CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K113378 · Conformis, Inc. · JWH · Feb 15, 2012 · Orthopedic

Device Facts

• Record ID: K113378
• Device Name: CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 15, 2012
• 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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal CR KRS is intended for cemented use only.

Device Story

The iTotal CR KRS is a patient-specific, tricompartmental, posterior cruciate ligament (PCL) retaining knee replacement system. It consists of a femoral component (CoCrMo alloy), a metal-backed tibial tray (CoCrMo alloy) with UHMWPE inserts, and a UHMWPE patellar component. The device is designed using patient-specific imaging (CT or MR scans) processed through proprietary software to match individual anatomy. It is used by orthopedic surgeons in a clinical setting to treat severe knee pain and disability. The patient-specific design aims to preserve bone by minimizing resection. The system is implanted via cemented fixation. The output is a custom-fit prosthetic that restores joint function and stability, benefiting patients by addressing complex joint disease that cannot be treated by partial implants.

Clinical Evidence

No clinical data was required to demonstrate substantial equivalence. Evidence is based on non-clinical laboratory testing and software verification and validation of the proprietary design software.

Technological Characteristics

Patient-specific tricompartmental knee prosthesis. Materials: Cobalt chromium molybdenum (CoCrMo) alloy for femoral/tibial components; UHMWPE for tibial inserts and patellar component. Design: PCL-sparing, fixed-bearing, semi-constrained, cemented. Instrumentation: Patient-specific Nylon jigs. Software: SegSurf version 2.0 for patient-specific design based on CT/MR imaging.

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 partial/bi-compartmental implants. Suitable for moderate varus, valgus, or flexion deformities with stable ligamentous structures. Intended for cemented use only.

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)

Submission Summary (Full Text)

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K 113378 PAGE 1 OF 5

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#### 8.0 510(K) SUMMARY

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| Submitter's Name and<br>Address | ConforMIS Inc.<br>11 North Ave.<br>Burlington, MA 01803 |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number | 3004153240 |
| Date of Summary | November 14, 2011 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and<br>Regulatory Affairs<br>[phone]<br>[phone] |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or Usual<br>Name | Cruciate Retaining Total Knee Replacement<br>System |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| Indications for Use | The iTotal® CR Knee Replacement System (KRS) is intended<br>for use as a total knee replacement in patients with knee joint<br>pain and disability whose conditions cannot be solely<br>addressed by the use of a prosthetic device that treats only<br>one or two of the three knee compartments, such as a<br>unicondylar, patello-femoral or bi-compartmental prosthesis.<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 the<br>ligamentous structures can be returned to adequate<br>function and stability.<br>• Failed osteotomies, hemiarthoplasties, and unicondylar,<br>patello-femoral or bi-compartmental implants.<br>The iTotal CR KRS is intended for cemented use only. |
| Identification of the<br>Legally Marketed<br>Device<br>(Predicate Device) | ConforMIS iTotal CR Knee Replacement System (KRS)<br>Device Class: II<br>Product Code: JWH<br>Regulation Number: 21 CFR 888.3560<br>510(k) number: K094050, K103117 |
| Device<br>Description | The iTotal CR Knee Replacement System (hereafter referred to as<br>the "iTotal CR KRS") is a patient specific tricompartmental faceted<br>posterior cruciate ligament (PCL) retaining knee replacement<br>system. The iTotal CR KRS is a semi-constrained cemented knee<br>implant which consists of a femoral, tibial and patellar component.<br>The product design incorporates a bone preserving approach with<br>minimal bone resection of the tibia and femur for the treatment of<br>severe pain and/or disability of a knee damaged by osteoarthritis or<br>trauma. |
| | Using patient imaging (either CT or MR scans) and a combination<br>of proprietary and off the shelf software a patient-specific implant is<br>designed, that best meets the geometric and anatomic<br>requirements of the specific patient. The femoral component is<br>manufactured from cobalt chromium molybdenum ("CoCrMo")<br>alloy. The tibial component includes a metal tray manufactured<br>from CoCrMo alloy and either one or two polyethylene inserts<br>manufactured from UHMWPE of identical configuration. The<br>patellar component is manufactured from UHMWPE. |
| Substantial<br>Equivalence: | The product subject of this premarket notification is substantially<br>equivalent to the iTotal Cruciate Retaining Knee Replacement<br>System (K094050 cleared September 16, 2010 and K103117<br>cleared January 7, 2011). The following testing was performed to<br>establish substantial equivalence:<br>Software verification and validation testing of proprietary<br>software |

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#### 510(k) Summary continued

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### 510(k) Summary continued

#### Device Comparison

| | Predicate<br>iTotal CR Knee<br>Replacement System<br>K103117 | Predicate<br>iTotal CR Knee<br>Replacement System<br>K094050 | Modified Device<br>iTotal CR Knee<br>Replacement System |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Femoral<br>Component Tibial Implant Metal Backed Tibial<br>Component Patellar component | Femoral<br>Component Tibial Implant Metal Backed<br>Tibial Component Patellar component | Femoral<br>Component Tibial Implant Metal Backed<br>Tibial Component Patellar component |
| Materials | Femoral Implant:<br>CoCrMo Metal Backed Tibial<br>Components: Tibial tray:<br>CoCrMo Tibial<br>Inserts:<br>UHMWPE All Polymer Patellar<br>Component:<br>UHMWPE | Femoral Implant:<br>CoCrMo Metal Backed Tibial<br>Components: Tibial tray:<br>CoCrMo Tibial<br>Inserts:<br>UHMWPE All Polymer Patellar<br>Component:<br>UHMWPE | Femoral Implant:<br>CoCrMo Metal Backed Tibial<br>Components: Tibial tray:<br>CoCrMo Tibial<br>Inserts:<br>UHMWPE All Polymer Patellar<br>Component:<br>UHMWPE |
| Design | Knee joint<br>patellofemorotibial<br>semi-constrained<br>cemented prosthesis | Knee joint<br>patellofemorotibial<br>semi-constrained<br>cemented prosthesis | Knee joint<br>patellofemorotibial<br>semi-constrained<br>cemented prosthesis |
| Principle of<br>Operation | Cemented Use fixed<br>Bearing Design | Cemented Use fixed<br>Bearing Design | Cemented Use fixed<br>Bearing Design |
| Patient<br>Matched | Yes | Yes | Yes |
| Patellar<br>Design/<br>Dimensions | Symmetrical, offered in<br>various sizes | Symmetrical, offered in<br>various sizes | Symmetrical, offered in<br>various sizes |
| Minimum<br>Thickness of<br>Tibial Insert<br>(UHMWPE) | 6 mm | 6 mm | 6 mm |
| Posterior<br>Cruciate<br>Ligament<br>(PCL) Sparing | Yes | Yes | Yes |
| | Predicate<br>iTotal CR Knee<br>Replacement System<br>K103117 | Predicate<br>iTotal CR Knee<br>Replacement System<br>K094050 | Modified Device<br>iTotal CR Knee<br>Replacement System |
| Instrumentation<br>n | Patient specific Nylon<br>jigs | Patient specific Nylon<br>jigs | Patient specific Nylon<br>jigs |
| Software | SegSurf(T) version 1.1 | SegSurf(T) version 1.1 | SegSurf(T) version 2.0 |

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510(k) Summary continued

| 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>Detailed software description and software verification and<br>validation testing of proprietary software |
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| 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 intended use. Clinical data is not necessary to demonstrate<br>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 (K094050 cleared September 16, 2010<br>and K103117 cleared January 7, 2011). |

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

ConforMIS, Incorporated % Ms. Amita Shah, RAC Vice President, Quality Assurance and Regulatory Affairs l l North Avenue Burlington, Massachusetts 01803

FEB 15 2012

Re: K113378

Trade/Device Name: iTotal CR Knee Replacement System 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 Dated: November 14, 2011 Received: November 16, 2011

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.

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 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark A. Milliman

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

Enclosure

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#### Indications for Use

510(k) Number (if known): _if(33388

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, patello-femoral or bi-compartmental 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. o
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be t returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bio compartmental implants.

The iTotal CR KRS is intended for cemented use only.

Katherin V. Cheney

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113378

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)