iTotal Cruciate Retaining (CR) Knee Replacement System

K153721 · Conformis, Inc. · JWH · Mar 25, 2016 · Orthopedic

Device Facts

• Record ID: K153721
• Device Name: iTotal Cruciate Retaining (CR) Knee Replacement System
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 25, 2016
• 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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee - Post traumatic loss of joint function. - Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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. Inputs: patient imaging scans. Process: proprietary software (iFit iTotalTib CR) designs patient-specific implants and manual surgical instruments (iJigs) to match patient anatomy. Output: custom-fit implants and surgical guides. Used in clinical settings by orthopedic surgeons for total knee arthroplasty. Implants are cemented. Benefits: improved fit to patient-specific geometry; assists in intraoperative positioning and bone cutting. Software automates CAD manufacturing processes.

Clinical Evidence

No clinical data. Substantial equivalence established via device description and non-clinical software verification and validation testing.

Technological Characteristics

Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE or Vitamin E infused highly cross-linked polyethylene (iPoly XE) (inserts/patellar). Design: Patient-specific, semi-constrained, cemented. Connectivity: Proprietary software-driven CAD design. Sterilization: Not specified.

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/bicompartmental implants/osteotomies. 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 KRS (K142161)
• iTotal CR KRS (K152704)

Submission Summary (Full Text)

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March 25, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730

Re: K153721

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, OIY, OOG Dated: December 23, 2015 Received: December 28, 2015

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 [phone] or [phone] 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" (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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K153721

#### Device Name

ConforMIS iTotal Cruciate Retaining Knee Replacement System

Indications for Use (Describe)

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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
- · Post traumatic loss of joint function.
- · Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 6.0 510(K) SUMMARY (PAGE 1 OF 5)

| Submitter's Name<br>and Address: | ConforMIS, Inc.<br>28 Crosby Drive<br>Bedford, MA 01730 | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment<br>Registration<br>Number: | 3009844603 and 3004153240 | |
| Date of Summary: | December 21, 2015 | |
| Contact Person:<br>Telephone Number:<br>Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs<br>[phone]<br>[phone] | |
| Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) | |
| Common Name: | Total Cruciate Retaining Knee Replacement System | |
| Regulatory Status<br>and Regulation<br>Number: | Class II<br>21 CFR 888.3560 | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis | |
| Device<br>Classification: | Product Codes:<br>JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. | |
| | OOG: Knee Arthroplasty Implantation System.<br>Intended to be used to assist in the implantation of a specific knee<br>arthroplasty device or a set of specific knee arthroplasty devices.<br>Indicated to include guiding alignment, making or establishing cuts,<br>selecting, sizing, attaching, positioning or orienting implant<br>components. | |
| | OIY: Prosthesis, knee, patellofemorotibial, semi-constrained,<br>cemented polymer + additive/metal/polymer + additive. This generic<br>type of device includes prosthesis that have a femoral component<br>made of alloys, such as cobalt-chromium-molybdenum, and a tibial<br>component(s) and/or a retropatellar resurfacing component made of<br>ultra-high molecular weight polyethylene plus an additive, such as a-<br>tocopherol. | |

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### 510(K) SUMMARY (PAGE 2 OF 5)

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.

K142161, K152704

#### This implant is intended for cemented use only.

ldentification of the ConforMIS iTotal CR Knee Replacement System (ITOTAL CR Legally Marketed KRS) Device (Predicate Device Class: 11 Device): Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560

510(k) Number:

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#### 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 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, patient specific accessory orthopedic manual surgical instruments designed for use with the modified 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)s K142161 and K152704.

The subject of this premarket notification is substantially Substantial Equivalence: equivalent to the iTotal CR KRS (K142161 cleared November 14, 2014 and K152704 cleared October 21, 2015). The following testing was performed to establish substantial equivalence:

- Software verification and validation testing of proprietary . software

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# 510(K) SUMMARY (PAGE 4 OF 5)

# Description and Assessment of NonclinicalTesting:

The modified iTotal CR KRS and predicate iTotal CR KRS have the same technological characteristics. There have been no changes to the modified iTotal CR KRS device with respect to design, materials and methods of manufacture, packaging, or sterilization. The design of the device remains similar to that cleared in K142161 and K152704.

The proposed 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 1 below.

## Table 1: Comparison between the Modified and Predicate Device

| Characteristic | Predicate<br>iTotal Cruciate<br>Retaining Knee<br>Replacement System<br>(K142161 and K152704) | iTotal Cruciate<br>Retaining Knee<br>Replacement<br>System<br>(This submission) |
|------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| CAD Process for<br>Tibial implants | iTotalTib version 3.0 or<br>manual process | iFit iTotalTib CR<br>version 4.0 or<br>manual process |
| CAD Process for<br>Tibial iJigs | iTotal TibJigs version 2.0<br>or manual process | iFit iTotalTib CR<br>version 4.0 or<br>manual process |
| CAD Review of<br>tibial components | Manual Process | iFit iTotalTib CR<br>version 4.0 or<br>manual process |

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 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 iFit iTotalTib CR

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# 510(K) SUMMARY (PAGE 5 OF 5)

Conclusion 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 the intended use. Clinical data is not necessary to demonstrate substantial equivalence.

> Based on the testing conducted, it is concluded that the modified iTotal CR KRS is substantially equivalent to the predicate iTotal CR KRS (K142161 cleared November 14, 2014 and K152704 cleared October 21, 2015).