INHANCE INTACT™

{0}------------------------------------------------ December 23, 2024 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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Depuy Ireland UC % Sanjay Shah Regulatory Affairs NPD Depuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582 Re: K243248 Trade/Device Name: Inhance Intact™ Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder ioint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC, PAO, MBF, KWT, KWS, HSD Dated: October 4, 2024 Received: October 11, 2024 Dear Sanjay Shah: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, Joseph P. Russell - Digitally signed by Joseph P. Russell -S S Date: 2024.12.23 14:45:23 -05'00' for: Farzana Sharmin, PhD 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 {3}------------------------------------------------ #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) #### K243248 Device Name INHANCE INTACT TM Indications for Use (Describe) The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: - · Osteoarthritis - · Post-traumatic arthrosis - · Focal avascular necrosis of the humeral head - · Previous surgeries of the shoulder that do not compromise the fixation Fixation Methods: The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage. 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. 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}------------------------------------------------ | | e | 1, 2 | |--|---|------| | | | | 510(k) Summary Prepared on: 2024-12-23 ## Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Depuy Ireland UC | | | | | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--|---------------------|--| | Applicant Address | Loughbeg Ringaskiddy Ringaskiddy Co. Cork Munster Ireland | | | | | | Applicant Contact Telephone | (612) 812-6462 | | | | | | Applicant Contact | Mr. Sanjay Shah | | | | | | Applicant Contact Email | sshah164@its.jnj.com | | | | | | Correspondent Name | | Depuy Orthopaedics, Inc. | | | | | Correspondent Address | | 700 Orthopaedic Dr. Warsaw IN 46582 United States | | | | | Correspondent Contact Telephone | | (612) 812-6462 | | | | | Correspondent Contact | | Mr. Sanjay Shah | | | | | Correspondent Contact Email | | sshah164@its.jnj.com | | | | | Device Name<br>21 CFR 807.92(a)(2) | | | | | | | Device Trade Name | INHANCE INTACT ™ | | | | | | Common Name | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral<br>Stem With No Diaphyseal Incursion, Semi-Constrained | | | | | | Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis | | | | | | Regulation Number | 888.3660 | | | | | | Product Code(s) | PKC, PAO, MBF, KWT, KWS | | | | | | Legally Marketed Predicate Devices<br>21 CFR 807.92(a)(3) | | | | | | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | | Product Code | | | K203108 | Ignite Stemless Anatomic Shoulder System | | | PKC | | | K212933 | INHANCE Hybrid Anatomic Glenoid Implant | | | MBF | | | Device Description Summary | | | | 21 CFR 807.92(a)(4) | | The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System. The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures. {5}------------------------------------------------ The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface. # Intended Use/Indications for Use ## 21 CFR 807.92(a)(5) The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is in anatomic total shoulder replacement procedures to address the following: - · Osteoarthritis - · Post-traumatic arthrosis - · Focal avascular necrosis of the humeral head. - · Previous surgeries of the shoulder that do not compromise the fixation Fixation Methods: The humeral stemless anchor is intended for cementless use. The anatomic hybrid glenoid are intended for cemented use only. The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process an # Indications for Use Comparison The indications for use are the same as the predicate device. ## Technological Comparison The INHANCE Stemless Anatomic Shoulder System with INHANCE INTACT instruments are substantially equivalent to the predicate device (K203108 and K212933) in regard to their intended use, indications for use, material, manufacturing process and performance. The implant components of the subject device system are identical to those of the predicate device as thev remain unchanged. The INHANCE INTACT instruments have new design and specification compared to predicate devices instruments. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions. # Non-Clinical and/or Clinical Tests Summary & Conclusions The implant components of the INHANCE Shoulder System are identical to the implant components of the predicate device. This submission includes additional instruments. The INHANCE INTACT Instruments underwent non-clinical testing and analyses to support a determination of substantial equivalence to the predicate device. The following were completed: Biocompatibility Assessments: The contact classification for the subject devices is Instrument, Bone/Tissue with limited duration (<24 hours). A Biocompatibility Assessment was completed and provided per ISO 10993-1 and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The devices were found to be biocompatible. Bench Testing: Design equivalence, equivalence of use of the device, material rationale and biocompatibility evaluation demonstrate substantial equivalence. Clinical testing was not required to demonstrate substantial equivalence. A comparison of the subject and predicate devices, including comparison of the intended use, technological characteristics, and nonclinical testing results has demonstrated that the subject devices have a safety and effectiveness profile equivalent to that of the predicate devices. Thus, the subject devices are substantially equivalent to the predicate devices. ### 21 CFR 807.92(a)(6)