Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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. September 8, 2023 Conformis, Inc. Mary Kruitwagen Sr Regulatory Affairs Specialist 600 Technology Park Drive Fourth Floor Billerica, Massachusetts 01821 Re: K232426 Trade/Device Name: Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY, OOG Dated: August 10, 2023 Received: August 11, 2023 Dear Mary Kruitwagen: 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. {1}------------------------------------------------ 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 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. # Lixin Liu -S Lixin Liu, Ph.D. 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 Submission Number (if known) K232426 Device Name Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts Indications for Use (Describe) The Identity™ Imprint™ Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans The Ildentity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon. The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired. 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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The letters "ORMIS" are in orange, while the letters "CON" are in black. ## Special 510(k) Summary | 501(k) Number: | K232426 | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name and Address: | Conformis, Inc.<br>600 Technology Park Drive,<br>Fourth Floor<br>Billerica, MA 01821<br>USA | | Main Telephone Number: | 781-345-9164 | | Establishment Registration<br>Number(s): | 3009844603 and 3004153240 | | Date Summary was Prepared: | August 10, 2023 | | Contact Person: | Mary Kruitwagen<br>Sr. Regulatory Affairs Specialist | | Contact Information: | Mary.Kruitwagen@conformis.com<br>781-345-9038 | | Subject Device: Trade/Device<br>Name(s): | Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement<br>System (KRS) with Cruciate Sacrificing (CS) Insert | | Common Name: | Knee Replacement System | | Type of Submission: | Special 510(k) | | Device Class: | Class II | | Regulation Number(s): | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/<br>polymer porous-coated uncemented prosthesis<br><br>21 CFR 888.3560 - Knee joint patellofemorotibial polymer/<br>metal/polymer semiconstrained cemented prosthesis | | Product Codes: | • MBH: Knee Joint, Patellofemorotibial, Metal/Polymer porous<br>coated uncemented prothesis<br>• JWH: Knee joint patellofemorotibial polymer/metal/polymer<br>semiconstrained cemented prosthesis<br>• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained,<br>cemented, polymer + additive/metal/polymer + additive<br>• OOG: Knee Arthroplasty Implantation System | | Classification Panel: | Orthopedics | | Manufacturing Site: | Conformis Inc.<br>600 Research Drive<br>Wilmington, Ma. 01887<br>USA | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written below it. The first three letters of the word are in black, while the last four letters are in orange. Identity™ Imprint™ Porous Total Knee Replacement System, Identity Primary Predicate Device: Imprint Porous Cruciate Retaining Total Knee Replacement System Primary Predicate 510(k): K223316 Primary Predicate Regulation 21 CFR 888.3565, 21 CFR 888.3560 Number(s) Primary Predicate Classification ● MBH: Knee Joint, Patellofemorotibial, Metal/Polymer porous Names and Product Codes: coated uncemented prothesis . JWH: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis ● OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive . OOG: Knee Arthroplasty Implantation System Secondary Predicate Device: ldentity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System with CS insert Second Predicate 510(k): K230844 Reference Predicate Regulation 21 CFR 888.3560 Number(s) Reference Predicate Classification ● JWH: Knee joint patellofemorotibial polymer/metal/polymer Names and Product Codes: semiconstrained cemented prosthesis . OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive ● OOG: Knee Arthroplasty Implantation System Third Predicate Device: iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS) Third Predicate 510(k): K230846 Third Predicate Regulation 21 CFR 888.3560 Number(s) . JWH: Knee joint patellofemorotibial polymer/metal/polymer Third Predicate Classification Names and Product Codes: semiconstrained cemented prosthesis . OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive - OOG: Knee Arthroplasty Implantation System ● #### Device Description: The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is proposed to be a modification from Identity™ Imprint™ Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316) to be compatible with the Identity™ Imprint™ Cruciate Sacrificing (CS) Tibial Insert cleared in K230844. This submission also seeks the inclusion of the cleared AIM2Surf software (K230846) for use with the subject device. This software is used by CAD to do preliminary surface planning. No software version change is required as the surface planning is unchanged between the predicate and subject devices. The Porous Ancillary Reusable instrument tray was modified and clearance of the modification is also sought. The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrficing (CS) Insert, is a knee replacement system including standardized implant sizes {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written in black and orange. The "C" is made up of two curved lines, one orange and one black, that overlap each other. The word "CONFORMIS" is written in a sans-serif font, with the "CONFORM" in black and the "IS" in orange. combined with standard and patient-specific ancillary surgical instrumentation. It is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (CT scan), an Identity Imprint Porous implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CPTi) scaffold on the interior surface. The tibial tray is manufactured from a titanium alloy (Ti6Al4V-EL), with a CPTi porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6A4V-ELI) and CPTi porous metal backing. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary. The ldentity™ Imprint™ Porous Knee Replacement System is compatible with cemented Identity™ Imprint™ CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique. The subject CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately. The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment). The Cruciate Sacrificing tibial insert of iPoly™ XE is offered in thicknesses of 6mm to 18mm and is the same insert as cleared with Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with CS insert (K230844). #### Indications for Use: The Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: - . Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. - Post traumatic loss of joint function. - . Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral implants. - . Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans Conformis Identity™ Imprint™ Porous CS Insert Special 510K {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written in black and orange below it. The letters "CONFOR" are in black, while the letters "MIS" are in orange. The Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon. The CS insert option should be utilized when additional anterior-posterior constraint is desired. #### Technological Characteristics: The focus of this submission is to claim compatibility of the cleared of Cruciate Sacrificing tibial insert with ldentity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS)(K223316). There is no change to either the Cruciate Sacrificing Tibial Insert (K230844) or the Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) (K223316). Micromotion testing was performed to confirm that the CS insert can function as intended. The subject device proposes the 1.0 version of the AIM2Surf software cleared in K230846, which does preliminary bone surface planning, for use with the subject Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS). No version change is need as there is no difference in the surface planning. No software is necessary for the CS insert, however the AIM2Surf is seeking clearance with this submission for the subject Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert. #### Non-Clinical Performance Evaluation: The following testing was performed: - Tibial Micromotion Testing #### Conclusion: Based on a comparison of the intended use and technological characteristics of the subject device to predicate devices, and the results of the confirmatory testing, it is concluded that the proposed Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is considered substantially equivalent to the predicate devices.