← Product Code [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX) · K092441 # MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM (K092441) _Conformis, Inc. · HSX · Sep 9, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K092441 ## Device Facts - **Applicant:** Conformis, Inc. - **Product Code:** [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX.md) - **Decision Date:** Sep 9, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3520 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ConforMIS Unicondylar Knee Repair System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee repair include those with: joint impairment due to osteoarthritis or traumatic arthritis of the knee; previous femoral condyle or tibial plateau fracture, creating loss of function and; valgus or varus deformity of the knee. This implant is intended for cemented use only. ## Device Story Patient-specific unicondylar knee replacement system; utilizes MRI or CT scan images to design personalized femoral and tibial components; proprietary software analyzes patient anatomy to customize bone-contacting and articular surfaces; components include CoCrMo femoral component and either all-polymer (UHMWPE) or metal-backed (CoCrMo tray with UHMWPE insert) tibial components; intended for cemented use in one knee compartment; physician-operated; provides personalized fit to match patient-specific anatomy; aims to restore joint function in patients with osteoarthritis or traumatic arthritis. ## Clinical Evidence Bench testing only. No clinical data presented. ## Technological Characteristics Materials: Cobalt chromium molybdenum (CoCrMo) alloy, ultra-high molecular weight polyethylene (UHMWPE). Design: Patient-specific, personalized to anatomy via MRI/CT imaging. Connectivity: None. Sterilization: Not specified. Software: Proprietary design software for patient-specific implant geometry. ## Regulatory Identification A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027). ## Predicate Devices - iUni Unicondylar Knee Repair System ([K043570](/device/K043570.md)) - iUni Unicondylar Knee Repair System ([K063432](/device/K063432.md)) - iUni Unicondylar Knee Repair System ([K072368](/device/K072368.md)) - iUni Unicondylar Knee Repair System ([K072586](/device/K072586.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Ko9a441 # SEP 0 Y 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . #### 6.0 510(k) SUMMARY ## Page 1 of 2 This 510{k) Summary for the ConforMlS® Unicondylar Knee Repair System (iUni® KRS) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | Submitter's Name and Address: | ConforMIS Inc.
2 Fourth Ave.
Burlington, MA 01804 | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Amita S. Shah
Director, Quality Assurance | | Date: | August 7, 2009 | | Name of Medical Device: | Device Regulation: 21 CFR 888.3520 | | | Product Code: HSX | | | Common/Usual Name: Knee joint femorotibial metal/polymer non-
constrained cemented prosthesis. | | | Proprietary Name: ConforMIS Unicondylar Knee Repair System (iUni
KRS) | | Device Classification: | In accordance with per 21 CFR 888.3520, a knee joint femorotibial
metal/polymer non-constrained cemented prosthesis is classified by the
FDA as a Class II Medical Device. | | Indications for Use: | The ConforMIS Unicondylar Knee Repair System (iUni KRS) with curved
tibial insert is intended for use in one compartment of the osteoarthritic
knee to replace the damaged area of the articular surface in patients
with evidence of adequate healthy bone sufficient for support of the
implanted components. | | | Candidates for unicondylar knee repair include those with:
| | | This implant is intended for cemented use only. | . {1}------------------------------------------------ # 510(k) SUMMARY Page 2 of 2 Device Description: The ConforMlS Unicondvlar Knee Repair System (iUni KRS) with curved tibial insert is composed of individually packaged femoral and tibial components. The femoral component is manufactured of cobalt chromium molybdenum (CoCrMo) alloy. The tibial implant is offered in two configurations; an all polymer (UHMWPE) configuration and metal-backed configuration. The Metal-backed Tibial implant consists of two components: a CoCrMo tibial tray and an ultra-high molecular weight polyethylene (UHMWPE) tibial trav insert. The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan. In this manner, the implant is personalized on its bone contact and articular surfaces to match a patient's anatomy, thus becoming patient specific. Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the currently marketed iUni Unicondvlar Knee Repair System (reference K043570. K063432, K072368 and K072586). Safety and Performance: The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a bird or a person with outstretched arms, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 SEP 0 Y 2009 ConforMIS. Inc. % Ms. Amita Shah Director, Quality Assurance 2 Fourth Avenue Burlington, Massachusetts 01803 Re: K092441 Trade/Device Name: ConforMIS® iUni® Unicondylar Knee Repair System (iUni KRS) Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: August 6, 2009 Received: August 10, 2009 Dear Ms. 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 (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. 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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ### Page 2 - Ms. Amita Shah If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark N. Me kerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 5.0 INDICATION FOR USE STATEMENT # 510(k) Number (if known): Device Name: ConforMIS® iUni® Unicondylar Knee Repair System (iUni KRS) KO424 ### Indications for Use: The ConforMIS Unicondylar Knee Repair System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee repair include those with: - joint impairment due to osteoarthritis or traumatic arthritis of the knee . - . previous femoral condyle or tibial plateau fracture, creating loss of function and - � valgus or varus deformity of the knee. This implant is intended for cemented use only. Prescription Use_ × (Part 21 CFR 801 Subpart D) ( AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Joutte for mxn (Division Sign-dit) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K092441 Special 510(k) - iUni® KRS - Unicondylar Knee Repair System 23 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K092441](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K092441) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com