UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD

K043570 · Conformis, Inc. · HSX · Mar 14, 2005 · Orthopedic

Device Facts

• Record ID: K043570
• Device Name: UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
• Applicant: Conformis, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Mar 14, 2005
• 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 for use with cement.

Device Story

Patient-specific unicondylar knee prosthesis; designed from patient CT scans to replace one compartment of knee condyles. Device is unconstrained in anteroposterior and mediolateral directions; allows internal/external rotation; movement limited by patient's native ligaments and soft tissues. Intended for cemented use. Used by orthopedic surgeons to restore knee function in patients with joint impairment or deformity. Benefits include anatomical conformity based on patient-specific imaging.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through design verification and non-clinical performance testing.

Technological Characteristics

Metal/polymer non-constrained cemented prosthesis. Patient-specific geometry derived from CT scans. Unconstrained design allowing internal/external rotation. Materials and design consistent with predicate knee systems.

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 knee 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

• ConforMIST™ IPD Knee Interpositional (K033242)
• Zimmer Unicompartmental Knee System (K033363)
• EIUS Unicompartmental Knee System (K033769)

Reference Devices

• Repicci II Unicondylar Knee

Submission Summary (Full Text)

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K04357-0

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## SECTION 2

1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of the 510(k) premarket notification for the ConforMIS, Inc. Unicondylar Knee Repair System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

MAR 1 4 2005

CONFIDENTIAL

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# Summary of Safety and Effectiveness

| Submitted By: | ConforMIS, Inc.<br>323 C Vintage Park Drive<br>Foster City, CA 94404<br>Phone [phone] |
|---------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Phone<br>FAX | Lyndall Erb, PhD<br>Director, Regulatory/Clinical & Quality Assurance<br>650-286-4166<br>650-286-4160 |
| Date: | December 22, 2004 |
| Trade/Proprietary Name | Unicondylar Knee Repair System/<br>ConforMISTM 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 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| • ConforMIST™ IPD Knee Interpositional<br>(K033242) | • Zimmer Unicompartmental Knee System<br>(K033363)<br>• EIUS Unicompartmental Knee System<br>(K033769) |

The ConforMIS™ Unicondylar Knee System is intended Intended Use: 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 for use with cement.

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| Device Description | The ConforMIS Unicondylar Knee System is a device<br>developed from patient CT scans to replace one<br>compartment of the knee condyles. It is unconstrained<br>in the anteroposterior and mediolateral directions and<br>allows internal/external rotation between the femoral<br>and tibial components. Movement is limited by the<br>ligaments and other soft tissues surrounding the device.<br>The device is designed to conform to the patient's<br>anatomy as closely as possible based on the CT scans. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Devices: | The ConforMIS Unicondylar Knee System is<br>substantially equivalent to the ConforMIS IPD in<br>technological characteristics in terms of design and<br>production process, as well as materials and indications.<br>It is substantially equivalent to the Zimmer<br>Unicompartmental Knee System and the Repicci II<br>Unicondylar Knee in that all have similar indications,<br>design, materials and mechanical safety. All are<br>intended for cemented use only. |
| Performance Data | Non-clinical Performance and Conclusions:<br>Testing completed as part of the design verification<br>procedure for the ConforMIS Unicondylar Knee System<br>found this device to be as safe and effective as the<br>predicate devices, further confirming substantial<br>equivalence.<br>Clinical Performance:<br>Clinical data and conclusions are not necessary to<br>demonstrate substantial equivalence. |

·

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

MAR 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lyndall Erb, Ph.D. Director, Regulatory/Clinical Affairs & Quality Assurance ConforMIS., Inc. 323 C Vintage Park Drive Foster City, California 94404

Re: K043570

Trade/Device Name: ConforMIS™ Unicondylar Knee Repair System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 18, 2005 Received: February 22, 2005

Dear Dr. Erb:

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 – Lyndall Erb, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I fills letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification. The I Dri mang of baction for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad rios for your (240) 276-__. Also, please note the regulation entitled, Colliation of Compliance at (210) 210-210-2007 (21CFR Part 807.97). You may obtain Misoranung of Telerence to premainters inibilities under the Act from the Division of Small other general information on Jour respenses Assistance at its toll-free number [phone] or jvaliulacturers, International und Constal.http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

O mark X Millican

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K043570

Device Name: ConforMIS™ Unicondylar Knee Repair System

Indications for Use:

The ConforMIS™ unicondylar implant is intendcd for use in patients with:

- ontoriVIS™ unicondyial implant is incentration anthritis of the knee
joint impairment due to osteoarthritis or traver ation loca of function o
- joint impairment due to osteourings of cacture, creating loss of function .
- valgus or varus deformity of the knee e

The ConforMIS™ unicondylar implant is for use with bone cement.

Mark n Millican

Vegarotive Division of and Neurological De Carlis

**510(k) Number** K043570

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
) (PLEASE DO NOT WRITEDED) OF NEEDED)

CONFIDENTIAL