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.
This implant is intended for cemented use only.

The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee replacement include those with:

. Joint impairment due to osteoarthritis or traumatic arthritis of the knee
Previous femoral condyle or tibial plateau fracture, . creating loss of function
. Valgus or varus deformity of the knee
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.

The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to :

. Painful joint disease due to osteoarthritis
Traumatic arthritis of the knee .
Post traumatic loss of joint function .
. Failed osteotomies, hemiarthroplasties and unicondylar implants
The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.
The iDuo implant is intended for cemented use only.

Device Description

ConforMIS knee replacement systems are patient-specific semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.

AI/ML Overview

This 510(k) submission describes the addition of Ethylene Oxide (EO) sterilization as an alternative to the existing VHP Gas Plasma sterilization for the ConforMIS iTotal CR Knee Replacement System, ConforMIS iUni Unicondylar Knee Replacement System, and ConforMIS iDuo Bicompartmental Knee Repair System. Therefore, the acceptance criteria and supporting study focus on demonstrating the safety and effectiveness of this new sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Summary of Study Results)
Sterility Assurance Level (SAL) of 1 x 10⁻⁶	Achieved (Sterilization Validation testing to establish a SAL of 1x10-6 was performed).
Ethylene Oxide (EO) Residual Limits Met	Achieved (EO residual testing was performed).
Product and Packaging Compatibility with Ethylene Oxide Sterilization	Achieved (Product and packaging compatibility with ethylene oxide sterilization was confirmed).
Substantial Equivalence to Predicate Devices	Concluded based on non-clinical testing showing safety and equivalent performance for intended use with the new sterilization method.

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

The document does not specify a separate "test set" in the context of an algorithm's performance on patient data. Instead, the testing pertains to the physical device and its sterilization process.

Sample Size for Sterilization Validation, EO Residual, and Material Compatibility Testing: The exact number of samples (devices and packaging materials) used for each test (sterilization validation, EO residual, product/packaging compatibility) is not explicitly stated in the provided text.
Data Provenance: The studies were non-clinical laboratory tests, likely conducted in a controlled lab environment. The country of origin is not specified, but the applicant (ConforMIS Inc.) is based in Bedford, MA, USA. The data is prospective in the sense that it was generated specifically for this submission to validate the new sterilization method.

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

Not applicable. This is not a study involving human interpretation of data for medical diagnosis or prognosis that would require expert-established ground truth. The "ground truth" here is objective scientific measurements related to sterilization efficacy and material properties.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving subjective assessments that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns device sterilization and material compatibility, not the comparative effectiveness of an AI algorithm in a clinical setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This submission does not involve an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for this submission is based on:

Objective scientific standards and methodologies: For sterility validation (e.g., demonstrating a SAL of 1x10⁻⁶), EO residual limits (based on established toxicological standards), and material compatibility (physical and chemical integrity of the device and packaging after sterilization).
Regulatory requirements and consensus standards: As governed by the FDA and referenced in the submission (e.g., 21 CFR regulations).

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm with a training set.

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

Not applicable.

Summary

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JAN - 9 2014

6.0 510(K) SUMMARY
Submitter's Name	ConforMIS Inc.28 Crosby DriveBedford, MA 01730
EstablishmentRegistrationNumber:	3009844603 and 3004153240
Date of Summary:	October 22, 2013
Contact Person:	Amita S. Shah, Sr. Vice President, Regulatory andQuality Affairs
Telephone Number:	(781) 345-9164
Fax Number:	(781) 345-0147
Name of theDevice(s):	ConforMIS iTotal CR Knee Replacement SystemConforMIS iUni Unicondylar Knee Replacement SystemConforMIS iDuo Bicompartmental Knee Repair System
Common Name(s):	Total Knee Replacement System
	Unicondylar Knee Replacement System
	Bicompartmental Knee Replacement System
Regulatory Statusand RegulationNumber:	Class II21 CFR 888.3560, 21 CFR 888.3520
DeviceClassification:	Class II
	Product Codes:
	JWH, Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis

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OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

NPJ, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

HSX, Knee joint femorotibial metal/polymer nonconstrained cemented prosthesis

Indications for Use:

iTotal

. 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.

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This implant is intended for cemented use only.

iUni

Candidates for unicondylar knee replacement include those with:

. Joint impairment due to osteoarthritis or traumatic arthritis of the knee
Previous femoral condyle or tibial plateau fracture, . creating loss of function
. Valgus or varus deformity of the knee
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.

iDuo

. Painful joint disease due to osteoarthritis
Traumatic arthritis of the knee .
Post traumatic loss of joint function .
. Failed osteotomies, hemiarthroplasties and unicondylar implants

The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.

The iDuo implant is intended for cemented use only.

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Identification of theLegally MarketedDevice(s) (PredicateDevice):
ConforMIS iTotal CR Knee Replacement SystemDevice Class: IIProduct Code: JWH, OOGRegulation Number: 21 CFR 888.3560510(k) Number: K131467 and K131019	ConforMIS knee replacement systems are patient-specific semi-constrained knee implants which consist ofa femoral, tibial, and/or patellar components. Theproducts are intended for treatment of severe pain and/ordisability of the knee damaged by osteoarthritis ortrauma.Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets thegeometric and anatomic requirements of the specificpatient. The femoral components of the devices aremanufactured from cobalt chromium molybdenum(CoCrMo) alloy. The tibial component includes a metaltray manufactured from CoCrMo alloy and polyethyleneinserts manufactured from UHMWPE or an allpolyethylene tibial component. The patellar componentsare manufactured from UHMWPE.
ConforMIS iUni Unicondylar Knee Replacement SystemDevice Class: IIProduct Code: HSX, OOGRegulation Number: 21 CFR 888.3520510(k) Number: K121974 and K111916
ConforMIS iDuo Bicompartmental Knee Repair SystemDevice Class: IIProduct Code: NPJ, OOGRegulation Number: 21 CFR 888.3560510(k) Number: K093513
Device Description:

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Substantial	The products subject to this premarket notification are
Equivalence:	substantially equivalent to the predicate devices.The following testing was performed to establishsubstantial equivalence:

Sterilization Validation to Sterility Assurance . Level (SAL) of 1x10-6 .
. Ethylene Oxide (EO) Residual Testing
Product and packaging compatibility with ethylene . oxide sterilization

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Device Comparison

	iTotal CR Knee ReplacementSystem (K131467 and K131019)iUni Unicondylar Knee ReplacementSystem (K121974 and K111916)Duo Bicompartmental Knee RepairSystem (K093513	Replacement SystemDuo Bicompartmental Kne
	Femoral Implant: CoCrMoTibial Implanto All Poly Tibial component -UHMWPEo Metal Backed Tibial Components:Tibial tray: CoCrMoಂTibial Inserts: UHMWPE0Patellar Component: UHMWPE	Same
Design &Principle ofOperation	Knee joint semi-constrained cementedprosthesisCemented Use Fixed Bearing Design	Same
ndications for	iTotalThe iTotal CR Knee Replacement System(KRS) is 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 Indications for Use include:• Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis or osteonecrosisof the knee.Post traumatic loss of joint function.Moderate varus, valgus or flexiondeformity in which the ligamentousstructures can be returned toadequate function and stability.· Failed osteotomies,hemiarthroplasties, and unicondylar,patellofemoral or bicompartmentalimplants.Revision procedures provided that	Same
Attribute	Predicate Devices	Modified Device(This submission)
	iTotal CR Knee ReplacementSystem (K131467 and K131019) iUni Unicondylar Knee ReplacementSystem (K121974 and K111916) iDuo Bicompartmental Knee RepairSystem (K093513)	iTotal CR Knee ReplacementSystem iUni Unicondylar KneeReplacement System iDuo Bicompartmental KneeRepair System
	anatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scans.This implant is intended for cemented useonly.iUniThe ConforMIS Unicondylar KneeReplacement System (iUni) is intended foruse in one compartment of theosteoarthritic knee to replace the damagedarea of the articular surface in patients withevidence of adequate healthy bonesufficient for support of the implantedcomponents.Candidates for unicondylar kneereplacement include those with: Joint impairment due toosteoarthritis or traumatic arthritisof the knee Previous femoral condyle or tibialplateau fracture, creating loss offunction Valgus or varus deformity of theknee Revision procedures provided thatanatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scans. This implant is intended for cemented useonly.	Same
	iDuoThe ConforMIS iDuo BicompartmentalKnee Repair System is intended for use inpatients with severe knee joint pain anddisability whose conditions cannot be solelyaddressed by the use of a prosthetic device	Same
Attribute	Predicate Devices	Modified Device(This submission)
	iTotal CR Knee ReplacementSystem (K131467 and K131019)iUni Unicondylar Knee ReplacementSystem (K121974 and K111916)iDuo Bicompartmental Knee Repair.System (K093513)that treats only a single knee compartment,such as unicondylar or patellofemoralprosthesis. The indications for use include	iTotal CR Knee ReplacementSystemiUni Unicondylar KneeReplacement SystemiDuo Bicompartmental KneeRepair System
Patient Matchedimplants andinstruments	Yes	Same
Instrumentation	Patient specific Nylon jigs	Same
Packaging	Device components are double-pouchedusing Tyvek®/film pouches which aresealed and labeled	Same
Sterility Method/Assurance Level	VHP Gas Plasma with SAL of 1x10-6	VHP Gas Plasma with SAL of 1x10-6andEthylene oxide with SAL of 1x10-6
Initial Shelf-Life	6 months	Same
Labeled Non-	No	Same

Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization

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K133256 (7/9)

Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization

・

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Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization

{8}------------------------------------------------

. .

iUni Unicondylar Knee Replacestem (K121974 and K11191ninﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ5

eblacementBicc

Description andConclusion ofTesting	Nonclinical Testing: The determination of substantial equivalencefor these devices was based on a detailed device description. Thefollowing non-clinical laboratory testing was performeddemonstrating that the devices are safe and can be consideredsubstantially equivalent to the predicate devices for the intendeduse:Sterilization Validation testing to establish a SAL of 1x10-6 EO residual testing Product and packaging compatibility with ethylene oxidesterilization
Safety andPerformance	The determination of substantial equivalence for these devices wasbased on a detailed device description. Non-clinical laboratorytesting was performed demonstrating that the devices are safe andcan be considered substantially equivalent to the predicate devicesfor the proposed intended use. Clinical data is not necessary todemonstrate substantial equivalence.
Conclusion	Based on the testing conducted it is concluded that the modifieddevices are substantially equivalent to the predicate devices andcan be sterilized to a SAL of 1x10-6 using ethylene oxidesterilization.

Description andConclusion ofTesting

Nonclinical Testing: The determination of substantial equivalencefor these devices was based on a detailed device description. Thefollowing non-clinical laboratory testing was performeddemonstrating that the devices are safe and can be consideredsubstantially equivalent to the predicate devices for the intendeduse:Sterilization Validation testing to establish a SAL of 1x10-6 EO residual testing Product and packaging compatibility with ethylene oxidesterilization

Safety andPerformance

The determination of substantial equivalence for these devices wasbased on a detailed device description. Non-clinical laboratorytesting was performed demonstrating that the devices are safe andcan be considered substantially equivalent to the predicate devicesfor the proposed intended use. Clinical data is not necessary todemonstrate substantial equivalence.

Conclusion

Based on the testing conducted it is concluded that the modifieddevices are substantially equivalent to the predicate devices andcan be sterilized to a SAL of 1x10-6 using ethylene oxidesterilization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

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

January 9, 2014

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

Re: K133256

Trade/Device Name: ConforMIS® iTotal Cruciate Retaining Knee Replacement System (iTotal CR KRS), ConforMIS® iUni Unicondylar Knee Replacement System, ConforMIS® iDuo Bicompartmental Knee Repair System (iDuo KRS)

Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH. HSX, NPJ, OOG Dated: October 22, 2013 Received: October 23, 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

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Page 2 - Ms. Amita S. Shah

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical, device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please 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" (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.

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.

Sincercly yours.

Ronaldillean -S for

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

Enclosure.

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iTotal CR Knee Replacement System

510(k) Number (if known): K133256

Device Name: ConforMIS® Total Cruciate Retaining Knee Replacement System (iTotal CR KRS)

Indications for Use:

. 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

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Page 1 of 3

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey Li Division

Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterilization

{12}------------------------------------------------

iUni Unicondylar Knee Replacement System

510(k) Number (if known): K133256

Device Name: ConforMIS® iUni Unicondylar Knee Replacement System

Indications for Use:

Candidates for unicondylar knee replacement include those with:

· Joint impairment due to osteoarthritis or traumatic arthritis of the knee
AND/OR
Previous femoral condyle or tibial plateau fracture, creating loss of function ●
. Valgus or varus deformity of the knee
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)

Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Page 2 of 3

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterilization

{13}------------------------------------------------

iDuo Bicompartmental Knee Replacement System

510(k) Number (if known): K133256

Device Name: ConforMIS® iDuo Bicompartmental Knee Repair System (iDuo KRS)

Indications for Use:

The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

Painful joint disease due to osteoarthritis .
Traumatic arthritis of the knee. .
Post traumatic loss of joint function .
. Failed osteotomies, hemiarthroplasties, and unicondylar implants.

The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.

The iDuo 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 IF NEEDED)

Page 3 of 3

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterllization

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.