ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

K140833 · Conformis, Inc. · JWH · Jun 30, 2014 · Orthopedic

Device Facts

• Record ID: K140833
• Device Name: ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iTotal PS 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, patellofemoral or bicompartmental prosthesis. The Indications for Use include: - Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. - Post traumatic loss of joint function. - Moderate varus, valgus or flexion deformity. - Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. - Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans This implant is intended for cemented use only.

Device Story

Patient-specific, tricompartmental, cruciate-sacrificing, semi-constrained cemented knee replacement system. Input: patient CT scan data. Process: proprietary and off-the-shelf software designs patient-specific femoral, tibial, and patellar components to match patient anatomy. Output: custom-manufactured CoCrMo femoral/tibial components and UHMWPE/Vitamin E-infused polyethylene inserts/patellar components. Used in clinical settings by orthopedic surgeons for total knee arthroplasty. Includes single-use, patient-specific ancillary surgical instruments (jigs, spacers, trials) to guide bone cuts and component positioning. Benefits: improved anatomical fit and alignment compared to off-the-shelf implants; assists surgeons in complex cases including revisions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical laboratory testing: femoral/tibial fatigue, contact area/surface stress, lateral stability, constraint analysis, rotational laxity, range of motion, interlock strength, push-in/push-out testing, cadaveric evaluation, software V&V, and MR compatibility.

Technological Characteristics

Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE or Vitamin E-infused UHMWPE (insert/patellar). Design: Patient-specific, semi-constrained, cemented. Ancillary instruments: Single-use, sterile, patient-specific guides. Software: Proprietary design software for patient-specific geometry. Sterilization: Ancillary instruments provided sterile.

Indications for Use

Indicated for patients with knee joint pain and disability requiring total knee replacement due to osteoarthritis, traumatic/rheumatoid arthritis, polyarthritis, osteonecrosis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, or failed prior partial/bicompartmental implants/osteotomies. Suitable for revision procedures if anatomic landmarks are identifiable via imaging. Contraindicated for patients requiring non-cemented fixation or where collateral ligaments are not intact.

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 (K131467, K131019)
• DePuy Attune Knee System (K111433)
• Zimmer Persona Personalized Knee System (K113369)

Submission Summary (Full Text)

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K140833

# 6.0 510(K) SUMMARY (PAGE 1 OF 5)

# JUN 3 0 2014

| Submitter's Name and<br>Address: | ConforMIS, Inc.<br>28 Crosby Drive<br>Bedford, MA 01730 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3009844603 and 3004153240 |
| Date of Summary: | March 31, 2014 |
| Contact Person:<br>Telephone Number:<br>Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs<br>[phone]<br>[phone] |
| Name of the Device: | ConforMIS iTotal <span>®</span> Posterior Stabilized Knee Replacement System<br>(iTotal PS KRS) |
| Common Name: | Posterior Stabilized Total Knee Replacement System |
| Regulatory Status and<br>Regulation Number: | Class II<br>21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| Device Classification: | Product Code:<br>JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. |
| | OOG: Knee Arthroplasty Implantation System.<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<br>components. |
| | OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,<br>polymer + additive/metal/polymer + additive.<br>This generic type of device includes prosthesis that have a femoral<br>component made of alloys, such as cobalt-chromium-molybdenum, and<br>a tibial component(s) and/or a retropatellar resurfacing component<br>made of ultra-high molecular weight polyethylene plus an additive, such<br>as a-tocopherol. |

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# 510(K) SUMMARY (PAGE 2 OF 5)

Indications for Use:

The iTotal PS 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, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

- Painful joint disease due to osteoarthritis, traumatic arthritis, . rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity. �
- Failed osteotomies, hemiarthroplasties, and unicondylar, . patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks . necessary for alignment and positioning of the implant are identifiable on patient imaging scans

## This implant is intended for cemented use only.

ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: ============================================================================================================================================================================== Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K131467 & K131019

DePuy Attune Knee System Device Class: == Product Code: JWH, OIY Regulation Number: 21 CFR 888.3560 510(k) number: K111433

Zimmer Persona Personalized Knee System Device Class: ll Product Code: JWH Regulation Number: 21 CFR 888.3560 510(k) number: K113369

Identification of the Legally Marketed Device (Predicate Device):

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#### 510(K) SUMMARY (PAGE 3 OF 5)

#### Device Description:

The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate (iTotal CR KRS), ancillary orthopedic manual surgical instruments designed for use with the iTotal PS KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K131467 & K131019. There are only a few differences such as the addition of jigs to guide the bone cutting for the femoral box, the introduction of a full thickness flexion spacer to help assess joint space, and the insert trials that are made to match the tibial insert with the spine feature.

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# 510(K) SUMMARY (PAGE 4 OF 5)

#### Substantial Equivalence:

The product subject of this premarket notification is substantially equivalent in design and functionality to the iTotal Cruciate Retaining Knee Replacement System (K131467, cleared July 18, 2013 & K131019, cleared May 24, 2013); the DePuy Attune PS Total Knee System (K111433, cleared August 30, 2011); and the Zimmer Persona PS Personalized Knee System (K113369, cleared March 27, 2012).

Functional testing was conducted in compliance with the FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003.

Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:

- Femoral Component Fatigue Testing .
- . Tibial Tray Fatigue Testing
- Tibial Insert Spine-Femoral Cam Fatigue Testing .
- Tibiofemoral Contact Area and Surface Stress Testing .
- Patellofemoral Contact Area and Surface Stress Testing .
- Patellofemoral Lateral Stability Testing .
- Tibiofemoral Constraint Analysis .
- Rotational Laxity Testing .
- Range of Motion Analysis t
- Tibial Interlock Strength Testing .
- . Tibial Insert Push-in/ Push-out Testing
- Cadaveric Evaluation .
- Software verification and validation testing .
- . MR Compatibility Testing

All testing has demonstrated that the device is substantially equivalent to the predicate devices.

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| Description and<br>Conclusion of Testing: | Nonclinical Testing: The determination of substantial equivalence for this<br>device was based on a detailed device description and non-clinical<br>laboratory testing. Testing on the iTotal PS Knee Replacement System<br>included functional testing in compliance with The FDA Guidance Class II<br>Special Controls Class II Special Controls Guidance Document: Knee Joint<br>Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated<br>Uncemented Prostheses; Guidance for Industry and FDA, issued January<br>16, 2003.<br><br>Specifically, the following non-clinical laboratory tests were performed to<br>determine substantial equivalence:<br>Femoral Component Fatigue Testing Tibial Tray Fatigue Testing Tibial Insert Spine-Femoral Cam Fatigue Testing Tibiofemoral Contact Area and Surface Stress Testing Patellofemoral Contact Area and Surface Stress Testing Patellofemoral Lateral Stability Testing Tibiofemoral Constraint Analysis Rotational Laxity Testing Range of Motion Analysis Tibial Interlock Strength Testing Tibial Insert Push-in/Push-out Testing Cadaveric Evaluation Software verification and validation testing MR Compatibility Testing Test results demonstrated that the device is safe and can be considered<br>substantially equivalent to the predicate devices for the intended use. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance: | The determination of substantial equivalence for this device was based on<br>a detailed device description and non-clinical laboratory testing. The<br>testing demonstrated that the device is safe for its intended use and can<br>be considered substantially equivalent to the predicate devices. Clinical<br>data is not necessary to demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted, it is concluded that the iTotal Posterior<br>Stabilized Knee Replacement System is substantially equivalent to the<br>predicate devices: the iTotal Cruciate Retaining Knee Replacement<br>System (K131467, cleared July 18, 2013, & K131019, cleared May 24,<br>2013); the DePuy Attune PS Total Knee System (K111433, cleared August<br>30, 2011); and the Zimmer Persona PS Personalized Knee System<br>(K113369, cleared March 27, 2012). |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 0903 New Hamnshire Avenue Document Control Control Conter - WC66-G609 Silver Spring, MI) 20993-0002

June 30, 2014

ConforMIS. Incorporated Ms. Amita Shah Senior Vice-President, Regulatory & Quality Affairs 28 Crosby Drive Bedford. Massachusetts 01730

Re: K140833

Trade/Device Name: ConforM1S iTotal* Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS) 、 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OOG. OIY Dated: March 31, 2014 Received: April 2, 2014

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. Ilisting 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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#### Page 2 - Ms. Amita Shah

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. T

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

ﻨﺘﻬﺎ

Sincerely yours,

# Lori A. Wiggins

for

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

Enclosure

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#### K140833

#### Indications for Use

K140833 510(k) Number (if known): _

Device Name:

ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (ITotal PS KRS)

## Indications for Use:

The iTotal PS 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

- Painful joint disease due to osteoarthritis, traumatic arthritis, theumatoid arthritis, polyarthritis . or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity. .
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental . implants.
- . Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is Intended for cemented use only.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

**Casey L. Hanley, Ph.D.**
Division of Orthopedic Devices

Traditional 510(k) - iTotal PS KRS