or reported adverse event), and a large number were associated with the glenoid component. Heuberer, et al. (2018 mixed cohort) reported radiological changes in 37.0% of patients, i.e., partial osteolysis in approximately 6.9% of patients and complete osteolysis in one or more zones in approximately 30.1% of patients. While there were a large number of radiographic changes noted by the radiologist, these findings did not represent an increased chance of revision surgery or in the patient's clinical outcome (e.g., Constant Score). Additionally, at mid-term follow-up, 96.2% of patients were very satisfied with their ECLIPSE. Hawi, et al. (2017 mixed cohort) reported incomplete radiolucency < 1mm in 2.3% of shoulders on the humeral side and an {7}------------------------------------------------ incomplete radiolucent line was observed in 27.3% of shoulders on the glenoid side. There were no instances of loosening on the humeral or glenoid side and only 1 instance of secondary glenoid wear on the glenoid side. It is important to note that these findings are through 9 years of follow-up, and the authors hypothesize the changes may be due to age-related osteopenia. Authors consistently reported findings were comparable to other literature studies, and possibly attributable to age-related comorbidities. It should also be noted that there is a limitation with radiographic findings reported across literature studies due to the varying definitions used to define radiographic changes, as well as the quality and consistency of the images used. All clinical complications were consistent with those anticipated for a shoulder arthroplasty patient population. Higher rates were reported for loosening (10.0%), infection (9.8%), rotator cuff deficiency / tear (12%), and secondary glenoid erosion (11.0%). The 10% loosening was reported in two out of 20 patients and specific to the glenoid component. Rotator cuff deficiency / tear was reported at a rate of 12% in two studies treating patients with hemi or total shoulder arthroplasty. Heuberer, et al. (2018 mixed cohort) reported nine instances (12.3%) of secondary rotator cuff repair post-operatively requiring revision and Hawi, et al. (2017 mixed cohort) reported six instance of rotator cuff deficiency, but only two events required secondary intervention. Follow-up in these studies ranged from nearly 5 years to over 9 years post-op. Both authors concluded the rates align with literature for total shoulder arthroplasty, where secondary cuff failure is the primary reason for revision. Secondary glenoid erosion, specific to the glenoid component, was reported in eight patents in a single study. Johansson, et al. (2018) reported a higher rate of infection in the ECLIPSE group (9.8%); however, the authors noted limitations in the study and potential bias in the patient population. These events are anticipated with shoulder surgery, and were considered by the authors to be comparable to or better than controls or similar studies for stemmed shoulder devices. # Conclusion The Arthrex Eclipse Shoulder Prosthesis has the same intended use and the same fundamental scientific technology as the Arthrex Univers II Shoulder Prosthesis System, Sidus Stem-Free Shoulder, and Simpliciti Shoulder System. Based on the clinical data, non-clinical data, and literature review presented in this 510(k) for the subject and predicate devices, Arthrex concludes that the proposed device is substantially equivalent to the currently marketed predicate devices.