The ConforMIS Unicondylar Knee Repair 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 ConforMlS Unicondvlar Knee Repair System (iUni KRS) with curved tibial insert is composed of individually packaged femoral and tibial components. The femoral component is manufactured of cobalt chromium molybdenum (CoCrMo) alloy. The tibial implant is offered in two configurations; an all polymer (UHMWPE) configuration and metal-backed configuration. The Metal-backed Tibial implant consists of two components: a CoCrMo tibial tray and an ultra-high molecular weight polyethylene (UHMWPE) tibial trav insert.

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. In this manner, the implant is personalized on its bone contact and articular surfaces to match a patient's anatomy, thus becoming patient specific.

AI/ML Overview

The provided text is a 510(k) summary for the ConforMIS® Unicondylar Knee Repair System (iUni® KRS). This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing specific performance acceptance criteria and proving them through a new study with a statistical design. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test and training sets, expert qualifications, and detailed study types) is not present in this regulatory document.

However, I can extract information related to the device and its regulatory submission.

Device Description and Purpose:

The ConforMIS Unicondylar Knee Repair System (iUni KRS) with a curved tibial insert is designed to replace damaged articular surfaces in one compartment of an osteoarthritic knee. The device is personalized to the patient's anatomy using proprietary software analysis of MRI or CT scan images. It comprises femoral and tibial components. The femoral component is CoCrMo alloy. The tibial implant comes in two configurations: all UHMWPE or metal-backed (CoCrMo tray with UHMWPE insert).

Substantial Equivalence Claims:

The submission asserts substantial equivalence to existing, legally marketed iUni Unicondylar Knee Repair Systems (reference K043570, K063432, K072368, and K072586).

I. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of explicit acceptance criteria with numerical targets or specific performance metrics derived from a new study designed to prove these criteria. Instead, it relies on a determination of substantial equivalence to predicate devices. The "performance" mentioned is in the context of safety.

Feature/Criterion (Implied)	Reported Device Performance
Safety	Non-clinical laboratory testing was performed demonstrating that the device is safe.
Material Composition	Femoral: Cobalt Chromium Molybdenum (CoCrMo) alloy. Tibial: Ultra-high molecular weight polyethylene (UHMWPE) or CoCrMo tibial tray with UHMWPE insert. (Matches predicate material usage).
Intended Use	For use in one compartment of the osteoarthritic knee to replace damaged articular surface in patients with adequate healthy bone. Candidates: joint impairment due to osteoarthritis/traumatic arthritis, previous femoral condyle/tibial plateau fracture, valgus/varus deformity. (Matches predicate intended use).
Personalization Method	Design derived from analysis of MRI or CT images using proprietary software to match patient's femoral and tibial anatomy. (This is a key characteristic of the iUni system, indicating consistency with previous iUni clearances).
Cemented Use	Intended for cemented use only. (Consistent with predicate).

II. Sample Size Used for the Test Set and Data Provenance:

The document states: "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."

Sample Size for Test Set: Not specified. As this is a 510(k) summary for substantial equivalence, it likely refers to various materials, mechanical, and perhaps wear testing, rather than a clinical "test set" in the sense of patient data.
Data Provenance: Not specified, but "non-clinical laboratory testing" generally implies in-vitro or bench testing, not human subject data.

III. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The submission is based on non-clinical laboratory testing and comparison to predicate devices, not on a study requiring expert-established ground truth on a test set (e.g., for diagnostic accuracy).

IV. Adjudication Method for the Test Set:

Not applicable. No clinical test set with adjudicated ground truth is described.

V. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. This device is a surgical implant, not an imaging AI diagnostic tool, so an MRMC study would be out of scope for this type of submission.

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

Not applicable in the context of a medical device implant. The "proprietary software" is used to design the implant, which is then surgically implanted by a human. There is no "algorithm only" performance metric in this context.

VII. The type of ground truth used:

For the non-clinical testing, the "ground truth" would be established engineering standards, material properties, biomechanical test methods, and potentially wear simulation protocols that are considered acceptable for demonstrating the safety and performance of orthopedic implants.

VIII. The sample size for the training set:

Not applicable. This is not a machine learning submission in the sense of training a diagnostic algorithm on a dataset. The "proprietary software" analyzes individual patient images to design personalized implants, but there's no mention of a "training set" for the software in the context of this 510(k). The clinical data comes from predicate devices.

IX. How the ground truth for the training set was established:

Not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

Ko9a441

SEP 0 Y 2009

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.0 510(k) SUMMARY

Page 1 of 2

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

Submitter's Name and Address:	ConforMIS Inc.2 Fourth Ave.Burlington, MA 01804
Contact Person:	Amita S. ShahDirector, Quality Assurance
Date:	August 7, 2009
Name of Medical Device:	Device Regulation: 21 CFR 888.3520
	Product Code: HSX
	Common/Usual Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
	Proprietary Name: ConforMIS Unicondylar Knee Repair System (iUniKRS)
Device Classification:	In accordance with per 21 CFR 888.3520, a knee joint femorotibialmetal/polymer non-constrained cemented prosthesis is classified by theFDA as a Class II Medical Device.
Indications for Use:	The ConforMIS Unicondylar Knee Repair System (iUni KRS) with curvedtibial insert is intended for use in one compartment of the osteoarthriticknee to replace the damaged area of the articular surface in patientswith evidence of adequate healthy bone sufficient for support of theimplanted components.
	Candidates for unicondylar knee repair include those with:joint impairment due to osteoarthritis or traumatic arthritis of the kneeprevious femoral condyle or tibial plateau fracture, creating loss of function andvalgus or varus deformity of the knee.
	This implant is intended for cemented use only.

{1}------------------------------------------------

510(k) SUMMARY Page 2 of 2

Device Description:

Substantial Equivalence:

The product subject of this premarket notification is substantially equivalent to the currently marketed iUni Unicondvlar Knee Repair System (reference K043570. K063432, K072368 and K072586).

Safety and Performance:

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a bird or a person with outstretched arms, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

SEP 0 Y 2009

ConforMIS. Inc. % Ms. Amita Shah Director, Quality Assurance 2 Fourth Avenue Burlington, Massachusetts 01803

Re: K092441

Trade/Device Name: ConforMIS® iUni® Unicondylar Knee Repair System (iUni KRS) Regulation Number: 21 CFR 888.3520

Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented

prosthesis

Regulatory Class: Class II Product Code: HSX Dated: August 6, 2009 Received: August 10, 2009

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 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.

{3}------------------------------------------------

Page 2 - Ms. Amita Shah

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Me kerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

5.0 INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name: ConforMIS® iUni® Unicondylar Knee Repair System (iUni KRS)

KO424

Indications for Use:

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.

Prescription Use_ × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joutte for mxn
(Division Sign-dit)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092441

Special 510(k) - iUni® KRS - Unicondylar Knee Repair 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.