The iTotal CR 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 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, 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 Description

The iTotal CR Knee Replacement System (hereafter 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.

Using patient imaging (either CT or MR scans) 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 indudes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also 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, 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 guiding 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 510(k) K122870.

AI/ML Overview

This device is not an AI/ML device, and therefore the acceptance criteria and study information is not applicable in the requested format.

The ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) is a traditional medical device (a knee replacement system) and not an AI/ML powered device. The document describes a 510(k) summary for a modified version of an already cleared device, focusing on demonstrating substantial equivalence to the predicate device.

The "testing" mentioned is non-clinical laboratory testing to establish substantial equivalence for the modified device, specifically:

Patella fixation testing
Steam Sterilization Validation and Product Performance for metal implants and iJig Instrumentation post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.

These are standard engineering and sterilization validation tests for physical implants and instruments, not performance metrics for an AI/ML algorithm. Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this submission.

Summary

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8.0 510(K) SUMMARY

JUL 1 8 2013

Submitter's Nameand Address	ConforMIS Inc.28 Crosby DriveBedford, MA 01730
EstablishmentRegistration Number	3009844603
Date of Summary	July 17, 2013
Contact Person	Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs
Telephone Number	(781) 345-9164
Fax Number	(781) 345-0104
Name of the Device	ConforMIS iTotal® CR Knee Replacement System (iTotal CRKRS)
Common or UsualName	Cruciate Retaining Total Knee Replacement System
Classification Name	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella

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510(K) Summary Continued

Device Classification	Product Code:JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
	OOG: Knee Arthroplasty Implantation System.Intended to be used to assist in the implantation of a specific kneearthroplasty device or a set of specific knee arthroplasty devices.Indicated to include guiding alignment, making or establishing cuts,selecting, sizing, attaching, positioning or orienting implantcomponents.
	OIY: Prosthesis, knee, patellofemorotibial, semi-constrained,cemented polymer + additive/metal/polymer + additive. Thisgeneric type of device includes prosthesis that have a femoralcomponent made of alloys, such as cobalt-chromium-molybdenum,and a tibial component(s) and/or a retropatellar resurfacingcomponent made of ultra-high molecular weightpolyethylene plus an additive, such as a-tocopherol.
Indications for Use	The iTotal CR Knee Replacement System (KRS) is intended foruse as a total knee replacement in patients with knee joint painand disability whose conditions cannot be solely addressed by theuse of a prosthetic device that treats only one or two of the threeknee compartments, such as a unicondylar, patellofemoral orbicompartmental prosthesis.The Indications for Use include:• Painful joint disease due to osteoarthritis, traumaticarthritis, rheumatoid arthritis or osteonecrosis of the knee.• Post traumatic loss of joint function.• Moderate varus, valgus or flexion deformity in whichthe ligamentous structures can be returned toadequate function and stability.• Failed osteotomies, hemiarthroplasties, andunicondylar, patellofemoral or bicompartmentalimplants.• Revision procedures provided that anatomiclandmarks necessary for alignment and positioning ofthe implant are identifiable on patient imaging scans.This implant is intended for cemented use only.

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510(K) SUMMARY CONTINUED

Identification of the Legally Marketed Device(Predicate Device)	ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS)
Device Class:	II
Product Code:	JWH, OOG, OIY
Regulation Number:	21 CFR 888.3560
510(k) number:	K122870

Device Description

The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510(k) K122870.

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510(K) SUMMARY CONTINUED

Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K122870 cleared January 14, 2013). The following testing was performed to establish substantial equivalence:

Patella Fixation Testing -
Steam Sterilization Validation and Product Performance for Metal Implants and iJig Instrumentation post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.

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510(k) Summary continued

Device Comparison

Attribute	PredicateiTotal CR Knee ReplacementSystem(K122870)	Modified DeviceiTotal CR Knee ReplacementSystem(This submission)
Components	Femoral Component Tibial Implant Metal Backed Tibial Component Patellar component	Femoral Component Tibial Implant Metal Backed Tibial Component Patellar component
Materials	Femoral Implant: CoCrMo Metal Backed TibialComponents: Tibial tray: CoCrMo Tibial Inserts: UHMWPEor iPoly XE All Polymer Patellar Component:UHMWPE or iPoly XE	Femoral Implant: CoCrMo Metal Backed TibialComponents: Tibial tray: CoCrMo Tibial Inserts: UHMWPEor iPoly XE All Polymer Patellar Component:UHMWPE or iPoly XE
Design	Knee joint patellofemorotibial semi-constrained cemented prosthesis	Knee joint patellofemorotibial semi-constrained cemented prosthesis
Principle ofOperation	Cemented Use Fixed BearingDesign	Cemented Use Fixed Bearing Design
Attribute	PredicateiTotal CR Knee ReplacementSystem(K122870)	Modified DeviceiTotal CR Knee ReplacementSystem(This submission)
Indications forUse	The iTotal CR Knee ReplacementSystem (KRS) is intended for use asa total knee replacement in patientswith knee joint pain and disabilitywhose conditions cannot be solelyaddressed by the use of a prostheticdevice that treats only one or two ofthe three knee compartments, suchas a unicondylar, patellofemoral orbicompartmental prosthesis.The Indications for Use include:• Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis orosteonecrosis of the knee.• Post traumatic loss of jointfunction.• Moderate varus, valgus orflexion deformity in which theligamentous structures can bereturned to adequate functionand stability.• Failed osteotomies,hemiarthroplasties, andunicondylar, patellofemoral orbicompartmental implants.• Revision procedures providedthat anatomic landmarksnecessary for alignment andpositioning of the implant areidentifiable on patient imagingscans.This implant is intended forcemented use only.	The iTotal CR Knee ReplacementSystem (KRS) is intended for use asa total knee replacement in patientswith knee joint pain and disabilitywhose conditions cannot be solelyaddressed by the use of a prostheticdevice that treats only one or two ofthe three knee compartments, suchas a unicondylar, patellofemoral orbicompartmental prosthesis..The Indications for Use include:• Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis orosteonecrosis of the knee.• Post traumatic loss of jointfunction.• Moderate varus, valgus orflexion deformity in which theligamentous structures can bereturned to adequate functionand stability.• Failed osteotomies,hemiarthroplasties, andunicondylar, patellofemoral orbicompartmental implants.• Revision procedures providedthat anatomic landmarksnecessary for alignment andpositioning of the implant areidentifiable on patient imagingscans.This implant is intended forcemented use only.
Patient Matched	Yes	Yes
Attribute	PredicateiTotal CR Knee ReplacementSystem(K122870)	Modified DeviceiTotal CR Knee ReplacementSystem(This submission)
Tibial Implant	Configuration: Metal BackedTibial ImplantTibial Insert - UHMWPE oriPoly XESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific	Configuration: Metal BackedTibial ImplantTibial Insert - UHMWPE or iPolyXESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific
PosteriorCruciateLigament (PCL)Sparing	Yes	Yes
Instrumentation	Patient specific Nylon jigs	Patient specific Nylon jigs
Packaging	Device components are individuallydouble-pouched using Tyvek®/filmpouches which are sealed andlabeled	Device components are individuallydouble-pouched using Tyvek®/filmpouches which are sealed andlabeled
Sterility Method/Assurance Level	VHP Gas Plasma 1x10-6	VHP Gas Plasma 1x10-6
Instructions forIntra-OperativeSterilization	None	Steam Sterilization (SAL of 1x10-6)
Initial Shelf-Life	6 months	6 months
Labeled Non-pyrogenic	No	No
Patella Designand Sizes(diameter)	Symmetrical, offered in sizes: 32mm,35mm, 38mm, 41mm, 44mm	Symmetrical, offered in sizes, 29mm,32mm, 35mm, 38mm, 41mm, 44mm
Description andConclusion ofTesting	Nonclinical Testing: The determination of substantial equivalencefor this device was based on a detailed device description. Thefollowing non-clinical laboratory testing was performeddemonstrating that the device is safe and can be consideredsubstantially equivalent to the predicate device for the intendeduse:• Patella fixation testing• Steam Sterilization Validation and Product Performancepost steam sterilization to support instructions provided forsterilization of components in case of a loss of sterility.
Safety andPerformance	The determination of substantial equivalence for this device wasbased on a detailed device description. Non-clinical laboratorytesting was performed demonstrating that the device is safe andcan be considered substantially equivalent to the predicate devicefor the proposed intended use. Clinical data is not necessary todemonstrate substantial equivalence.
Conclusion	Based on the testing conducted it is concluded that the modifieddevice is substantially equivalent to the iTotal Cruciate RetainingKnee Replacement System K122870 cleared January 14, 2013.

Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella

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510(k) Summary continued

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Public Health Service

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

July 18, 2013

ConforMIS, Incorporated % Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Boston, Massachusetts 01730

Re: K131467

Trade/Device Name: iTotal® CR Knee Replacement System (KRS) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: May 31, 2013 Received: June 4, 2013

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

Image /page/8/Picture/11 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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Page 2 - Ms. Amita Shah

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address "

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

Sincerely yours,

Erin I. Keith

For

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

Enclosure

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Indications for Use

510(k) Number (if known): K131467

Device Name: iTotal CR Knee Replacement System

Indications for Use:

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, 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	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131467

Special 510(k) - Modified ITotal® CR Knee Replacement System - 29mm Patella

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.