SMS Cementless Stem

{0}------------------------------------------------ December 2, 2020 Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118 Re: K203041 Trade/Device Name: SMS Cementless Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, KWY, LZY Dated: November 18, 2020 Received: November 19, 2020 Dear Chris Lussier: 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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Sincerely, Vesa Vuniqi 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) K203041 Device Name SMS Cementless Stem ## Indications for Use (Describe) The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases: - . Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia - · Avascular necrosis of the femoral head - · Acute traumatic fracture of the femoral head or neck - · Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty Type of Use (Select one or both, as applicable) X 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. 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}------------------------------------------------ # 3.0 510(k) Summary #### I. Submitter Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66 Contact Person: Stefano Baj, Regulatory Affairs Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: October 6, 2020 Date Revised: October 22, 2020 #### II. Device | Device Proprietary Name: | SMS Cementless Stem | |--------------------------|--------------------------------------------------------------------------------------------------| | Common or Usual Name: | Femoral Stems | | Classification Name: | Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous, uncemented prosthesis | | Primary Product Code: | LZO, MEH, KWY, LZY | | Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360 | | Device Classification | II | #### III. Predicate Device Primary predicate: - . SMS, K181693, K201673 Medacta International SA The following device is referenced: - . Quadra P Collared, K192827, Medacta International SA. #### IV. Device Description The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery. The SMS implants are comprised of the following products: - SMS Cementless Solid Standard Stem (available in 15 sizes from size 1 to 15); and ● - SMS Cementless Solid Lateralized Stem (available in 15 sizes from size 1 to 15). . {4}------------------------------------------------ Both are available on the US market via the clearance - K181693 and K201673. SMS collared solid version, has been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693 and K201673). Quadra P is the collared stem currently marked in US K192827. The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693 and K201673). The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967). The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518). #### V. Indications for Use The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck ● - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip ● arthroplasty, hip resurfacing replacement or total hip arthroplasty. #### VI. Comparison of Technological Characteristics The SMS range extension implants and the predicate devices share the following characteristics: - CCD angle; ● - . cementless: - material of construction; ● - coatings and coatings composition; ● {5}------------------------------------------------ - . biocompatibility: - device usage; - sterility; ● - shelf life; ● - packaging; - sizes: - stem lengths; . SMS Collared is technologically different from the predicate devices as follows: - Medial Collar Shape and Dimensions These differences do not introduce a new worst case from a clinical point of view or with respect to the biomechanical performance of the implants. #### Performance Data VII. The introduction of the SMS collared version does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission: Non-Clinical Studies: - Performance Tests . - o range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants; - o fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery -Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]; - fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components; - pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method о for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. - Coating Tests ● - o ISO 13779-1 Second Edition 2008-10-01 Implants for Surgery Hydroxyapatite -Part 1: Ceramic Hydroxyapatite; and - ASTM F1147-99 Standard Test Method for Tension Testing of Calcium Phosphate o and Metal Coatings. - Pyrogenicity ● - Bacterial Endotoxin Test (LAL test) was conducted according to European о Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and pyrogen test according to USP chapter <151> for pyrogenicity determination; and - the subject devices are not labeled as non-pyrogenic or pyrogen free. o {6}------------------------------------------------ Clinical Studies: - • No clinical studies were conducted. ## VIII. Conclusion Based on the above information, the SMS Collared implants are substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The SMS Collared implants are as safe and effective as the predicate devices, SMS solid stem, (K181693 and K201673) and Quadra P collared (K192827).