Who is the manufacturer of Conformis iTotal Cruciate Retaining (CR) Knee Replacement System?

Conformis, Inc. filed the 510(k) submission for Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (K180906).

What is the FDA product code for Conformis iTotal Cruciate Retaining (CR) Knee Replacement System?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Conformis iTotal Cruciate Retaining (CR) Knee Replacement System?

510(k) clearance (submission type: Special).

What are the predicate devices for Conformis iTotal Cruciate Retaining (CR) Knee Replacement System?

Conformis iTotal CR KRS (K161366).

Who can help prepare an FDA 510(k) submission like Conformis iTotal Cruciate Retaining (CR) Knee Replacement System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System

K180906 · Conformis, Inc. · JWH · May 16, 2018 · Orthopedic

Device Facts

Record ID	K180906
Device Name	Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Applicant	Conformis, Inc.
Product Code	JWH · Orthopedic
Decision Date	May 16, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) 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 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. This implant is intended for cemented use only.

Device Story

Patient-specific, tricompartmental, PCL-retaining knee replacement system; includes femoral, tibial, and patellar components. Input: patient imaging data. Process: proprietary software (iTotalWorks, iTotalFem, iTotalTib, iView) transforms imaging into patient-specific implant designs and surgical plans (iJigs) to match patient anatomy. Output: custom-manufactured implants and single-use manual surgical instruments. Used in clinical settings by orthopedic surgeons to guide bone cuts and component positioning. Benefits: improved fit via patient-specific geometry; restores joint function/stability in patients with severe knee disease.

Clinical Evidence

Bench testing only. Software verification and validation testing performed to confirm performance of updated proprietary software modules.

Technological Characteristics

Materials: Cobalt chromium molybdenum (CoCrMo) alloy, UHMWPE, or iPoly XE (vitamin E infused UHMWPE). Design: Patient-specific, tricompartmental, semi-constrained, cemented. Components: Femoral, tibial (metal tray + polyethylene inserts), patellar. Connectivity: Proprietary CAD software modules for patient-specific design. Sterilization: Not specified.

Indications for Use

Indicated for patients with knee joint pain/disability due to osteoarthritis, traumatic/rheumatoid arthritis, osteonecrosis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, or failed prior implants/osteotomies. Requires identifiable anatomic landmarks on imaging. Cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

Conformis iTotal CR KRS (K161366)

Related Devices

K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Nov 14, 2014
K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · Mar 25, 2016
K160025 — iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · Mar 7, 2016
K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) · Conformis, Inc. · Jul 15, 2016
K153217 — ConforMIS iTotal Posterior Stabilized Knee Replacement System · Conformis, Inc. · Jan 7, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ May 16, 2018 Image /page/0/Picture/1 description: The image contains 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 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. Conformis, Inc. Emmanuel Nyakako Sr. Vice President, Quality and Regulatory 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821 Re: K180906 Trade/Device Name: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: April 4, 2018 Received: April 6, 2018 Dear Emmanuel Nyakako: 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. 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 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); 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. {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180906 #### Device Name Conformis iTotal Cruciate Retaining (CR) Knee Replacement System #### Indications for Use (Describe) The iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) 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 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. This implant is intended for cemented use only. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ # 510(K) SUMMARY (PAGE 1 OF 5) | Submitter's Name and Address: | Conformis, Inc. 600 Technology Park Dr. Billerica, MA 01821 | | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Establishment Registration Number: | 3009844603 and 3004153240 | | | Date 510(k) Summary was Prepared: | April 4, 2018 | | | Contact Person: | Emmanuel O. Nyakako, Sr. Vice President, Quality and Regulatory | | | Telephone Number: Fax Number: | (781) 345-9164 (781) 345-0147 | | | Name of the Device(s): | Conformis® iTotal® Cruciate Retaining Knee Replacement System (iTotal CR KRS) | | | Common Name(s): | Knee Replacement System | | | Regulatory Status and Regulation Number: | Class II 21 CFR 888.3560 | | | Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis | | | Device Classification: | Product Codes: JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. OOG: Knee Arthroplasty Implantation System. Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive. This generic type of device includes prostheses that have a femoral implant made of alloys, such as cobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellar resurfacing component made of ultra-high molecular weight polyethylene plus an additive, such as a-tocopherol. | | | Indications for Use: | The iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) 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. This implant is intended for cemented use only. | | | Identification of the | Conformis iTotal CR Knee Replacement System (iTotal CR KRS) | | | Legally Marketed | | | | Device(s) (Predicate | Device Class: II | | | Device(s)): | Product Code: JWH, OOG, OIY | | | | Regulation Number: 21 CFR 888.3560 | | {4}------------------------------------------------ # 510(K) SUMMARY (PAGE 2 OF 5) 510(k) Number: K161366 {5}------------------------------------------------ ### 510(K) SUMMARY (PAGE 3 OF 5) Device Description: The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component. > Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE. > For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately. The function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366. {6}------------------------------------------------ ### 510(K) SUMMARY (PAGE 4 OF 5) Comparison Summary of Technological Characteristics and Modifications Proposed: The proposed iTotal CR KRS and predicate iTotal CR KRS have the same technological characteristics. There have been no changes to the proposed iTotal CR KRS device with respect to design, materials or methods of manufacture, packaging, or sterilization. Modifications, which represent improving manufacturing efficiencies, are primarily focused on increasing automation of the CAD manufacturing processes via the proprietary software modules as shown in Table 8-1 below. | Characteristic | Predicate iTotal CR KRS (K161366) | Proposed iTotal CR KRS | |---------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------| | Generation of Femoral Implant | iTotalWorks 5.1 and Fem Addin or Manual CAD Process | iTotalWorks 6.0 & iTotalFem CR 1.0 or Manual CAD Process | | Generation of Femoral iJigs | iTotalWorks 5.1 & iTotal FemJigs 3.0 or Manual CAD Process | iTotalWorks 6.0 and iTotalFem CR 1.0 or Manual CAD Process | | Generation of Tibial Implants and iJigs | iTotalTib CR 4.3 or Manual CAD Process | iTotalTib CR 5.0 or Manual CAD Process | | Generation of Patient-Specific Surgical Plan (iView) | iTotal CR iView 3.0 or Manual CAD Process | iTotal CR iView 4.0 or Manual CAD Process | Table 8-1: Comparison Between the Proposed and Predicate Device {7}------------------------------------------------ ## 510(K) SUMMARY (PAGE 5 OF 5) | Substantial Equivalence: | 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 can be considered substantially equivalent to the predicate device for its intended use. The following non-clinical laboratory testing was performed: Software verification and validation testing of proprietary software | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion: | Based on the testing conducted, it is concluded that the proposed | iTotal Cruciate Retaining Knee Replacement System is substantially equivalent to the predicate iTotal Cruciate Retaining Knee Replacement System (K161366, cleared June 14, 2016).