Who is the manufacturer of ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM?

Conformis, Inc. filed the 510(k) submission for ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K140423).

What is the FDA product code for 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 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM?

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

What are the predicate devices for ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM?

iTotal CR Knee Replacement System (K131467); iTotal CR Knee Replacement System (K131019); iTotal CR Knee Replacement System (K122991); iTotal CR Knee Replacement System (K122033); iTotal CR Knee Replacement System (K120068).

Who can help prepare an FDA 510(k) submission like 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.

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K140423 · Conformis, Inc. · JWH · May 27, 2014 · Orthopedic

Device Facts

Record ID	K140423
Device Name	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Applicant	Conformis, Inc.
Product Code	JWH · Orthopedic
Decision Date	May 27, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The iTotal® 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.

Device Story

The iTotal CR KRS is a patient-specific, tricompartmental, posterior cruciate ligament (PCL) retaining knee replacement system. Input consists of patient CT or MR scans; proprietary software processes these images to design patient-specific femoral, tibial, and patellar implants and nylon surgical jigs. The system is used in clinical settings by orthopedic surgeons for total knee arthroplasty. The surgeon uses the patient-specific jigs intra-operatively to guide bone cuts and position components. The output is a custom-fit cemented implant that restores joint function and stability. Benefits include improved geometric and anatomic matching to the patient's specific knee structure compared to off-the-shelf implants.

Clinical Evidence

Bench testing only. No clinical data was required. Substantial equivalence was demonstrated through software verification and validation testing of the proprietary design software and design validation via cadaveric testing.

Technological Characteristics

Patient-specific, tricompartmental, semi-constrained, cemented knee prosthesis. Materials: Femoral component (CoCrMo alloy), Tibial tray (CoCrMo alloy), Tibial/Patellar inserts (UHMWPE or Vitamin E infused iPoly XE). Includes patient-specific nylon surgical jigs. Software-driven design process based on patient CT/MR imaging. Sterilization: Ancillary instruments provided sterile.

Indications for Use

Indicated for patients with knee joint pain and disability requiring total knee replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, osteonecrosis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, or failed prior knee implants (osteotomies, hemiarthroplasties, or partial replacements). Contraindicated for patients where anatomic landmarks for alignment are not identifiable on imaging.

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

iTotal CR Knee Replacement System (K131467)
iTotal CR Knee Replacement System (K131019)
iTotal CR Knee Replacement System (K122991)
iTotal CR Knee Replacement System (K122033)
iTotal CR Knee Replacement System (K120068)

Related Devices

K120068 — CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) · Conformis, Inc. · Feb 3, 2012
K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Sep 27, 2012
K122991 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Dec 20, 2012
K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · Mar 25, 2016
K180906 — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · May 16, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ K140423 (page 1/6) K140423 # MAY 2 7 2014 | 6.0 510(K) SUMMARY (PAGE 1 OF 6) | MAY 27 20 | |----------------------------------|-----------| |----------------------------------|-----------| | Submitter's Name and Address: | ConforMIS Inc. 28 Crosby Drive Bedford, MA 01730 | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3009844603 and 3004153240 | | Date of Summary: | February 11, 2014 | | Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs | | Telephone Number: | (781) 345-9164 | | Fax Number: | (781) 345-0147 | | Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) | | Common Name: | Cruciate Retaining 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 Code: 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 prosthesis that have a femoral component 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. | : 1 of 6 {1}------------------------------------------------ ### 510(K) SUMMARY (PAGE 2 OF 6) Indications for Use: The iTotal® 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. ldentification of the Legally Marketed Device (Predicate Device): ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: = JWH, OOG, OIY Product Code: Regulation Number: 21 CFR 888.3560 510(k) Number: K131467, K131019, K122991, K122033, and K120068 {2}------------------------------------------------ ### 510(K) SUMMARY (PAGE 3 OF 6) | 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 (either CT or MR scans) and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component 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 a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™). For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone. The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K131467 and K131019. | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | The product subject of this premarket notification is substantially equivalent to the iTotal CR KRS (K131467, cleared July 18, 2013; K131019, cleared May 24, 2013; K122991, cleared December 20, 2012; K122033, cleared September 27, 2012 and K120068, cleared February 3, 2012). The following testing was performed to establish substantial equivalence: Software verification and validation testing of proprietary | - Software verification and validation testing of proprietary software . - Design validation via cadaveric testing . • 45 . 3 of 6 . . {3}------------------------------------------------ # 510(K) SUMMARY (PAGE 4 OF 6) ## Device Comparison | Characteristic | Predicate iTotal Cruciate Retaining Knee Replacement System (K131467, K131019, K122991, K122033 & K120068) | iTotal Cruciate Retaining Knee Replacement System (This submission) | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The iTotal 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. | The iTotal 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. | | Principle of Operation | Cemented Use Fixed Bearing Design | Cemented Use Fixed Bearing Design | | Product Classification | 21 CFR 888.3560 (JWH, OOG, OIY) | 21 CFR 888.3560 (JWH, OOG, OIY) | | Components and Materials | • Femoral Implant: CoCrMo • Metal Backed Tibial Components: o Tibial tray: CoCrMo o Tibial dual or single piece inserts: UHMWPE or iPoly XE • All Polymer Patellar Component: UHMWPE or iPoly XE | • Femoral Implant: CoCrMo • Metal Backed Tibial Components: o Tibial tray: CoCrMo o Tibial dual or single piece inserts: UHMWPE or iPoly XE • All Polymer Patellar Component: UHMWPE or iPoly XE | | Characteristic | Predicate iTotal Cruciate Retaining Knee Replacement System (K131467, K131019, K122991, K122033 & K120068) | iTotal Cruciate Retaining Knee Replacement System (This submission) | | Design | Knee joint patellofemorotibial semi- constrained cemented prosthesis | Knee joint patellofemorotibial semi- constrained cemented prosthesis | | Patient Matched | Yes | Yes | | Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | | Proprietary Software for Femoral Components | iTotalWorks version 4.0 or Manual Process | iTotalWorks version 5.0 or Manual Process | | Proprietary Software for the Femoral iJigs | iTotal FemJigs version 1.5 or Manual Process | iTotal FemJigs version 2.0 or Manual Process | | Proprietary Software for Tibial Components | iTotalTib version 1.0 or Manual Process | iTotalTib version 2.0 or Manual Process | | Proprietary Software for Tibial iJigs | N/A - Manual Process | iTotal TibJigs version 1.0 or Manual Process | | Proprietary Software for Patient-Specific Surgical Plan | iTotal iView version 1.0 or Manual Process | iTotal iView version 2.0 or Manual Process | 1 . {4}------------------------------------------------ # 510(K) SUMMARY (PAGE 5 OF 6) Device Comparison {5}------------------------------------------------ ## 510(K) SUMMARY (PAGE 6 OF 6) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Description and Conclusion of Testing: | Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use: Detailed software description and software verification and validation testing of proprietary software iTotalWorks Detailed software description and software verification and validation testing of proprietary software iTotal FemJigs Detailed software description and software verification and validation testing of proprietary software iTotalTib Detailed software description and software verification and validation testing of proprietary software iTotal TibJigs Detailed software description and software verification and validation testing of proprietary software iTotal iView Design validation via cadaveric testing | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 intended use. Clinical data is not necessary to demonstrate substantial equivalence. | | Conclusion: | Based on the testing conducted, it is concluded that the modified iTotal CR KRS is substantially equivalent to the predicate iTotal CR KRS (K131467 cleared July 18, 2013, K131019 cleared May 24, 2013, K122991 cleared December 20, 2012, K122033 cleared September 27, 2012, and K120068 cleared February 03, 2012) | . {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 27, 2014 ConforMIS. Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford. Massachusetts 01730 Re: K140423 Trade/Device Name: 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 23, 2014 Received: April 24, 2014 Dear Ms. Shalı: 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 tiability 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 (reporting of medical {7}------------------------------------------------ ### Page 2 - Ms. Amita Shah 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. # Sincerely yours, Lori A. Wiggins for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Indications for Use K140423 510(k) Number (if known): _ Device Name: iTotal CR Knee Replacement System Indications for Use: The iTotal 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. Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Casey L. Hanley, Ph.D Division of Orthopedic Devices