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 (K122991).

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?

ConforMIS iTotal CR Knee Replacement System (K094050); ConforMIS iTotal CR Knee Replacement System (K103117); ConforMIS iTotal CR Knee Replacement System (K112780); ConforMIS iTotal CR Knee Replacement System (K113378); ConforMIS iTotal CR Knee Replacement System (K120068); ConforMIS iTotal CR Knee Replacement System (K120316).

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

K122991 · Conformis, Inc. · JWH · Dec 20, 2012 · Orthopedic

Device Facts

Record ID	K122991
Device Name	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Applicant	Conformis, Inc.
Product Code	JWH · Orthopedic
Decision Date	Dec 20, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The iTotal® CR Knee Replacement System 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. The implant is intended for cemented use only.

Device Story

Patient-specific tricompartmental posterior cruciate ligament (PCL) retaining knee replacement system; consists of femoral, tibial, and patellar components. Inputs: patient CT or MR imaging. Transformation: proprietary software (iTotalWorks v4.0, iTotalTib v1.0) designs patient-specific implants and ancillary instrumentation to match patient anatomy. Output: custom-fit CoCrMo femoral/tibial components and UHMWPE patellar component/inserts; patient-specific nylon surgical jigs. Used in clinical settings by orthopedic surgeons for cemented implantation. Benefits: bone-preserving approach; improved fit via patient-specific design; guides bone resection intra-operatively.

Clinical Evidence

Bench testing only. No clinical data was required to demonstrate substantial equivalence. Evidence consists of detailed device description and software verification and validation testing for iTotalWorks v4.0 and iTotalTib v1.0.

Technological Characteristics

Materials: Femoral/Tibial tray (CoCrMo alloy), Tibial inserts/Patellar component (UHMWPE). Design: Patient-specific, tricompartmental, semi-constrained, fixed-bearing, cemented. Instrumentation: Patient-specific nylon jigs. Software: Proprietary design software (iTotalWorks v4.0, iTotalTib v1.0). 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 partial knee implants. Contraindicated for patients whose conditions can be addressed by unicondylar, patellofemoral, or bicompartmental prostheses.

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 Knee Replacement System (K094050)
ConforMIS iTotal CR Knee Replacement System (K103117)
ConforMIS iTotal CR Knee Replacement System (K112780)
ConforMIS iTotal CR Knee Replacement System (K113378)
ConforMIS iTotal CR Knee Replacement System (K120068)
ConforMIS iTotal CR Knee Replacement System (K120316)

Submission Summary (Full Text)

{0}------------------------------------------------ K122991 #### 5.0 510(K) SUMMARY (PAGE 1 OF 5) . :" : # DEC 2 0 2012 | Submitter's Name and Address: | ConforMIS Inc. 11 North Avenue Burlington, MA 01803 | |----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3004153240 | | Date of Summary: | September 24, 2012 | | Contact Person: Telephone Number: Fax Number: | Amita S. Shah, Vice President, Regulatory and Quality Affairs (781) 345-9164 (781) 345-0104 | | Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (KRS) | | Common or Usual Name: | Cruciate Retaining Total Knee Replacement System | | Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis | | 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. The implant is intended for cemented use only. | | Identification of the Legally Marketed Device (Predicate Device): | ConforMIS iTotal CR Knee Replacement System (KRS) Device Class: II Product Code: JWH, OOG Regulation Number: 21 CFR 888.3560 510(k) Number: K094050, K103117, K112780, K113378, K120068, and K120316 | Traditional 510(k) — Modified iTotal® CR Knee Replacement System — lTotalTib v1.0/iTotalWorks v4.0 18 ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 1 {1}------------------------------------------------ ### 510(K) SUMMARY (PAGE 2 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. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patientspecific implant and related instrumentation are designed, that best meet 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 manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE 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 of the cutting of bone. The function and general design features of the patient-specific ancillary instruments remain similar to those described in the predicate 510k notifications i.e. K094050, K103117, K112780, K113378, K120068, and K120316 The product subject of this premarket notification is substantially equivalent to the Total Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 07, 2011, K112780 cleared December 15, 2011, K113378 cleared February 15, 2012, K120068 cleared February 03, 2012, and K120316 cleared April 19, 2012. The following testing was performed to establish substantial equivalence: - Software verification and validation testing of . proprietary software Substantial Equivalence: {2}------------------------------------------------ # 510(K) SUMMARY (PAGE 3 OF 5) : ### Device Comparison : ・ | Characteristic | Predicate iTotal CR Knee Replacement System (K112780 & K120316) | Modified Device iTotal CR Knee Replacement System (This submission) | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The iTotal® CR Knee Replacement System 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. | The iTotal® CR Knee Replacement System 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. | | | The iTotal KRS is intended for cemented use only | The implant is intended for cemented use only | | Intended for Cement Use Only | Yes | Yes | | Product Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) | | Components | • Femoral Component • Metal Backed Tibial Component • Patellar component | • Femoral Component • Metal Backed Tibial Component • Patellar component | | Characteristic | Predicate iTotal CR Knee Replacement System (K112780 & K120316) | Modified Device iTotal CR Knee Replacement System (This submission) | | Materials | Femoral Implant: CoCrMo Metal Backed Tibial Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE All Polymer Patellar Component: UHMWPE | Femoral Implant: CoCrMo Metal Backed Tibial Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE All Polymer Patellar Component: UHMWPE | | Design | Knee joint patellofemorotibial semi- constrained cemented prosthesis | Knee joint patellofemorotibial semi- constrained cemented prosthesis | | Principle of Operation | Cemented Use fixed Bearing Design | Cemented Use fixed Bearing Design | | Patient Matched | Yes | Yes | | Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | | Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs | | Proprietary Software for Femoral Components | iTotalWorks version 3.0 | iTotalWorks version 4.0 | | Proprietary Software for Tibial Components | N/A - manual process | iTotalTib version 1.0 or manual process | / . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . 20 . {3}------------------------------------------------ ## K122991 . ## 510(K) SUMMARY (PAGE 4 OF 5) . . 21 . . : {4}------------------------------------------------ . # 510(K) SUMMARY (PAGE 5 OF 5) | Description 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 iTotalTib | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 iTotal Cruciate Retaining Knee Replacement System with the use of the iTotalWorks v4.0 and iTotalTib v1.0 production software is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 07, 2011 and K112780 cleared Dec 15, 2011, K113378 cleared February 15, 2012, K120068 cleared February 03, 2012, and K120316 cleared April 19, 2012) | . : · · : : . . 22 . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Letter dated: December 20, 2012. ConforMIS, Incorporated % Ms. Amita S. Shah Vice President, Regulatory and Quality Affairs 11 North Avenue Burlington, Massachusetts 01803 Re: K122991 Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG Dated: September 24, 2012 Received: September 26, 2012 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. 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 {6}------------------------------------------------ #### Page 2 - Ms. Amita S. Shah 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. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, # Mark N. Melkerson Mark N. Melkerson · Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K122991 #### Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) Indications for Use: The iTotal® CR Knee Replacement System 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, ucy 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. The 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Krishna Asundi Division of Orthopedic Devices

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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