Latitud™ Hip Replacement System

{0}------------------------------------------------ Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Meril Healthcare Pvt. Ltd. Yamini Patel Manager - Regulatory Affairs Survey No. 135/2/B & 174/2, H1-H3, Meril Park, Muktanand Marg, Chala Vapi. Gujarat 396191 India Re: K222436 Trade/Device Name: Latitud™ Hip Replacement System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO Dated: April 14, 2023 Received: April 14, 2023 Dear Yamini Patel: 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. 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. 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 {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, Image /page/1/Picture/5 description: The image shows the words "Limin Sun-S" in a large, sans-serif font. The text is black against a white background. The words are arranged horizontally, with "Limin" on the left, "Sun" in the middle, and "-S" on the right. The letters are evenly spaced and easy to read. Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222436 ## Device Name Latitud™ Hip Replacement System ### Indications for Use (Describe) The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Congenital hip dysplasia. - Acute traumatic fracture of the femoral head or neck. - Certain cases of Ankylosis. - Dislocation of the hip. - Correction of functional deformity. - Revision of failed joint reconstruction or treatment. - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur. Note: - · The Titanium coated Modular Shell is intended for press-fit, uncemented use only. - · The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. - · The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. - · The Cemented Femoral stem is intended for cemented use only. - · The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. · The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem. • The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem. · The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell. - · The Centralizer and Cement Restrictor are intended for use with cemented stem only. 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. {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, 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image features the word "Meril" in a clean, sans-serif font. The word is presented in a bright white color against a solid blue background. Above the "i" in "Meril" is a small, circular dot in a contrasting yellow-orange color, adding a subtle visual accent to the logo. # 510(k) Summary This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92. # 1. Meril Healthcare Private Limited Survey No. 135/2/B & 174/2, First Floor, H1-H3, Meril Park, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA #### Primary Contact Person: 2. Yamini Patel Manager- Regulatory Affairs E mail: yamini.patel@merillife.com Cell: +91 9714408139 #### Secondary Contact Person: 3. Gayathri Nair DGM- Regulatory Affairs / Quality Assurance E mail: gayathri.nair@merillife.com Cell: +91 9909033393 #### Date prepared: 09 May 2023 4. #### Device information: ട്. Proprietary Name: Latitud™ Hip Replacement System Common / Usual Name: Hip Joint Prosthesis {5}------------------------------------------------ Image /page/5/Picture/1 description: The image provides information on the classification name, product codes, and device class of hip joint prostheses. The classification names include hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358, hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353, and hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350. The product codes are LPH, JDI, and LZO, and the device class is Class II. #### Predicate Devices: 6. | Component | Predicate Device | Manufacturer | 510(K)<br>Number | |---------------------------------------------------------------------------------------------|------------------------------------|-------------------------------|------------------| | Latitud™ Hip<br>Replacement System<br>(Hydroxyapatite<br>Coated Uncemented<br>Femoral Stem) | Latitud™ Hip<br>Replacement System | Meril Healthcare Pvt.<br>Ltd. | K172857 | #### Device Description: 7. The Latitud™ Uncemented Femoral Stem is fabricated from Titanium alloy - ELI (Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with its 510(k) cleared Latitud™ Cobalt Chromium alloy and Biolox® delta Modular femoral head (Cleared under K172857). This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with neck angles {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The word is in white text on a blue background. There are two dots above the "i" in "Meril", one is yellow and the other is white. of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only. #### Intended use/Indications: 8. The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components. # Total hip replacement is indicated for the following conditions: - > Non-inflammatory degenerative joint diseases including osteoarthritis, posttraumatic arthritis and avascular necrosis. - A Rheumatoid arthritis. - Congenital hip dysplasia. A - > Acute traumatic fracture of the femoral head or neck. - A Certain cases of Ankylosis. - A Dislocation of the hip. - Correction of functional deformity. A - A Revision of failed joint reconstruction or treatment. - Treatment of non-union, femoral neck and trochanteric fractures of the proximal A femur. ## Note: - The Titanium coated Modular Acetabular Shell is intended for press-fit, . uncemented use only. - . The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, Uncemented use only - The Proximally Coated Uncemented Femoral Stem is intended for press-fit, . Uncemented use only. - The Cemented Femoral stem is intended for cemented use only. - The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. . {7}------------------------------------------------ # Meri - The CoCr Modular Femoral Head is intended to articulate with Modular . Acetabular Liner to mate with uncemented stem or cemented stem. - . The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular Liner to mate with uncemented stem or cemented stem. - . The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell. - . The Centralizer and Cement Restrictor are intended for use with cemented stem only. #### 9. Comparison of Technological characteristics: The subject device is substantially equivalent to legally marketed predicate device with respect to intended use, materials, device design, technological characteristics and manufacturing process including sterilization. The only difference between the subject device and the legally marketed device is the facility where the coating is performed. However, difference in coating facility between subject device and predicate device, does not raise new question of safety and effectiveness # 10. Non clinical Performance data: The subject device was subjected to non-clinical performance testing to evaluate device function/mechanical performance in accordance with applicable ASTM and ISO standard and FDA guidance. The tests include testing on the subject device and the HA powder. Testing on subject device includes; - Mechanical tests: . - > Bonding Strength (ASTM F1147-05 (Reapproved 2017)e1) - Shear static strength (ASTM F1044-05 (Reapproved 2017)e1) A - > Fatigue Shear test (ASTM F1160-14 (Reapproved 2017)e1) - > Fatigue bending test (ASTM F1160-14 (Reapproved 2017)e1) {8}------------------------------------------------ - . Morphology tests: Meril - A Thickness and Porosity (ASTM F1854-15) - Roughness Ra/Rt (ISO 4288- 1998) A - > Scanning Electron Microscope (SEM) (FDA Guidance*) - . Chemical tests: - > Trace elements and heavy metals by ICP (ISO 13779-2 (2018), ISO 13779-3 (2018)) - > Ca/P ratio and Phases and Crystallinity by XRD (ISO 13779-2 (2018), ISO 13779-3 (2018)) - A Fourier-transform infrared spectroscopy (FTIR) (FDA Guidance*) - > Solubility (ISO 13779-6 (2015)) - > Dissolution (ASTM F1926/F1926M-14) - . Testing on HA powder includes; - A Granulometry by sieving (ISO 2591-1 (1998)) - Granulometry by laser diffraction (ISO 24235 (2007)) A - A Morphology by Scanning Electron Microscope (SEM) (ISO 13779-6 (2015)) - > Trace elements and heavy metals by ICP (ISO 13779-3 (2018)) - > Ca/P ratio & Phases and Crystallinity by XRD (ISO 13779-3 (2018)) - > Molecular constitution by Fourier-transform infrared spectroscopy (FTIR) (FDA Guidance*) *FDA guidance document- "510(k) Information needed for Hydroxyapatite coated orthopedic implants. February 1997" #### 11. Summary of Biocompatibility testing: - · Cytotoxicity Test ISO 10993-5 - · Skin Sensitization Study ISO 10993-10 - · Acute irritation/Intracutaneous reactivity test ISO 10993-23 - · Acute systemic toxicity study ISO 10993-11 - · Material mediated pyrogenicity ISO 10993-11, USP General Chapter <151> - · Sub-chronic systemic toxicity test ISO 10993-11 {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The letters are white, and the background is light blue. There are two dots above the "i" in "Meril", one yellow and one white. - Bone Implantation Study ISO 10993-6 - Bacterial Reverse Mutation Test ISO 10993-3 - · In vitro Mammalian Chromosomal Aberration Test ISO 10993-3 #### Conclusion: 12. Based on performance testing results and similarities in intended use, manufacturing process, device design/technological characteristics, materials, and sterilization method, the subject device is considered substantially equivalent to the previously cleared predicate device.