iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System

K152704 · Conformis, Inc. · JWH · Oct 21, 2015 · Orthopedic

Device Facts

• Record ID: K152704
• Device Name: iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 21, 2015
• Decision: SESE
• Submission Type: Special
• 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. The iTotal PS 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, polyarthritis, or osteonecrosis of the knee - Post traumatic loss of joint function - Moderate varus, valgus, or flexion deformity - 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 knee replacement system; includes femoral, tibial, and patellar components. Uses patient imaging and proprietary/off-the-shelf software to design implants matching patient-specific geometric/anatomic requirements. Femoral component: CoCrMo alloy. Tibial tray: CoCrMo alloy. Inserts/patellar components: UHMWPE or Vitamin E infused highly cross-linked polyethylene (iPoly XE). Used in clinical settings by surgeons for total knee arthroplasty. Includes patient-specific manual surgical instruments (iJig) for intra-operative positioning and bone cutting. Modification allows iJig instruments to be provided non-sterile for end-user steam sterilization. Output is a customized implant system to restore joint function and stability. Benefits include improved fit and alignment based on patient anatomy.

Clinical Evidence

Bench testing only. Validation performed for steam sterilization of iJig instruments to an SAL of 1x10^-6 and post-sterilization product integrity testing. No clinical data required for substantial equivalence.

Technological Characteristics

Patient-specific tricompartmental knee prosthesis. Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE or Vitamin E infused highly cross-linked polyethylene (inserts/patellar). Semi-constrained, cemented. Includes patient-specific manual surgical instruments (iJig). Sterilization: Implants provided sterile (VHP/EO); instruments provided sterile (VHP/EO) or non-sterile for end-user steam sterilization.

Indications for Use

Indicated for patients with knee joint pain and disability requiring total knee replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis, or osteonecrosis; post-traumatic loss of joint function; moderate varus, valgus, or flexion deformity; or failed previous implants (osteotomies, hemiarthroplasties, unicondylar, patellofemoral, or bicompartmental).

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 (K142161)
• ConforMIS iTotal CR Knee Replacement System (K142404)
• ConforMIS iTotal PS Knee Replacement System (K142161)
• ConforMIS iTotal PS Knee Replacement System (K142404)

Reference Devices

• Signature Patient-Specific Surgical Guides (K140257)
• Visionaire (K143226)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.

October 21, 2015

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: K152704

Trade/Device Name: ConforMIS iTotal Cruciate Retaining Knee Replacement System, ConforMIS iTotal Posterior Stabilized 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: September 18, 2015 Received: September 21, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Amita Shah

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [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)

K152704

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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 [e-mail]

"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."

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## Indications for Use

510(k) Number (if known)

#### K152704

Device Name

ConforMIS iTotal Posterior Stabilized Knee Replacement System

Indications for Use (Describe)

The iTotal PS 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, polyarthritis, or osteonecrosis of the knee

· Post traumatic loss of joint function

· Moderate varus, valgus, or flexion deformity

· 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)

#### 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 [e-mail]

"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."

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## 8.0 510(K) SUMMARY (PAGE 1 OF 4)

| Submitter's Name and<br>Address: | ConforMIS, Inc.<br>28 Crosby Drive<br>Bedford, MA 01730 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3009844603 and 3001153240 |
| Date of Summary: | September 18, 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(s): | ConforMIS iTotal® Cruciate Retaining Knee Replacement System<br>(iTotal CR KRS)<br>ConforMIS iTotal® Posterior Stabilized Knee Replacement System<br>(iTotal PS KRS) |
| Common Name(s): | Total Cruciate Retaining Knee Replacement System<br>Total Posterior Stabilized Knee Replacement System |
| Regulatory Status and<br>Regulation Number: | Class II<br>21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| Device 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 components. |
| | OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,<br>polymer + additive/metal/polymer + additive. This generic type of device<br>includes prosthesis that have a femoral component made of alloys, such<br>as cobalt-chromium-molybdenum, and a tibial component(s) and/or a<br>retropatellar resurfacing component made of ultra-high molecular weight<br>polyethylene plus an additive, such as α-tocopherol. |

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## 510(K) SUMMARY (PAGE 2 OF 4)

Indications for Use:

#### iTotal CR KRS

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.

### iTotal PS KRS

The iTotal PS 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, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- 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.

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## 510(K) SUMMARY (PAGE 3 OF 4)

| Identification of the Legally Marketed Device(s) (Predicate Device(s)): | ConforMIS iTotal CR Knee Replacement System |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Class: II |
| | Product Code: JWH, OOG, OIΥ |
| | Regulation Number: 21 CFR 888.3560 |
| | 510(k) Number: K142161 and K142404 |
| | ConforMIS iTotal PS Knee Replacement System |
| | Device Class: II |
| | Product Code: JWH, OOG, OIΥ |
| | Regulation Number: 21 CFR 888.3560 |
| | 510(k) Number: K142161 and K142404 |
| Device Description: | The iTotal® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components. |
| | 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 single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, 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 KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile and for single-use only. The purpose of this submission to propose the alternative option to provide these single-use, disposable iTotal iJig instruments non-sterile to be steam sterilized by the end-user. 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 K142161 and K142404. |

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

Comparison Summary of Technological Characteristics and Modifications Proposed:

The modified iTotal KRS and predicate iTotal KRS have the same technological characteristics. There have been no changes to the modified iTotal KRS devices with respect to the intended use and function. The design, materials, and methods of manufacture and packaging remain similar to those cleared via K142161 and K142404.

This submission proposes an alternative option to provide the iTotal iJiq instrumentation as non-sterile to be steam sterilized by the end-user. The implants will continue to be provided sterile as currently cleared (K142161 and K142404).

| Devices | | |
|---------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| How Supplied | iTotal Implants | iTotal iJig<br>Instrumentation |
| Predicate Devices<br>(K142161 &<br>K142404) | Provided sterile via<br>VHP (gas glasma) or<br>EO to an SAL of 1x10-6 | Provided sterile via<br>VHP (gas glasma) or<br>EO to an SAL of 1x10-6 |
| This Submission | Provided sterile via<br>VHP (gas glasma) or<br>EO to an SAL of 1x10-6 | Provided sterile via<br>VHP (gas glasma) or<br>EO to an SAL of 1x10-6<br>OR<br>Provided non-sterile to<br>be steam sterilized by<br>the end-user* |

# Table 8.0-1: Comparison Between the Predicate and Modified

*The following currently marketed systems provide non-sterile, patient-specific instruments:

- Signature Patient-Specific Surgical Guides (K140257)
- Visionaire (K143226) ●

Substantial Equivalence: The products subject of this premarket notification are substantially equivalent to the iTotal CR and PS KRS (K142161, cleared November 14, 2014 and K142404, cleared December 11, 2014). The following testing was performed to establish substantial equivalence:

- . Steam Sterilization Validation to a Sterility Assurance Level (SAL) of 1x10-6
- Product Integrity Testing Post-Steam Sterilization ●

Conclusion: The determination of substantial equivalence for these devices was based on detailed device descriptions. Non-clinical laboratory testing was performed demonstrating that the devices can be considered substantially equivalent to the predicate devices for the intended uses. Clinical data is not necessary to demonstrate substantial equivalence.

> Based on the testing conducted, it is concluded that the modified iTotal KRS are substantially equivalent to the predicate iTotal KRS (K142161, cleared November 14, 2014 and K142404, cleared December 11, 2014).