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, 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.
The implant is intended for cemented use only.

Device Description

The iTotal Cruciate Retaining 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 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 that are manufactured from UHMWPE. The patellar component is also manufactured from UHMWPE.
ConforMIS is proposing a line extension of the current iTotal CR Knee Replacement System. The proposed line extension consists of providing tibial inserts and patellae made from a highly cross linked Vitamin E infused polyethylene (iPoly XE) similar to the predicate Biomet E-Poly™ Tibial Bearings (K080528) and the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K113756, K103223, K091956).
The iPoly XE tibial inserts and patellae will be manufactured from ultra high molecular weight polyethylene (UHMWPE) that is blended with Vitamin E (alpha-tocopherol), compression molded and then highly crosslinked. Other than the material, the iPoly XE Tibial inserts are identical in design to those cleared for the iTotal CR KRS via K120316. The iPoly XE patellae are also identical in design to those cleared via K112780.
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 cutting of bone.

AI/ML Overview

The acceptance criteria and study details for the ConforMIS iTotal® Cruciate Retaining Knee Replacement System with iPoly XE™ Tibial Inserts and patellae are outlined below, based on the provided 510(k) summary (K122870).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical laboratory testing. The "acceptance criteria" are implied by the successful performance of these tests, indicating that the device's material properties and performance characteristics are comparable to or improved over the predicates, particularly regarding wear reduction.

Property / Characteristic Type	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Biocompatibility	Meets established biocompatibility standards for implantable devices (e.g., ISO 10993 series relevant tests).	All tested characteristics (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Sub Chronic Toxicity, Genotoxicity, Muscle Implantation) demonstrated that the device is safe, indicating compliance with biocompatibility requirements.
Physical and Mechanical Properties	Comparable strength, fatigue resistance, impact resistance, tensile properties, and compressive modulus to predicate devices, ensuring structural integrity and functional performance.	Tests (Small Punch Test, Fatigue Crack Growth Test, Izod Impact Test, Static Tensile Test, Compressive Modulus Test) showed performance suitable for the intended use and comparable to predicate devices.
Chemical Properties	Comparable chemical composition and material characteristics (e.g., cross-link density, vitamin E content, oxidation resistance) to predicate vitamin E infused UHMWPE materials.	Tests (Scanning Electron Microscopy analysis, Differential Scanning Calorimetry analysis, Free Radical Content, Oxidization Index, Extraction analysis, Residue on extraction, Uniformity of radiation dose, Cross-link Density, Vitamin E Content, Ash Content, Environmental Stress Cracking) confirmed the material properties, including the successful integration of Vitamin E and cross-linking as described.
Performance Testing	Comparable or improved wear performance, contact area/stress, and mechanical integrity (interlock strength, patella subluxation resistance) compared to predicate devices.	- Wear Testing: In-vitro knee simulator wear testing demonstrated a significant gravimetric wear reduction for the iTotal CR KRS with iPoly XE compared to the iTotal CR KRS with conventional polyethylene tibial inserts. (Note: The submission explicitly states "The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.")- Other Performance Tests: Tibiofemoral Contact Area/Stress, Strength of Tibial interlock, Patella Shear Test, Patella Tensile Test, Patellofemoral Contact Area/Stress Test, Wear Testing under abrasive conditions, Analysis of wear debris were conducted and results supported substantial equivalence.
Electromagnetic Compatibility	Compatibility with MRI environments, ensuring patient safety and device integrity during MRI scans.	Evaluation demonstrated the safety and compatibility of the iTotal CR Knee Replacement System within the MRI Environment.

The study concluded that: "All testing has demonstrated the device is substantially equivalent to the predicate devices." and specifically, "Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate device for the intended use."

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not explicitly state the specific sample sizes for each non-clinical laboratory test (e.g., number of samples for wear testing, mechanical testing). These are typically detailed in the full test reports, which are not included in the 510(k) summary.

Data Provenance: The data is retrospective in the sense that it's laboratory testing conducted on the manufactured device components. The data origin is from the manufacturer's (ConforMIS Inc.) internal testing or contracted testing laboratories. There is no mention of country of origin for the data provided directly in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a medical implant (knee replacement system), and the testing performed is non-clinical laboratory testing (material properties, mechanical performance, wear simulation, biocompatibility). Clinical performance is not evaluated in this submission for substantial equivalence. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic AI/imaging devices.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective laboratory data against predefined engineering and material standards, not expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a submission for a knee implant, not an AI-assisted diagnostic or clinical decision support device. Therefore, no MRMC studies or AI-related effectiveness studies were part of this 510(k).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This submission is for a knee implant. While the device utilizes patient-specific design based on imaging (CT or MR scans) and "proprietary and off the shelf software" for design, the submission does not describe this software as an "algorithm" in the context of standalone diagnostic or assistive AI performance. The focus is on the physical implant's material and mechanical properties, not the performance of the design software as a medical device in itself.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical laboratory testing is established by:

Known material specifications and standards: e.g., for UHMWPE, Vitamin E content, CoCrMo alloy properties.
Industry standards and test methods: e.g., ISO 14243 for wear testing, ISO 10993 for biocompatibility.
Pre-defined engineering and design requirements: Ensuring the device meets its functional criteria (e.g., interlock strength, contact stress).
Comparisons to predicate devices: The "ground truth" for determining substantial equivalence is largely the established safety and effectiveness of the legally marketed predicate devices through comparable test results.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of AI/machine learning for this submission. The device design process involves using patient imaging data, but that's for individual patient-specific device creation, not for training a generalizable AI model described in this summary.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

Summary

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K122870

510(K) SUMMARY

JAN 1 4 2013

Submitter's Nameand Address	ConforMIS Inc.11 North Ave.Burlington, MA 01803
EstablishmentRegistrationNumber	3004153240
Date of Summary	December 27, 2012
Contact Person	Amita S. Shah, Vice President, Quality & Regulatory Affairs
Telephone Number	(781) 345-9164
Fax Number	(781) 345-0104
Name of the Device	ConforMIS iTotal® Cruciate Retaining Knee Replacement System withiPoly XE™ Tibial Inserts and patellae
Common or UsualName	Cruciate Retaining Total Knee ReplacementSystem
ClassificationName	Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis
Regulation Number	21 CFR 888.3560
DeviceClassification	Product Code:JWH, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.OIY, Prosthesis, knee, patellofemorotibial, semi-constrained, cementedpolymer + additive/metal/polymer + additive. This generic type of deviceincludes prosthesis that have a femoral component mode of alloys, such ascobalt-chromium-molybdenum, and a tibial component(s) and/or aretropatellar resurfacing component made of ultra-high molecular weightpolyethylene plus an additive, such as a-tocopherol.OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Intended to be used to assist in theimplantation of a specific knee arthroplasty device or a set of specific kneearthroplasty devices. Indicated to include guiding alignment, making orestablishing cuts, selecting, sizing, attaching, positioning or orientingimplant components.

Traditional 510(k) - iTotal® CR KRS- iPoly XE Inserts & Patellae

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161228 20

510(k) Summarycontinued
Indications for Use	The iTotal® CR Knee Replacement System is intended for use as a totalknee replacement in patients with knee joint pain and disability whoseconditions cannot be solely addressed by the use of a prosthetic devicethat treats only one or two of the three knee compartments, such as aunicondylar, 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 theligamentous structures can be returned to adequate function andstability. Failed osteotomies, hemiarthroplasties, and unicondylar,patellofemoral or bicompartmental implants Revision procedures provided that anatomic landmarks necessaryfor alignment and positioning of the implant are identifiable onpatient imaging scans. The implant is intended for cemented use only
Identification of theLegally MarketedDevices(Predicate Devices)	Device Class:	ConforMIS iTotal CR Knee Replacement System (KRS)
	Product Code:	JWH, OOG
	Regulation Number:	21 CFR 888.3560
	510(k) number:	K120316, K120068, K113378, K112780, K103117,K094050
	Device Class:	Biomet E-Poly™ Tibial Bearings
	Product Code:	JWH, MBH, MBV, OIY
	Regulation Number:	21 CFR 888.3560
	510(k) number:	K080528
	Device Class:	DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella
	Product Code:	JWH, MBH, OIY

Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae

p, 2 of 8

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K122870

Regulation Number: 21 CFR 888.3560 K113756. K103223. K091956 510(k) number:

510(k) Summary continued

Device Description

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 that are manufactured from UHMWPE. The patellar component is also manufactured from UHMWPE.

ConforMIS is proposing a line extension of the current iTotal CR Knee Replacement System. The proposed line extension consists of providing tibial inserts and patellae made from a highly cross linked Vitamin E infused polyethylene (iPoly XE) similar to the predicate Biomet E-Poly™ Tibial Bearings (K080528) and the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K113756, K103223, K091956).

The iPoly XE tibial inserts and patellae will be manufactured from ultra high molecular weight polyethylene (UHMWPE) that is blended with Vitamin E (alpha-tocopherol), compression molded and then highly crosslinked. Other than the material, the iPoly XE Tibial inserts are identical in design to those cleared for the iTotal CR KRS via K120316. The iPoly XE patellae are also identical in design to those cleared via K112780.

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 cutting of bone.

p. 3.fd

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K122870

The function and general design features of the patient specific ancillary
instruments remain similar to those described in the predicate iTotal CR
510ks (K120316, K120068, K113378, K112780, K103117, K094050).

Substantial
Equivalence:
The product subject of this premarket notification is substantially equivalent
in design and functionality to the iTotal Cruciate Retaining Knee
Replacement System (K112780 cleared December 15, 2011 and K120316
cleared April 19, 2012). The iPoly XE tibial bearing material is similar to
the material used in the Biomet E-Poly Tibial bearings (K080528 cleared
June 17, 2008), and the DJO Surgical Highly Cross-Linked UHMWPE
Tibial Insert and Patella (K091956 cleared September 28, 2010, K103223
cleared December 21, 2010 and K113756 cleared March 14, 2012)

The following non-clinical laboratory testing was performed to determine
substantial equivalence:

Material properties of iPoly XE
- Physical and Mechanical testing
- Chemical Analysis
Biocompatibility Testing of iPoly XE
Performance testing of iPoly XE inserts and patellae
- Wear testing
- Contact area/contact stress testing
- Tibial implant interlock testing
- Patella subluxation testing

In-vitro knee simulator wear testing provided in the submission
demonstrated that the iTotal CR KRS with iPoly XE exhibited a significant
gravimetric wear reduction as compared to the iTotal CR KRS with
conventional polyethylene tibial inserts. The results of in-vitro wear

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

simulation testing have not been proven to quantitatively predict clinical

wear performance.

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Total CR KRS with iPoly XE (This	Predicate iTotal CR KRS (K112780 and K120316)	Biomet E-Poly Tibial Bearings K080528	Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756
Knee Replacementfor use as a total kneereplacements with knee joint painand disability whose conditions cannot besolely addressed by the use of a prostheticdevice that treats only one or two of thethree knee compartments, such as aunicondylar, patellofemoral orbicompartmental prosthesis. Theindications for use include:	The iTotal® CR Knee Replacement Systemis intended for use as a total kneereplacement in patients with knee joint painand disability whose conditions cannot besolely addressed by the use of a prostheticdevice that treats only one or two of thethree knee compartments, such as aunicondylar, patellofemoral orbicompartmental prosthesis. The indicationsfor use include:	Indications for Use:1. Painful and disabled knee joint resulting fromosteoarthritis, rheumatoid arthritis,traumatic arthritis where one or morecompartments are involved.2. Correction of varus, valgus, or posttraumaticdeformity..3. Correction or revision of unsuccessfulosteotomy, arthrodesis, or failure ofprevious joint replacement procedure.	Joint replacement is indicated for patients sufferingfrom disability due to:
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 or bi-compartmental implants.	Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis orosteonecrosis of the knee. Post traumatic loss of jointfunction. Moderate varus, valgus or flexiondeformity in which theligamentous structures can bereturned to adequate functionand stability. Failed osteotomies,hemiarthroplasties, andunicondylar, patellofemoral or bi-compartmental implants.	For cemented and un-cemented use.	degenerative, post-traumatic or rheumatoidarthritis; avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration,particularly when there is patellofemoralerosion dysfunction or prior patellectomy; moderate valgus, varus or flexiondeformities; Treatment of fractures that areunmanageable using other techniques
osteotomies,hemiarthroplasties, andunicondylar, patellofemoral orcompartmental implants. procedures providedatomic landmarksary for alignment anding of the implant areble on patient imagingonly	The implant is intended for cemented useonly		This device may also be indicated in the salvage ofpreviously failed surgical attempts.
intended for cemented use			This device is intended to be used with the 3DKneeSystem for cemented or uncemented applications.
			Note: Patella component is only intended forcemented use
Characteristic	iTotal CR KRS with iPoly XE (This submission)	Predicate iTotal CR KRS (K112780 and K 120316)	Biomet E-Poly Tibial Bearings K080528	Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756
Intended for Cement Use Only	Yes	Yes	No	No
Product classification	21 CFR 888.3560 (JWH)	21 CFR 888.3560 (JWH)	21 CFR 888.3560	21 CFR 888.3560
Materials	Metal-Backed Tibial Components:Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar Component: Vitamin E infused highly cross-linked UHMWPE	Metal-Backed Tibial Components:Tibial tray- CoCrMo Tibial Insert-UHMWPE Patellar Component: UHMWPE	Metal-Backed Tibial Components:Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component- UHMWPE	Metal-Backed Tibial Components:Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component - Vitamin E infused highly cross-linked UHMWPE
Design	Knee joint patellofemorotibial semi – constrained cemented prosthesis	Knee joint patellofemorotibial semi -constrained cemented prosthesis	Knee joint patellofemorotibial semi-constrained cemented prosthesis	Knee joint patellofemorotibial polymer/metal!/polymer semi-constrained cemented prosthesis
Tibial Implant	Configuration: Metal Backed Tibial ImplantTibial Insert-Vitamin E infused highly cross-linked UHMWPESingle or Dual inserts Insert sizes:6-16mm Profile: patient specific	Configuration: Metal Backed Tibial ImplantTibial Insert- UHMWPESingle or Dual inserts Insert sizes:6-16mm Profile: patient specific	Configuration: Metal Backed Tibial ImplantTibial Insert-Vitamin E infused highly cross-linked UHMWPESingle inserts Five insert sizes – five thickness/size	Configuration: Metal Backed Tibial ImplantTibial Insert-Vitamin E infused highly cross- linked UHMWPESingle inserts 9 insert sizes (2-12) and 5 thicknesses (9-19)
Instrumentation	Patient specific Nylon jigs	Patient specific Nylon jigs	Non Patient-specific jigs	Unknown
Principle of Operation	Cemented useFixed Bearing Design	Cemented useFixed Bearing Design	Cemented or un-cemented useFixed Bearing Design	Cemented or un-cemented useFixed Bearing Design
Posterior Cruciate Ligament (PCL) Sparing	Yes	Yes	Yes	Yes
Patient-Matched	Yes	Yes	No	No
Characteristic	iTotal CR KRS with iPoly XE (This submission)	Predicate iTotal CR KRS (K112780 and K120316)	Biomet E-Poly Tibial Bearings K080528	Encore -DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756
Packaging	Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled	Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled	Unknown	Unknown
Sterility Method/Assurance Level	VHP Gas Plasma 1x10-6	VHP Gas Plasma 1x10-6	Unknown	VHP Gas Plasma
Initial Shelf-Life	6 months	6 months	Unknown	Unknown
Labeled Non-pyrogenic	No	No	No	No

raditional 510(k) – iTotal® CR KRS– iPoly XE Inserts & Patellae

( -- -- -- -- -- -- --

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Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae

p. 66f8

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Traditional 510(k) – iTotal® CR KRS-- iPoly XE™ Inserts & Patellae

K12-2870

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K122870

Description and	The determination of substantial equivalence for this device was based
Conclusion of	on a detailed device description and non-clinical laboratory testing.
Testing	Testing on the iPoly XE outlined below:

Property /Characteristic	Tests conducted
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Irritation, SystemicToxicity, Material Mediated Pyrogenicity, Sub Chronic Toxicity,Genotoxicity, Muscle Implantation
Physical and Mechanical Properties	Small Punch Test, Fatigue Crack Growth Test, Izod Impact Test,Static Tensile Test, Compressive Modulus Test
Chemical Properties	Scanning Electron Microscopy analysis, Differential ScanningCalorimetry analysis, Free Radical Content, Oxidization Index,Extraction analysis, Residue on extraction, Uniformity of radiationdose, Cross-link Density, Vitamin E Content, Ash ContentEnvironmental Stress Cracking,
Performance Testing	Tibiofemoral Contact Area/Stress, Strength of Tibial interlock,Patella Shear Test, Patella Tensile Test, Patellofemoral ContactArea/Stress Test, Wear Testing per ISO 14243. Wear Testingunder abrasive conditions, Analysis of wear debris.
Electromagnetic Compatibility	Evaluation of the Safety and Compatibility of the iTotal CR KneeReplacement System within the MRI Environment
Test results demonstrated that the device is safe and can be considered substantially equivalent to the

predicate device for the intended use.

Safety and Performance

The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices. Clinical data is not necessary to demonstrate substantial equivalence.

Conclusion:

Based on the testing conducted, it is concluded that the iTotal Cruciate Retaining Knee Replacement System with iPoly XE tibial inserts and patellae is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System K112780 cleared December 15, 2011, K120316 cleared April 19, 2012, K080528 (Biomet) cleared June 17, 2008, K091956 (DJO Surgical) cleared September 28, 2010, K103223 (DJO Surgical) cleared December 21, 2010, and K113756 (DJO Surgical) cleared March 14, 2012.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: January 14, 2013

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

Conformis, Incorporated % Ms. Amita Shah Vice President, Ouality & Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803

Re: K122870

. 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 semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH, OOG Dated: December 6, 2012

Received: December 7, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{9}------------------------------------------------

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 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/ReportalProblem/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,

Mark N. Melkerson

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): K122870

Device Name:

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

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.

The implant is intended for cemented use only.

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) 01.14 13:28:56 Anton E. Dmitriev, PhD Division of Orthopedic Devices

Traditional 510(k) - iTotal® CR KRS- iPoly XE™ Inserts & Patellae

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.