Aequalis Flex Revive Shoulder System

{0}------------------------------------------------ September 20, 2018 Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Tornier, Inc. Laurie Lewandowski Regulatory Associate, Consultant 10801 Nesbitt Ave South Bloomington, Minnesota 55437 Re: K181420 Trade/Device Name: Aequalis Flex Revive Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PHX, HSD Dated: August 30, 2018 Received: August 31, 2018 Dear Laurie Lewandowski: 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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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 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, | Vesa | Digitally signed by Vesa Vuniqi -S | |-----------|------------------------------------| | Vuniqi -S | Date: 2018.09.20 | | | 16:24:14 -04'00' | Mark N. Melkerson For: Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K181420 Device Name Aequalis Flex Revive Shoulder System Indications for Use (Describe) IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AEQUALIS FLEX REVIVE Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of other devices if sufficient bone stock remains #### IN REVERSE: The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: - Rheumatoid arthritis - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Massive and non-repairable rotator cuff tear - · Revision of the devices if sufficient bone stock remains The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. #### Notes: - All components are single use. - · The coated humeral stem is intended for cemented or cementless use. - · The all-poly glenoid components are intended for cemented use only - · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. · Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) > 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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Date Prepared: May 30, 2018 #### Administrative Information | Name: | Tornier, Inc. | |-----------------|---------------------------------------------------------------------------------| | Address: | 10801 Nesbitt Avenue South<br>Bloomington, MN 55437<br>United States of America | | Contact Person: | Laurie Lewandowski | | Title: | Regulatory Associate, Contract | | Phone: | 612-770-4038 | | Fax: | 952-426-7601 | ## Device Information Name of Device: AEQUALIS FLEX REVIVE Shoulder System Common Name (s): Classification Name: Prosthesis, Shoulder, Semi-Constrained, Metal/ Polymer Cemented Regulatory Class: II Regulation Number: 888.3660, 888.3690 Product Code: KWS, PHX, HSD ## Predicate Device Information | Predicate Device: | Aequalis Ascend Flex Shoulder System | |-------------------|----------------------------------------------| | 510K number: | K140082 | | Reference Device: | Aequalis Adjustable Reversed Shoulder System | | 510K Number: | K141029 | ## Device Description AEQUALIS FLEX REVIVE Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), spacer(s), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts. The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Ascend Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery. Tornier AEQUALIS FLEX REVIVE Shoulder System {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon with a stylized letter "T" inside. The letter "T" is also blue and has a smaller hexagon inside of it. The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 180 mm (using the standard proximal body, spacers, and stem) in 10mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity. The proximal body, stem, and spacers are made from Ti6Al4V per ASTM F-136. The proximal body and stem have a Titanium plasma coating. The assembly screw and locking cap are made from of CoCr per ISO 5832-121. They are single use and packaged sterile, using gamma radiation at a minimum dose of 25 KGy to an SAL of 1x10-6. The AFR Shoulder System is comprised of the component in Table 5.1. | Catalog # | Description | Diameter (mm) | Effective Length (mm) | Angle (°) | |---------------|---------------------|----------------------------|-----------------------|-----------| | Proximal Body | | | | | | ARS741701 | Proximal Body | Ø9 | 40 | 132.5 | | ARS741702 | Proximal Body | Ø11 | 40 | 132.5 | | ARS741703 | Proximal Body | Ø13 | 40 | 132.5 | | ARS741704 | Proximal Body | Ø15 | 40 | 132.5 | | ARS741705 | Proximal Body | Ø17 | 40 | 132.5 | | ARS741706 | Proximal Body | Ø19 | 40 | 132.5 | | ARS741707 | Short Proximal Body | Ø9 | 30 | 132.5 | | ARS741708 | Short Proximal Body | Ø11 | 30 | 132.5 | | ARS741709 | Short Proximal Body | Ø13 | 30 | 132.5 | | ARS741710 | Short Proximal Body | Ø15 | 30 | 132.5 | | ARS741711 | Short Proximal Body | Ø17 | 30 | 132.5 | | ARS741712 | Short Proximal Body | Ø19 | 30 | 132.5 | | Spacers | | | | | | Catalog # | Description | Size (diam. and length mm) | | | | ARS342001 | Spacer | Ø9 x 20 | | | | ARS342002 | Spacer | Ø11 x 20 | | | | ARS342003 | Spacer | Ø13 x 20 | | | | ARS342004 | Spacer | Ø15 x 20 | | | | ARS342005 | Spacer | Ø17 x 20 | | | | ARS342006 | Spacer | Ø19 x 20 | | | | ARS342007 | Spacer | Ø9 x 30 | | | | ARS342008 | Spacer | Ø11 x 30 | | | | ARS342009 | Spacer | Ø13 x 30 | | | | ARS342010 | Spacer | Ø15 x 30 | | | | ARS342011 | Spacer | Ø17 x 30 | | | | ARS342012 | Spacer | Ø19 x 30 | | | ## Table 5. 1 AFR Shoulder System Components Tornier AEQUALIS FLEX REVIVE Shoulder System {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon shape, also in blue. Inside the hexagon is a stylized letter "T", with a smaller hexagon shape inside the "T". | Distal Stem | | | | |----------------|-----------------------|-----------------------|-------------| | Catalog # | Description | Diameter (mm) | Length (mm) | | ARS741801 | Distal Stem | Ø9 | 90 | | ARS741802 | Distal Stem | Ø11 | 90 | | ARS741803 | Distal Stem | Ø13 | 90 | | ARS741804 | Distal Stem | Ø15 | 90 | | ARS741805 | Distal Stem | Ø17 | 90 | | ARS741806 | Distal Stem | Ø19 | 90 | | Assembly Screw | | | | | Catalog # | Description | Effective Length (mm) | | | ARS655101 | Assembly Screw | 0 | | | ARS655102 | Assembly Screw | 20 | | | ARS655103 | Assembly Screw | 30 | | | ARS655104 | Assembly Screw | 40 | | | ARS655105 | Assembly Screw | 50 | | | ARS655118 | Assembly Screw, Short | 0 | | | ARS655119 | Assembly Screw, Short | 20 | | | Locking Cap | | | | | Catalog # | Description | | | | ARS655200 | Locking Cap | | | ## Intended Use The AEQUALIS FLEX REVIVE Shoulder System is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status. # Indications for Use ## IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AEQUALIS FLEX REVIVE Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity Tornier AEQUALIS FLEX REVIVE Shoulder System {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon with a stylized letter "T" inside. The logo is also colored in blue and has a modern, geometric design. - Fractures of the humeral head - Traumatic arthritis - · Revision of other devices if sufficient bone stock remains # IN REVERSE: The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: - . Rheumatoid arthritis - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) . - Correction of functional deformity . - Fractures of the humeral head . - Traumatic arthritis . - Massive and non repairable rotator cuff tear . - . Revision of the devices if sufficient bone stock remains The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. ## Notes: - · All components are single use. - · The coated humeral stem is intended for cemented or cementless use. - · The all-poly glenoid components are intended for cemented use only - · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium allovs are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. # Comparison of Technological Characteristics with the Predicate Device Table 5.2 compares the technological characteristics of the AFR shoulder System to the predicate. Aequalis Ascend Flex and the reference device. Aequalis Adiustable Reversed as applicable. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Tornier. The word "TORNIER" is written in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized "T" shape. | | | Table 5. 2 Comparison of Technological Characteristics | | |--|--|--------------------------------------------------------|--| |--|--|--------------------------------------------------------|--| | | Aequalis Flex Revive<br>Shoulder System (AFR) | Predicate Ascend Flex (K140082)<br>Reference Device Adjustable Reversed<br>(K141029) | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design Principal | Modular design to allow the<br>surgeon to select the<br>components to size the shoulder<br>system for the patient;<br>convertible from anatomic to<br>reversed without removing the<br>implant assembly | Ascend Flex – multiple sizes for surgeon<br>selection; convertible from anatomic to<br>reversed without removing the implant<br>assembly.<br>Adjustable Reverse - modular design to<br>allow surgeon to select the components<br>to size the shoulder system for the<br>patient. | | Overall lengths | Adjustable total lengths from<br>120mm to 180mm (10mm<br>increments) | Ascend Flex -<br>66mm to 98mm (standard coated)<br>88mm to 130mm (long coated)<br>66mm to 94mm (standard non-coated)<br>88mm to 125mm (long non-coated)<br>Adjustable Reverse - adjustable length,<br>using spacers, up to 210mm | | Stem and Spacer<br>Diameters<br>(diaphysis) | 9, 11, 13, 15, 17, 19 mm | Ascend Flex-<br>Standard Stems: 9 – 20mm<br>Long Stems: 9 – 20mm<br>Adjustable Reverse - 9, 11, 13, 15, 17mm | | Spacer length | 20, 30 mm | Ascend Flex - N/A<br>Adjustable Reversed - 15, 20, 25, 50, and<br>100mm | | Materials | Proximal body, spacers, distal<br>stems: Titanium alloy<br>(Ti6Al4V) and commercially<br>pure Ti (coating)<br>Assembly Screw and Locking<br>Cap: CoCr | Titanium alloy (Ti6Al4V) and<br>commercially pure Ti (coating) | | Sterility Assurance<br>Level (SAL) | 1x10-6 | Identical | | Sterilization<br>Method | Gamma | Identical | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design, with a smaller hexagon shape incorporated into its structure. # Non-clinical Performance Testing Table 5.3 is a summary of the testing performed on the AEQUALIS FLEX REVIVE Shoulder System. | Table 5. 3 Summary of the Testing Performed on the AFR Shoulder System | | | |------------------------------------------------------------------------|--|--| | | | | | Test Performed | Acceptance Criteria | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fatigue Testing | The humeral stems were tested to 10 million cycles (5 million<br>in each configuration) without failure, fracture, or dislocation<br>when inspected after each tested configuration at a<br>magnification of 50X. | | Range of Motion | The Aequalis Flex Revive Shoulder System met the range of<br>motion requirements in ASTM F1378-12. | | Taper Tensile | Taper resultant force were not significantly lower than those of<br>the Ascend Flex taper connections when analyzed with a 2-<br>sample T-test. | | Tensile Static Torque | The disassociation torque of the male taper from the female<br>taper was not statistically lower than 1.72Nm, or two times the<br>anticipated frictional torque between glenoid sphere and the<br>reversed insert. | | Press Fit Preparation | The AFR Shoulder System achieved a press-fit for the proximal<br>body and distal stem allowing the implant to attain proper<br>seating and acceptable fixation. | | Cemented Preparation | The AFR Humeral Stem cement mantle thickness met or<br>exceeded the Ascend Flex cement mantle thickness. | | Biocompatibility | Biocompatibility requirements per ISO 10993-1 were met | | Endotoxin | Endotoxin results per ST72 demonstrated <20EU/device | | Packaging | Distribution testing met requirements per ASTM D4169-16 | # Conclusions The AEQUALIS FLEX REVIVE Shoulder System has similar intended use and indications for use as the predicate, Ascend Flex Shoulder System (K140082). The reference device supports the use of the spacers to allow the surgeon to select the implant construct length for the patient. Testing demonstrated the AFR met the test requirements and compares favorably to the predicate. The AFR Shoulder System is substantially equivalent to the Ascend Flex Shoulder System.