The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with curved tibial insert 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 repair 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 and
• valgus or varus deformity of the knee.

This implant is intended for cemented use only.

Device Description

The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of

1 Femoral Implant .
1 Tibial Trav o
2 or 3 Tibial Inserts 0

The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.

The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.

The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.

The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan.

Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System

AI/ML Overview

The provided text describes a 510(k) summary for the ConforMIS® iUni Unicondylar Knee Replacement System. This submission is for a medical device (knee implant), not an AI/ML-driven device or study assessing algorithm performance. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the provided text, along with indications where the requested information is not available or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (if available)	Reported Device Performance
Safety & Performance Equivalence	To demonstrate substantial equivalence to predicate devices (K043570, K063432, K072368, K072586, K092441) and other marketed cemented unicondylar knee replacement systems.	Non-clinical laboratory testing (Femoral Fatigue, Femoral Implant fixation, Cadaveric testing, Software validation testing) demonstrated the device is safe and substantially equivalent for its proposed intended use.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable for a non-clinical device submission. The "test set" here refers to components used in non-clinical lab testing. Specific numbers for units tested are not detailed in the summary.
Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests performed are described as "Femoral Fatigue," "Femoral Implant fixation," "Cadaveric testing," and "Software validation testing." These are laboratory-based tests, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to human-labeled data. This submission describes physical device testing and software validation, not interpretation of data by experts to establish a "ground truth."
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of data, which is not relevant to the non-clinical lab tests described.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which this is not.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is a physical knee implant. While it uses proprietary software for design based on patient images, "standalone performance" in the context of an algorithm refers to its diagnostic or predictive capability without human intervention. The software here is a design tool, not a diagnostic algorithm. Software validation testing was performed to support changes, but this is validation of the software's ability to correctly design implants, not a "standalone performance" as in AI/ML.

7. The type of ground truth used

Type of Ground Truth: For the non-clinical tests (femoral fatigue, fixation, cadaveric), the "ground truth" would be engineering specifications, biomechanical expectations, and potentially anatomical landmarks from cadaveric studies. For software validation, the "ground truth" would be the expected output or design parameters based on input images. This is not "expert consensus, pathology, or outcomes data" as typically understood in AI/ML.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This device is a physical implant designed using proprietary software, not an AI/ML model trained on a dataset. The software is used to design personalized implants from patient images, implying it's an image processing and design tool, not a learning algorithm that undergoes a training phase in the AI sense.

9. How the ground truth for the training set was established

How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The software's accuracy in generating designs from patient images would typically be validated against known anatomical models or expert-reviewed designs, but this is part of software validation, not AI/ML training ground truth.

Summary

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K111916 (1/2)

SEP 2 9 2011

7.0 510(k) SUMMARY

Page 1 of 2

This 510(k) Summary for the ConforMIS® iUni Unicondylar Knee Replacement System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Nameand Address:	ConforMIS Inc.11 North Ave.Burlington, MA 01804
Contact Person:	Amita S. ShahVice President, Quality and Regulatory Affairs
Date:	July 1, 2011
Name of MedicalDevice:	Device Regulation: 21 CFR 888.3520, 21CFR 888.3560Product Code:HSX, Knee joint femorotibial metal/polymer non-constrained cementedprosthesis.OOG, Knee joint patellofemerotibial polymer/metal/polymer semi-constrained cemented prosthesis.Common/Usual Name: Unicondylar Knee Replacement SystemProprietary Name: ConforMIS iUni Unicondylar Knee ReplacementSystem (iUni KRS)In accordance with 21 CFR 888.3520, a knee joint femorotibial
DeviceClassification:	metal/polymer non-constrained cemented prosthesis is classified by theFDA as a Class II Medical Device.
Indications for Use:	The ConforMIS Unicondylar Knee Replacement System (iUni KRS) withcurved tibial insert is intended for use in one compartment of theosteoarthritic knee to replace the damaged area of the articular surfacein patients with evidence of adequate healthy bone sufficient for supportof the implanted components.
	Candidates for unicondylar knee repair include those with:• joint impairment due to osteoarthritis or traumatic arthritis of theknee• previous femoral condyle or tibial plateau fracture, creating lossof function and• valgus or varus deformity of the knee.
	This implant is intended for cemented use only.

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K111916(²/₂)

510(k) SUMMARY Page 2 of 2

Device Description: The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of

1 Femoral Implant .
1 Tibial Trav o
2 or 3 Tibial Inserts 0

The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.

The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.

The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.

Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System

Substantial Equivalence:

Safety and

Performance:

The product subject of this premarket notification is substantially equivalent to the currently marketed iUni Unicondylar Knee Repair System (reference K043570, K063432, K072368, K072586 and K092441) and other currently marketed; cemented unicondylar knee replacement systems. The following testing was performed to establish substantial equivalence:

Femoral Fatigue .
Femoral Implant fixation �
Cadaveric testing .

. Software validation testing to support changes to the iUni KRS The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use. Clinical data is not necessary to demonstrate substantial equivalence.

Software validation testing to support changes to the iUni KR
The determination of substantial equivalence for this device was bas
on a detailed device description. Non-clinical laboratory testing was
performed demonstrating that the device is safe and can be conside
substantially equivalent to the predicate device for the proposed
intended use. Clinical data is not necessary to demonstrate substant
equivalence.

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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines extending above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is vertically oriented and wraps around the left side of the emblem.

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

Conformis, Inc. % Ms. Amita Shah Vice President, Quality Assurance and Regulatory Affairs l l North Avenue Burlington, Massachusetts 01803

SEP 2 9 2011

Re: K111916

Trade/Device Name: ConforMIS® iUni Unicondylar Knee Replacement System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX. OOG Dated: July 1, 2011 Received: July 6, 2011

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.

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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CFR Part 807); labeling (21 CFR Part 801); medical device 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.

ff 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric Keith

S/ 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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6.0 INDICATION FOR USE STATEMENT

KI11916 510(k) Number (if known):

Device Name: ConforMIS® iUni Unicondylar Knee Replacement System

Indications for Use:

Candidates for unicondylar knee repair include those with:

o joint impairment due to osteoarthritis or traumatic arthritis of the knee
� previous femoral condyle or tibial plateau fracture, creating loss of function and
valgus or varus deformity of the knee. .

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 ANQTHER PAGE IF NEEDED)

Division Sign Off

Division of C. gical, Orthopedic, Concurrence of CDRH, Office of Device Evaluation (ODE

510(k) Number K111916

Special 510(k) – Modified iUniv Unicondylar G2+ Knee Replacement System

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.