ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K103117 · Conformis, Inc. · JWH · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K103117
• Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Special
• 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 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 implant is intended for cemented use only.

Device Story

Patient-specific, tri-compartmental, posterior cruciate ligament (PCL) retaining knee replacement system. Inputs: patient CT or MR scans. Transformation: patient-specific implant design based on anatomical/geometric requirements. Output: femoral, tibial, and patellar components. Used in clinical settings by orthopedic surgeons for total knee arthroplasty. Bone-preserving design requires minimal resection. Benefits: improved fit through patient-specific geometry. Clinical decision-making: replaces damaged knee joint surfaces to alleviate pain and restore function.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical laboratory bench testing, including tibiofemoral contact area/stress, modular assembly/disassembly, and constraint testing.

Technological Characteristics

Materials: Cobalt chromium molybdenum (CoCrMo) alloy for femoral and tibial tray; UHMWPE for tibial inserts and patellar component. Design: Patient-specific, semi-constrained, cemented, fixed-bearing, PCL-retaining. Dimensions: Tibial inserts 6-16mm; Patellar sizes 32-41mm. Sterilization: Double-pouched Tyvek/film.

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 patients requiring non-cemented fixation.

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)

Submission Summary (Full Text)

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#### ConforMIS iTotal CR Knee Repair System

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JAN - 7 2011

#### 510(K) SUMMARY

This 510(k) Summary for the ConforMIS 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>2 Fourth Ave.<br>Burlington, MA 01804 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amita S. Shah, Director, Quality Assurance and Regulatory Affairs |
| Date: | October 20, 2010 |
| Name of Medical<br>Device: | Device Regulation: 21 CFR 888.3560 |
| | Product Code: JWH, Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis |
| | Common/Usual Name: Cruciate Retaining Total Knee Replacement<br>System |
| | Proprietary Name: ConforMIS iTotal Cruciate Retaining Knee<br>Replacement System |
| Device<br>Classification: | Class II |
| | In accordance with per 21 CFR 888.3560, a knee joint |
| | patellofemorotibial polymer/metal/polymer non-constrained cemented<br>prosthesis is classified by the FDA as a Class II Medical Device. |
| Indications for 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.<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 function and<br>stability.<br>• Failed osteotomies, hemiarthoplasties, and unicondylar, patello-<br>femoral or bi-compartmental implants.<br>The implant is intended for cemented use only. |

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ConforMIS iTotal CR Knee Repair System

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VID311

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| 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 design<br>incorporates a bone preserving approach with minimal bone resection of<br>the tibia and femur for the treatment of severe pain and/or disability of a<br>knee damaged by osteoarthritis or trauma.<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 of identical<br>configuration. The patellar component is manufactured from UHMWPE. |
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| 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 other currently marketed,<br>cemented total knee replacement systems. The following testing was<br>performed to establish substantial equivalence:<br>Tibiofemoral contact area/contact stress testing Modular assembly and disassembly testing of the tibial tray/insert Constraint testing The proposed iTotal CR KRS has the same technological characteristics<br>i.e. design, material intended use and function as the predicate iTotal<br>CR KRS (K094050) as outlined in the table below: |

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K103117

ConforMIS iTotal CR Knee Repair System

<103 117*3|12/06/10
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#### Comparison of the Modified iTotal CR KRS with the Predicate iTotal CR KR System Characteristic Modified iTotal CR KRS Predicate iTotal CR KRS (K094050) (This submission) Indication for Use The iTotal® CR Knee Replacement System is Same 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 bi-compartmental prosthesis. The indications for use include: o Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. o 0 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 Yes Intended for Cement Yes Use Only Components Same Femoral Component o o Metal Backed Tibial Component o Patellar Component Same Materials Femoral Implant- CoCrMo o o Metal-Backed Tibial Components: Tibial tray- CoCrMo o Tibial Insert-UHMWPE o Patellar Component: UHMWPE o Knee joint patellofemorotibial semi -Design Same constrained cemented prosthesis Configuration Same -Femoral Implant Constant coronal curvature o � Same o Femoral cuts o o Distal femoral cuts Anterior femoral cut 0 の、 Anterior femoral chamfer cut Posterior femoral cuts 0 Posterior femoral chamfer cuts o

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## K103117

## ConforMIS iTotal CR Knee Repair System

Image /page/3/Picture/2 description: The image contains handwritten text. The text "K1031174914" is prominently displayed in a bold, cursive style. Above this, the date "12/06/10" is written in a smaller font.

| -Tibial Implant | Configuration: Metal Backed Tibial Implant<br>Single or Dual inserts<br>Insert sizes:6-16mm<br>Articulating Surface:<br>Curved Profile: patient specific<br>Tray interlock:<br>Interference fit Anterior lip Tray undercut design | Same<br>Same<br>Same<br>Articulating surface:<br>Curved Profile: patient specific<br>Tray interlock:<br>Interference fit No Anterior lip Tray pocket design |
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| -Patellar Implant | Symmetrical, offered in sizes ranging from<br>32, 35, 38 and 41 mm, with corresponding<br>heights of 6, 7, 8.5 and 10 mm | Same |
| Principle of Operation | Cemented use<br>Fixed Bearing Design | Same |
| Posterior Cruciate<br>Ligament (PCL) Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| Packaging | Device components are individually double<br>pouched using Tyvek® /film pouches which are<br>sealed and labeled | Same |
| 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<br>equivalence. | |

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

ConforMIS. Inc. % Ms. Amita S. Shah Director, Quality Assurance and Regulatory Affairs 2 Fourth Avenue Burlington, Massachusetts 01804

JAN - 7 2011

Re: K103117

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/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH Dated: December 6, 2010 Received: December 8, 2010

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

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#### Page 2 - Ms. Amita S. Shah

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/CDRHQffices/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/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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## 6.0 INDICATION FOR USE STATEMENT

# 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 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 bicompartmental implants.

The implant is intended for cemented use only.

Prescription Use × (Part 21 CFR 801 Subpart D)

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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 Surgical, Orthopedic, and Restorative Devices

510(k) Number 163117