ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K122033 · Conformis, Inc. · JWH · Sep 27, 2012 · Orthopedic

Device Facts

• Record ID: K122033
• Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

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 bi-compartmental implants. The implant is intended for cemented use only

Device Story

Patient-specific tricompartmental posterior cruciate ligament (PCL) retaining knee replacement system; consists of femoral, tibial, and patellar components. Inputs: patient CT or MR scans. Processing: proprietary iTotal iView software designs patient-specific implants and manual surgical instruments to match patient anatomy. Output: custom-fit CoCrMo femoral/tibial components and UHMWPE inserts/patellar components; patient-specific nylon cutting jigs. Used in clinical settings by surgeons for cemented total knee arthroplasty. Benefits: bone-preserving approach; improved fit via patient-specific geometry; assists in intra-operative positioning and bone resection.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical laboratory testing, including detailed software verification and validation of the proprietary iTotal iView software.

Technological Characteristics

Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE (tibial insert/patellar component). Design: Semi-constrained, cemented, fixed-bearing, PCL-retaining. Instrumentation: Patient-specific nylon jigs. Sterilization: VHP Gas Plasma (1x10-6 SAL). Software: Proprietary iTotal iView for patient-specific design.

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, or moderate varus/valgus/flexion deformity where ligamentous stability can be restored, or following failed prior partial/compartmental implants. Contraindicated for patients whose condition can be addressed 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 CR KRS (K094050)
• iTotal CR KRS (K103117)
• iTotal CR KRS (K112780)
• iTotal CR KRS (K120068)
• iTotal CR KRS (K113378)
• iTotal CR KRS (K120316)

Submission Summary (Full Text)

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K122033('/6

2017

# 5.0 510(K) SUMMARY:

Page 1 of 6

| Submitter's Name<br>and Address | ConforMIS Inc.<br>11 North Ave.<br>Burlington, MA 01803 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration<br>Number | 3004153240 and 3008690421 |
| Date of Summary | June 9, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and Regulatory<br>Affairs |
| Telephone Number | [phone] |
| Fax Number | [phone] |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or Usual<br>Name | Cruciate Retaining Total Knee Replacement<br>System |
| Classification<br>Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| Regulation Number | 21 CFR 888.3560 |
| Device<br>Classification | Product Code:<br>JWH, Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis.<br><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. |

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510(k) Summary continued Page 2 of 6 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 bi-compartmental implants. The implant is intended for cemented use only ConforMIS iTotal CR Knee Replacement System (KRS) ldentification of the Device Class: Legally Marketed ll JWH, OOG Device Product Code: (Predicate Device) Requlation Number: 21 CFR 888.3560 K094050, K103117, K112780, K113378, 510(k) number: K120068, K120316

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### 510(k) Summary continued Page 3 of 6

The iTotal Cruciate Retaining Knee Replacement System (hereafter Device Description referred to as the "iTotal CR KRS") is a patient-specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.

> Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software, a patient-specific implant and related instrumentation are designed that best meet 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 either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.

> For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR 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 quiding the marking of bone before cutting.

> The function and general design features of the patient-specific ancillary instruments remain similar to those described in the predicate 510k i.e. K094050, K103117, K112780, K120068, K113378 and K120316.

Substantial Equivalence:

The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 7, 2011, K112780 cleared December 15, 2011, K120068 cleared February 3, 2012, K113378 cleared February 15, 2012 and K120316 cleared April 19, 2012) The following testing was performed to establish substantial equivalence:

- Software verification and validation testing of proprietary t software iTotal iView

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510(k) Summary continued Page 4 of 6

# Device Comparison

| Characteristic | Modified iTotal CR KRS (This submission) | Predicate iTotal CR KRS (K112780 and<br>K120316) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The iTotal® CR Knee Replacement System is<br>intended for use as a total knee replacement<br>in patients with knee joint pain and disability<br>whose conditions cannot be solely addressed<br>by the use of a prosthetic device that treats<br>only one or two of the three knee<br>compartments, such as a unicondylar, patello-<br>femoral or bi-compartmental prosthesis. The<br>indications for use include:<br>• Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or osteonecrosis<br>of the knee.<br>• Post traumatic loss of joint function.<br>• Moderate varus, valgus or flexion<br>deformity in which the ligamentous<br>structures can be returned to<br>adequate function and stability.<br>• Failed osteotomies,<br>hemiarthoplasties, and unicondylar,<br>patello-femoral or bi-compartmental<br>implants. | The iTotal® CR Knee Replacement System is<br>intended for use as a total knee replacement<br>in patients with knee joint pain and disability<br>whose conditions cannot be solely addressed<br>by the use of a prosthetic device that treats<br>only one or two of the three knee<br>compartments, such as a unicondylar, patello-<br>femoral or bi-compartmental prosthesis. The<br>indications for use include:<br>• Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or osteonecrosis<br>of the knee.<br>• Post traumatic loss of joint function.<br>• Moderate varus, valgus or flexion<br>deformity in which the ligamentous<br>structures can be returned to<br>adequate function and stability.<br>• Failed osteotomies,<br>hemiarthoplasties, and unicondylar,<br>patello-femoral or bi-compartmental<br>implants. |
| The implant is intended for cemented use only | The implant is intended for cemented use only | The implant is intended for cemented use only |
| Intended for Cement<br>Use Only | Yes | Yes |
| Product<br>Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Components | • Femoral Component<br>• Metal Backed Tibial Component<br>• Patellar Component | • Femoral Component<br>• Metal Backed Tibial Component<br>• Patellar Component |
| Materials | • Femoral Implant- CoCrMo<br>• Metal-Backed Tibial Components:<br>◦ Tibial tray- CoCrMo<br>◦ Tibial Insert-UHMWPE<br>• Patellar Component: UHMWPE | • Femoral Implant- CoCrMo<br>• Metal-Backed Tibial Components:<br>◦ Tibial tray- CoCrMo<br>◦ Tibial Insert-UHMWPE<br>• Patellar Component: UHMWPE |
| Characteristic | Modified iTotal CR KRS (This submission) | Predicate iTotal CR KRS (K112780 and<br>K120316) |
| Design | Knee joint patellofemorotibial semi - constrained cemented prosthesis | Knee joint patellofemorotibial semi - constrained cemented prosthesis |
| Configuration-<br>Femoral Implant | Constant coronal curvature Patient-specific sagittal J- curves | Constant coronal curvature Patient-specific sagittal J- curves |
| Tibial Implant | Configuration: Metal Backed Tibial<br>Implant Single or Dual inserts Insert sizes:6-16mm Articulating Surface: curved Profile: patient-specific Tray interlock: Interference fit Anterior lip Tray undercut design | Configuration: Metal Backed Tibial<br>Implant Single or Dual inserts Insert sizes:6-16mm Articulating Surface: curved Profile: patient-specific Tray interlock: Interference fit Anterior lip Tray undercut design |
| Patellar Implant | Symmetrical, offered in sizes ranging from 32,<br>35, 38, 41 and 44 mm, with corresponding<br>heights of 6, 7, 8.5, 10 and 12mm. | Symmetrical, offered in sizes ranging from 32,<br>35, 38, 41 and 44 mm, with corresponding<br>heights of 6, 7, 8.5, 10 and 12mm. |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Principle of<br>Operation | Cemented use<br>Fixed Bearing Design | Cemented use<br>Fixed Bearing Design |
| Posterior Cruciate<br>Ligament (PCL)<br>Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| Packaging | Device components are individually double<br>pouched using Tyvek® /film pouches which<br>are sealed and labeled | Device components are individually double<br>pouched using Tyvek® /film pouches which<br>are sealed and labeled |
| Patient-specific<br>surgical plan | Generated by iTotal iView software or<br>manually generated | Manually generated |
| Sterility Method/<br>Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 |
| Initial Shelf-Life | 6 months | 6 months |
| Labeled Non-<br>pyrogenic | No | No |

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#### 510(k) Summary continued Page 5 of 6

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510(k) Summary continued Page 6 of 6

.

| Description and<br>Conclusion of<br>Testing | Nonclinical Testing: The determination of substantial equivalence for<br>this device was based on a detailed device description. The following<br>non-clinical laboratory testing was performed demonstrating that the<br>device is safe and can be considered substantially equivalent to the<br>predicate device for the intended use:<br>• Detailed software description and software verification and<br>validation testing of proprietary software |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and | |
| 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 intended use.<br>Clinical data is not necessary to demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted, it is concluded that the iTotal Cruciate<br>Retaining Knee Replacement System with the use of the iTotal iView<br>production software is substantially equivalent to the iTotal Cruciate<br>Retaining Knee Replacement System (K094050 cleared September 16,<br>2010, K103117 cleared January 7, 2011, K112780 cleared Dec 15,<br>2011, K120068 cleared on February 3, 2012 and K113378 cleared on<br>February 15, 2012 and K120316 cleared April 19, 2012. |

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

2 7 2012

Conformis, Incorporated
% Ms. Amita S. Shah
Vice President, Quality Assurance and Regulatory Affairs
11 North Ave
Burlington, Massachusetts 01803

Re: K122033

Trade/Device Name: ConforMIS® iTotal Cruciate 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, OOG Dated: July 9, 2012

Received: July 16, 2012

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

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

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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### Indications for Use

K122033 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, hemiatthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants.

The implant is intended for cemented use only.

Adf

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

510(k) Number K122033

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Traditional 510(k) - Modified iTotal® CR Knee Replacement System - iTotal iView