ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K131467 · Conformis, Inc. · JWH · Jul 18, 2013 · Orthopedic

Device Facts

• Record ID: K131467
• Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 18, 2013
• 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 Knee Replacement System is a patient-specific, tricompartmental, posterior cruciate ligament (PCL) retaining knee prosthesis. It consists of a femoral component, a metal-backed tibial tray with polyethylene inserts, and a patellar component. The device is designed using patient-specific CT or MR imaging data processed through proprietary software to create implants matching the patient's unique anatomy. The femoral component is cobalt-chromium-molybdenum (CoCrMo) alloy; tibial and patellar components use UHMWPE or highly cross-linked Vitamin E infused polyethylene (iPoly XE). The system includes patient-specific manual surgical instruments (nylon jigs) to assist in bone cutting and component positioning. Used in clinical settings by orthopedic surgeons, the system is implanted via cementation. The patient-specific design aims to improve fit and restore joint function. This modification adds a 29mm patella size and provides instructions for intra-operative steam sterilization of components.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was demonstrated through non-clinical bench testing, including patella fixation testing and steam sterilization validation.

Technological Characteristics

Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE or iPoly XE (inserts/patella). Design: Patient-specific, tricompartmental, PCL-retaining, semi-constrained, cemented, fixed-bearing. Instrumentation: Patient-specific nylon jigs. Sterilization: VHP Gas Plasma (primary) and steam sterilization (intra-operative).

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, or failed prior knee implants (osteotomies, hemiarthroplasties, or partial replacements). Suitable for patients with moderate varus, valgus, or flexion deformity where ligamentous stability can be restored. Contraindicated for patients where anatomic landmarks for implant positioning cannot be identified 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

• ConforMIS iTotal CR Knee Replacement System (K122870)

Submission Summary (Full Text)

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## 8.0 510(K) SUMMARY

JUL 1 8 2013

| Submitter's Name<br>and Address | ConforMIS Inc.<br>28 Crosby Drive<br>Bedford, MA 01730 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number | 3009844603 |
| Date of Summary | July 17, 2013 |
| Contact Person | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number | [phone] |
| Fax Number | [phone] |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (iTotal CR<br>KRS) |
| Common or Usual<br>Name | Cruciate Retaining Total Knee Replacement System |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |

Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella

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## 510(K) Summary Continued

| Device Classification | Product Code:<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<br>generic type of device includes prosthesis that have a femoral<br>component made of alloys, such as cobalt-chromium-molybdenum,<br>and a tibial component(s) and/or a retropatellar resurfacing<br>component made of ultra-high molecular weight<br>polyethylene plus an additive, such as a-tocopherol. |
| Indications for Use | The iTotal CR Knee Replacement System (KRS) is intended for<br>use as a total knee replacement in patients with knee joint pain<br>and disability whose conditions cannot be solely addressed by the<br>use of a prosthetic device that treats only one or two of the three<br>knee compartments, such as a unicondylar, patellofemoral or<br>bicompartmental prosthesis.<br><br>The Indications for Use include:<br>• Painful joint disease due to osteoarthritis, traumatic<br>arthritis, rheumatoid arthritis or osteonecrosis of the knee.<br>• Post traumatic loss of joint function.<br>• Moderate varus, valgus or flexion deformity in which<br>the ligamentous structures can be returned to<br>adequate function and stability.<br>• Failed osteotomies, hemiarthroplasties, and<br>unicondylar, patellofemoral or bicompartmental<br>implants.<br>• Revision procedures provided that anatomic<br>landmarks necessary for alignment and positioning of<br>the implant are identifiable on patient imaging scans.<br><br>This implant is intended for cemented use only. |

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### 510(K) SUMMARY CONTINUED

| Identification of the Legally Marketed Device<br>(Predicate Device) | ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) |
|---------------------------------------------------------------------|-------------------------------------------------------------|
| Device Class: | II |
| Product Code: | JWH, OOG, OIY |
| Regulation Number: | 21 CFR 888.3560 |
| 510(k) number: | K122870 |

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 indudes 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 marking of bone before cutting.

The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510(k) K122870.

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#### 510(K) SUMMARY CONTINUED

Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K122870 cleared January 14, 2013). The following testing was performed to establish substantial equivalence:

- Patella Fixation Testing -
- Steam Sterilization Validation and Product Performance for Metal Implants and iJig Instrumentation post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.

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## 510(k) Summary continued

#### Device Comparison

| Attribute | Predicate<br>iTotal CR Knee Replacement<br>System<br>(K122870) | Modified Device<br>iTotal CR Knee Replacement<br>System<br>(This submission) | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Components | Femoral Component Tibial Implant Metal Backed Tibial Component Patellar component | Femoral Component Tibial Implant Metal Backed Tibial Component Patellar component | |
| Materials | Femoral Implant: CoCrMo Metal Backed Tibial<br>Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE<br>or iPoly XE All Polymer Patellar Component:<br>UHMWPE or iPoly XE | Femoral Implant: CoCrMo Metal Backed Tibial<br>Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE<br>or iPoly XE All Polymer Patellar Component:<br>UHMWPE or iPoly XE | |
| Design | Knee joint patellofemorotibial semi-<br>constrained cemented prosthesis | Knee joint patellofemorotibial semi-<br>constrained cemented prosthesis | |
| Principle of<br>Operation | Cemented Use Fixed Bearing<br>Design | Cemented Use Fixed Bearing Design | |
| Attribute | Predicate<br>iTotal CR Knee Replacement<br>System<br>(K122870) | Modified Device<br>iTotal CR Knee Replacement<br>System<br>(This submission) | |
| Indications for<br>Use | The iTotal CR Knee Replacement<br>System (KRS) is intended for use as<br>a total knee replacement in patients<br>with knee joint pain and disability<br>whose conditions cannot be solely<br>addressed by the use of a prosthetic<br>device that treats only one or two of<br>the three knee compartments, such<br>as a unicondylar, patellofemoral or<br>bicompartmental prosthesis.<br>The Indications for Use include:<br>• Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or<br>osteonecrosis of the knee.<br>• Post traumatic loss of joint<br>function.<br>• Moderate varus, valgus or<br>flexion deformity in which the<br>ligamentous structures can be<br>returned to adequate function<br>and stability.<br>• Failed osteotomies,<br>hemiarthroplasties, and<br>unicondylar, patellofemoral or<br>bicompartmental implants.<br>• Revision procedures provided<br>that anatomic landmarks<br>necessary for alignment and<br>positioning of the implant are<br>identifiable on patient imaging<br>scans.<br>This implant is intended for<br>cemented use only. | The iTotal CR Knee Replacement<br>System (KRS) is intended for use as<br>a total knee replacement in patients<br>with knee joint pain and disability<br>whose conditions cannot be solely<br>addressed by the use of a prosthetic<br>device that treats only one or two of<br>the three knee compartments, such<br>as a unicondylar, patellofemoral or<br>bicompartmental prosthesis..<br>The Indications for Use include:<br>• Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or<br>osteonecrosis of the knee.<br>• Post traumatic loss of joint<br>function.<br>• Moderate varus, valgus or<br>flexion deformity in which the<br>ligamentous structures can be<br>returned to adequate function<br>and stability.<br>• Failed osteotomies,<br>hemiarthroplasties, and<br>unicondylar, patellofemoral or<br>bicompartmental implants.<br>• Revision procedures provided<br>that anatomic landmarks<br>necessary for alignment and<br>positioning of the implant are<br>identifiable on patient imaging<br>scans.<br>This implant is intended for<br>cemented use only. | |
| Patient Matched | Yes | Yes | |
| Attribute | Predicate<br>iTotal CR Knee Replacement<br>System<br>(K122870) | Modified Device<br>iTotal CR Knee Replacement<br>System<br>(This submission) | |
| Tibial Implant | Configuration: Metal Backed<br>Tibial ImplantTibial Insert - UHMWPE or<br>iPoly XESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific | Configuration: Metal Backed<br>Tibial ImplantTibial Insert - UHMWPE or iPoly<br>XESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific | |
| Posterior<br>Cruciate<br>Ligament (PCL)<br>Sparing | Yes | Yes | |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | |
| Packaging | Device components are individually<br>double-pouched using Tyvek®/film<br>pouches which are sealed and<br>labeled | Device components are individually<br>double-pouched using Tyvek®/film<br>pouches which are sealed and<br>labeled | |
| Sterility Method/<br>Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 | |
| Instructions for<br>Intra-Operative<br>Sterilization | None | Steam Sterilization (SAL of 1x10-6) | |
| Initial Shelf-Life | 6 months | 6 months | |
| Labeled Non-<br>pyrogenic | No | No | |
| Patella Design<br>and Sizes<br>(diameter) | Symmetrical, offered in sizes: 32mm,<br>35mm, 38mm, 41mm, 44mm | Symmetrical, offered in sizes, 29mm,<br>32mm, 35mm, 38mm, 41mm, 44mm | |
| Description and<br>Conclusion of<br>Testing | Nonclinical Testing: The determination of substantial equivalence<br>for this device was based on a detailed device description. The<br>following non-clinical laboratory testing was performed<br>demonstrating that the device is safe and can be considered<br>substantially equivalent to the predicate device for the intended<br>use:<br>• Patella fixation testing<br>• Steam Sterilization Validation and Product Performance<br>post steam sterilization to support instructions provided for<br>sterilization of components in case of a loss of sterility. | | |
| Safety and<br>Performance | The determination of substantial equivalence for this device was<br>based on a detailed device description. Non-clinical laboratory<br>testing was performed demonstrating that the device is safe and<br>can be considered substantially equivalent to the predicate device<br>for the proposed intended use. Clinical data is not necessary to<br>demonstrate substantial equivalence. | | |
| Conclusion | Based on the testing conducted it is concluded that the modified<br>device is substantially equivalent to the iTotal Cruciate Retaining<br>Knee Replacement System K122870 cleared January 14, 2013. | | |

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Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella

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Public Health Service

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

July 18, 2013

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

Re: K131467

Trade/Device Name: iTotal® CR Knee Replacement System (KRS) 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: May 31, 2013 Received: June 4, 2013

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

Image /page/8/Picture/11 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address "

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

Sincerely yours,

# Erin I. Keith

For

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): K131467

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.

| Prescription Use | X |
|-----------------------------|---|
| (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)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131467

Special 510(k) - Modified ITotal® CR Knee Replacement System - 29mm Patella