CONFORMIS UNI-CONDYLAR KNEE SYSTEM

K072586 · Conformis, Inc. · HSX · Nov 8, 2007 · Orthopedic

Device Facts

• Record ID: K072586
• Device Name: CONFORMIS UNI-CONDYLAR KNEE SYSTEM
• Applicant: Conformis, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Nov 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ConforMIS Unicondylar Knee System is intended for use in patients with: - joint impairment due to osteoarthritis or . traumatic arthritis of the knee - . Previous tibial condyle or plateau fracture, creating loss of function - valgus or varus deformity of the knee . The ConforMIS Unicondylar Knee System is intended for use with cement.

Device Story

Patient-specific unicondylar knee replacement system (iUni); designed from patient CT or MR images to match unique anatomy; replaces one knee compartment. Device is unconstrained in anteroposterior and mediolateral directions; allows internal/external rotation; movement limited by patient's native ligaments and soft tissues. Used by orthopedic surgeons in clinical settings. Implants are custom-manufactured based on imaging data to restore normal joint function. Benefits include anatomical fit for patients requiring unicondylar arthroplasty.

Clinical Evidence

No clinical data; bench testing only. Design verification confirmed that implants designed from MRI data have the same physical parameters as those designed from CT scan data.

Technological Characteristics

Patient-specific metal/polymer non-constrained cemented prosthesis. Materials and manufacturing methods identical to predicate devices. Designed from CT or MR imaging data. Intended for cemented use.

Indications for Use

Indicated for patients with knee joint impairment due to osteoarthritis or traumatic arthritis, previous tibial condyle or plateau fracture with loss of function, or valgus/varus deformity. For use with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• ConforMIS Unicondylar Knee (K043570)
• ConforMIS Bicompartmental Knee (K053488)
• ConforMIS Total Knee (K0526876)

Submission Summary (Full Text)

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K 072586 # '1/3

# Summary of Safety and Effectiveness

| Submitted By: | ConforMIS, Inc.<br>2 Fourth Avenue<br>Burlington, MA 01803 | NOV 0 8 2007 |
|-------------------------------|------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | S. Michael Sharp, PhD<br>Sr. VP, Regulatory and Clinical Affairs | |
| Phone | 781.860.5111 | |
| FAX | 781.860.5108 | |
| Date: | September 14, 2007 | |
| Trade/Proprietary Name | Unicondylar Knee Repair System/<br>ConforMIS™ UCD | |
| Common Name | Unicondylar Knee System | |
| Reference/Classification Name | 21 CFR 888.3520 - Knee joint femorotibial<br>metal/polymer non-constrained cemented prosthesis | |

## Predicate Devices:

| Technological Characteristics | Indications for Use |
|------------------------------------------------------------------------------------|--------------------------------------------|
| • ConforMIS Bicompartmental Knee<br>(K053488)<br>• ConforMIS Total Knee (K0526876) | • ConforMIS Unicondylar Knee<br>(K 043570) |

Intended Use:

The ConforMIS Unicondylar Knee System is intended for use in patients with:

- joint impairment due to osteoarthritis or . traumatic arthritis of the knee
- . Previous tibial condyle or plateau fracture, creating loss of function
- valgus or varus deformity of the knee .

The ConforMIS Unicondylar Knee System is intended for use with cement.

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### Use of the Term "Substantial Equivalence"

The term "Substantial Equivalence" is used in this submission within the confines of its statutory use in the FDA's evaluation of a Pre-Market Notification Submission. Any statement regarding Substantial Equivalence used in this submission relates only to whether the device that is the subject of this submission may be lawfully marketed in the United States without pre-market approval or reclassification, and should not be interpreted as an admission, or any kind or type of evidence, in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office.

The present submission and statements therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in the submission, or its use, may be considered indistinct, from a patentability perspective, from any other device referred to in this sub mission.

| Device Description | The ConforMIS Unicondylar Knee System ("iUni")<br>is a device developed from patient CT scans or MR<br>images to replace one compartment of the knee<br>condyles. It is unconstrained in the anteroposterior<br>and mediolateral directions and allows<br>internal/external rotation between the femoral and<br>tibial components. Movement is limited by the<br>ligaments and other soft tissues surrounding the<br>device. The device is designed to match the<br>patient's unique normal anatomy. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicates: | The ConforMIS Unicondylar Knee System ("iUni")<br>designed from MR images is substantially equivalent<br>to the ConforMIS Unicondylar Knee System<br>designed from CT Scan data, in technological<br>characteristics in terms of design method, design<br>characteristics and production process, as well as<br>materials and indications. It is substantially<br>equivalent to the ConforMIS Bi-Condylar Knee<br>System and the ConforMIS total knee system in<br>terms of design method, materials and manufacturing<br>methods. All are intended for cemented use only. |
| Performance Data | Non-clinical Performance and Conclusions:<br>The design verification procedure for the ConforMIS<br>Unicondylar Knee System ("iUni") found that<br>implants designed using MRI data to have the same<br>physical parameters as those for the same patient<br>designed from CT scan data. As all implants are<br>made of the same materials, using identical<br>manufacturing methods, it was concluded that |

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K072586 # 3/3

implants designed from MR images would be aas safe and effective as the predicate device, the previously cleared version of the implant designed based on CT scan data. 1

Clinical Performance:

Clinical data and conclusions are not necessary to demonstrate substantial equivalence

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 8 2007

NOV 0 8 2007

ConforMIS, Inc. % S. Michael Sharp, Ph.D. Sr. Vice President, Regulatory and Clinical 2 Fourth Avenue Burlington, Massachusetts 01803

K072586 Re: Trade/Device Name: ConforMIS Uni-Condylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: September 12, 2007 Received: September 13, 2007

Dear Dr. Sharp:

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 such 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); 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.

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Page 2 – S. Michael Sharp, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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# Indications for Use

510(k) Number (if known): K072586

Device Name: ConforMISTM, Inc. Uni-condylar Knee Repair System

Indications for Use:

The ConforMIS unicondylar implant is intended for use in patients with:

- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous tibial condyle or plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .

The ConforMIS unicondylar implant is for use with bone cement

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K072546
(Posted November 13, 2003)