SIGMA High Performance (HP) Partial Knee System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". April 16, 2020 DePuy Ireland UC % Brad Osborne Regulatory Affairs Specialist II DePuv Synthes. Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582 Re: K193549 Trade/Device Name: SIGMA High Performance (HP) Partial Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: HRY, OIY Dated: February 17, 2020 Received: February 18, 2020 Dear Brad Osborne: 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 {1}------------------------------------------------ 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) 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 (OS) 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). 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, for Ting Song, Ph.D., R.A.C. 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) K193549 Device Name SIGMA High Performance (HP) Partial Knee System Indications for Use (Describe) ### INDICATIONS The SIGMA High Performance Partial Knee System is indicated for single compartment in sketally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral articular surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.375L5.75 10.875L2.75 7.875" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> </span> </div> | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> </span> </div> | ### 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 (As required by 21 CFR 807.92 and 21 CFR 807.93) | Submitter Information | | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy Ireland UC | | Address | Loughbeg, Ringaskiddy<br>Co. Cork Munster, Ireland | | Phone number | 574-371-4724 | | Fax number | 574-371-4987 | | Establishment Registration Number | 1818910 | | Name of contact person | Brad Osborne | | Date prepared | 4/16/2020 | | Name of device | | | Trade or proprietary name | SIGMA High Performance (HP) Partial Knee System | | Common or usual name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | | Classification name | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis | | Class | II | | Classification panel | 87 Orthopedics | | Regulation | Primary: 21 CFR 888.3530<br>Secondary: 21 CFR 888.3560 | | Product Code(s) | Primary: HRY<br>Secondary: OIY | | Legally marketed device(s) to which<br>equivalence is claimed | K070849 DEPUY GCK (SIGMA HP Partial) FEMORAL AND TIBIAL COMPONENTS<br>K070267 DEPUY GCK (SIGMA HP Partial) TIBIAL COMPONENTS<br>K061648 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (SIGMA HP Partial)<br>K101433 DEPUY ATTUNE KNEE SYSTEM | | Reason for 510(k) submission | This submission describes additional inserts compatible with the previously cleared SIGMA High<br>Performance (HP) Partial Knee System (previously referred to as DePuy Graduated Compartmental Knee or<br>GCK) and includes a labeling update to the existing IFU. | | Device description | The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis,<br>composed of individually packaged femoral and tibial components designed to be used in various<br>combinations to replace the natural articular surfaces of the knee joint.<br><br>The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a<br>porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available<br>without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from<br>polyethylene.<br><br>The unicompartmental femoral components are designed for individuals who require a higher than normal<br>degree of flexion (up to 155°). | | Intended use of the device | The DePuy SIGMA HP Partial Knee System is intended to provide increased patient mobility and reduced<br>pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound<br>bone to seat and support the components. | | Indications for use | <b>INDICATIONS</b><br>The SIGMA High Performance Partial Knee System is indicated for single compartmental knee<br>replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the<br>tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for<br>CEMENTED USE ONLY. | {4}------------------------------------------------ {5}------------------------------------------------ | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | | | | |---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Subject Device: | Predicate Device: | AOX Reference Device: | | | SIGMA HP Uni AOX Insert | SIGMA HP Partial Knee XLK Insert<br>(K061648, K070267, K070849) | DePuy ATTUNE Knee System AOX Insert<br>(K101433) | | Intended Use | Unicondylar Knee Arthroplasty | Unicondylar or Partial Knee Arthroplasty | Total Knee Arthroplasty | | Properties | | | | | Material | AOX UHMWPE | XLK UHMWPE | AOX UHMWPE | | Fixation | Cemented | Cemented | Cemented | | Sizes | Tibial Inserts: 6 Sizes, 7mm-11mm thickness in 1mm increments | Femoral & Tibial Components: 6 Sizes<br>Tibial Inserts: 6 Sizes, 7mm-11mm thickness in 1mm increments | CR Fixed Bearing Tibial Inserts<br>Sizes 1-10 with 5, 6, 7, 8, 10, 12,<br>14, 16mm options for each<br>PS Fixed Bearing Tibial Inserts<br>Sizes 1-10 with 5, 6, 7, 8, 10, 12,<br>14, 16 mm options for each | | Modularity | Metal femoral component and<br>either an all polyethylene tibial<br>component or metal tibial<br>component with polyethylene<br>insert | Metal femoral component and either an<br>all polyethylene tibial component or<br>metal tibial component with polyethylene<br>insert | N/A | | Packaging Description | | | | | Component | Inner foil pouch laminated out<br>of foil/LLDPE/Polyester<br>materials and vacuumed,<br>packaged inside a Tyvek/blister<br>tray with a foam protector | Double PETG Blister/Tyvek | Inner foil pouches<br>and outer rigid<br>blister trays with Tyvek lids | {6}------------------------------------------------ | Sterility | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------|-------------------| | Sterile Method | Gamma Irradiation | Gas Plasma Sterilization | Gamma Irradiation | | Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | | Shelf Life | 5 Years | 5 Years | 5 Years | | Purpose of Submission | | | | | This submission adds an AOX material option to the existing legally marketed SIGMA High Performance (HP) Partial Knee System (K070267, | | | | | K070849, K061648). The SIGMA HP Partial AOX insert is equivalent to the primary predicate SIGMA HP Partial XLK Insert (K070267) in intended | | | | | use, geometry, design, fixation, and compatibility. The AOX material is similar to the AOX UHMWPE material used in the manufacture of the legally | | | | | marketed ATTUNE® Primary Knee System. All three poly materials conform to ASTM-F648. This submission also includes a labeling update to the | | | | | existing SIGMA HP Partial Knee System IFU. | | | | {7}------------------------------------------------ ### PERFORMANCE DATA # SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofenerotibial Metal/Polyner Porous-Coated Uncenented Prosheses; Guidance for Industry and FDA) on the SIGMA High Performance (HP) Patial Knee AOX Insert to demonstrate substantial equivalence of safety and efficacy with the predicate device: - Biocompatibility . - UHMWPE Material Property Characterization . - Range of Motion/Constraint ● - Contact Area/Stress ● - Wear Testing ● - Pull-Off . The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION Clinical testing was not necessary to demonstrate substantial equivalence. ## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA The subject DePuy SIGMA High Performance Partial Kneets are substantially equivalent to the predicate SIGMA High Performance Partial Knee System.