CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K112780 · Conformis, Inc. · JWH · Dec 15, 2011 · Orthopedic

Device Facts

• Record ID: K112780
• Device Name: CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iTotal® CR Knee Replacement System 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 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 implant is intended for cemented use only.

Device Story

Patient-specific tri-compartmental posterior cruciate ligament (PCL) retaining knee replacement system; designed for bone preservation. Inputs: patient CT or MR imaging data. Transformation: proprietary software uses imaging to design patient-specific femoral, tibial, and patellar components matching individual anatomy/geometry. Output: custom-fit cemented knee implant components. Used in clinical setting by orthopedic surgeons; provides natural kinematics by maintaining patient-specific femoral curves, offset, and joint lines. Benefits: improved fit and bone preservation compared to off-the-shelf implants.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical laboratory testing, including patello-femoral lateral subluxation testing, femoral fatigue testing, software validation, and cadaveric testing.

Technological Characteristics

Materials: Cobalt chromium molybdenum (CoCrMo) alloy for femoral/tibial components; UHMWPE for tibial/patellar inserts. Design: Patient-specific, tri-compartmental, PCL-retaining, semi-constrained, cemented. Connectivity: N/A. Sterilization: Not specified. Software: Proprietary design software for patient-specific geometry.

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, moderate varus/valgus/flexion deformity, or failed prior partial knee procedures. Contraindicated for conditions treatable by unicondylar, patello-femoral, or bi-compartmental prostheses.

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

• iTotal Cruciate Retaining Knee Replacement System (K094050)
• iTotal Cruciate Retaining Knee Replacement System (K103117)

Submission Summary (Full Text)

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K 1127.82(1|3)

## 7.0 510(k) SUMMARY

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Page 1 of 3

This 510(k) Summary for the ConforMS iTotal® Cruciate Retaining (CR) Knee Replacement System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name<br>and Address: | ConforMIS Inc.<br>11 North Ave.<br>Burlington, MA 01804 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amita S. Shah, Vice President, Quality Assurance and Regulatory<br>Affairs |
| Date: | September 23, 2011 |
| Name of Medical<br>Device: | Device Regulation: 21 CFR 888.3560<br>Product Code:<br>JWH, Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis<br>OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis.<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.<br>Common/Usual Name: Cruciate Retaining Total Knee Replacement<br>System<br>Proprietary Name: ConforMIS iTotal Cruciate Retaining Knee<br>Replacement System |
| Device<br>Classification: | Class II<br>In accordance with per 21 CFR 888.3560, a knee joint<br>patellofemorotibial polymer/metal/polymer non-constrained cemented<br>prosthesis is classified by the FDA as a Class II Medical Device. |

:

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K112780(2/3)

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## 510(k) SUMMARY Page 2 of 3

| Indications for<br>Use: | The iTotal® CR Knee Replacement System is intended for use as a total<br>knee replacement in patients with knee joint pain and disability whose<br>conditions cannot be solely addressed by the use of a prosthetic device<br>that treats only one or two of the three knee compartments, such as a<br>unicondylar, patello-femoral or bi-compartmental prosthesis. The<br>indications for use include:<br>Painful joint disease due to osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity in which the<br>ligamentous structures can be returned to adequate function and<br>stability. Failed osteotomies, hemiarthoplasties, and unicondylar, patello-<br>femoral or bi-compartmental implants. The implant is intended for cemented use only. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | The proposed iTotal CR Knee Replacement System (hereafter referred<br>to as the "iTotal CR KRS") is a patient specific tri-compartmental faceted<br>posterior cruciate ligament (PCL) retaining knee replacement system.<br>The iTotal CR KRS is a semi-constrained cemented knee implant which<br>consists of a femoral, tibial and patellar component. The product is<br>designed for bone preservation, with minimal bone resection of the tibia<br>and femur for the treatment of severe pain and/or disability of a knee<br>damaged by osteoarthritis or trauma. The joint restoring design provides<br>for more natural kinematics by maintaining the patient specific femoral<br>sagittal curves, preserving the patient specific femoral offset, preserving<br>the medial and lateral joint lines and having a patient specific fit.<br><br>Using patient imaging (either CT or MR scans), a patient-specific implant<br>is designed that best meets the geometric and anatomic requirements of<br>the specific patient. The device is manufactured from cobalt chromium<br>molybdenum ("CoCrMo") alloy. The tibial component includes a metal<br>tray manufactured from CoCrMo alloy and either one or two<br>polyethylene inserts manufactured from UHMWPE. The patellar |

component is manufactured from UHMVPE.

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### 510(k) SUMMARY Page 3 of 3

| Substantial<br>Equivalence: | The product subject of this premarket notification is substantially<br>equivalent to the iTotal Cruciate Retaining Knee Replacement System<br>(K094050 cleared September 16, 2010 and K103117 cleared January 7,<br>2011) and other currently marketed, cemented total knee replacement<br>systems. The following testing was performed to establish substantial<br>equivalence:<br>• Patello femoral lateral subluxation testing<br>• Femoral fatigue testing<br>• Software validation testing of proprietary software<br>• Cadaveric testing |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance: | The determination of substantial equivalence for this device was based<br>on a detailed device description. Non-clinical laboratory testing was<br>performed demonstrating that the device is safe and can be considered<br>substantially equivalent to the predicate device for the proposed<br>intended use. Clinical data is 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 consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

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

DEC 1 5 2011

ConforMIS Incorporated % Ms. Amita S. Shah Vice President, Quality Assurance and Regulatory Affairs 11 North Avenue Burlington. Massachusetts 01804

Re: K112780

Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH Dated: September 23, 2011 Received: September 27, 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. 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

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Page 2 - Ms. Amita S. Shah

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 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 yours,

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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# 112780 (1/1)

## 6.0 INDICATION FOR USE STATEMENT

112780

510(k) Number (if known):

Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

#### Indications for Use:

The iTotal® CR Knee Replacement System 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 compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The Indications for Use include:

- 0 Painful ioint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function. 0
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be g returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-0 compartmental implants.

The implant is intended for cemented use only.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter G. Allen. Res. MXM

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

KII2780
Number