The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, in patients with:

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

The ConforMIS metal backed tibial component is intended only for use with bone cement

Device Description

The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar | Knee Repair System or the ConforMIS BiCompartmental Knee Repair System to provide the surgeon with an alternative tibial component in the event that he/she prefers to use a metal backed component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint") are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee.

AI/ML Overview

This 510(k) summary (K063432) for the ConforMIS Metal Backed Tibial Component (mBT) does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance evaluations of novel devices. Instead, it relies on substantial equivalence to predicate devices and prior testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Metal Backed Tibial Component itself as it is a modification of an existing system. The "performance" described is about its substantial equivalence.

Criteria	Reported Device Performance
Safety and Effectiveness	"Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate further devices, confirming substantial equivalence."
Design	"The ConforMIS Metal Backed Tibial Component substantially equivalent to is the tibial components cleared for the ConforMiS Unicondylar and BiCompartmental Knee Repair Systems in the is use of imaging data to design a patient-matched implant geometry, as well terms of design and production process, as well as materials and indications. It is substantially equivalent to the cited predicate devices in terms of design, materials, mechanical safety and intended use. All are intended for cemented use only."
Material Composition	Consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. Stated to be substantially equivalent to predicate devices in terms of materials.
Function/Intended Use	Intended for use with ConforMIS Unicondylar Knee Repair System and BiCompartmental Knee Repair Systems for specific knee conditions (osteoarthritis, traumatic arthritis, fracture, valgus/varus deformity). Intended for cemented use only. Stated to be substantially equivalent to predicate devices in function and intended use.
Mechanical Safety	Stated to be substantially equivalent to predicate devices in terms of mechanical safety.
New Safety or Effectiveness Issues	"the ConforMIS Metal Backed Tibial Component raises no new safety or effectiveness issues."

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

The document does not provide information on a specific "test set" for the Metal Backed Tibial Component. The testing mentioned refers to "design verification procedures for the ConforMIS Unicondylar Knee System." No details on sample size or data provenance (country, retrospective/prospective) for those verification procedures are included in this summary.

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

This information is not provided in the document. The submission focuses on engineering and material equivalence, not clinical decision-making validated by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This submission is for a knee implant component, and such studies are typically associated with imaging devices or diagnostic algorithms.

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

This question is not applicable as the device is a physical knee implant component, not an algorithm or software. Its performance is inherent in its physical properties and design when implanted, not standalone algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering and performance characteristics deemed acceptable for existing, legally marketed predicate devices. The substantial equivalence argument relies on the new device having similar design, materials, and function such that its performance is expected to be equivalent to devices already proven safe and effective. It explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this traditional medical device submission. "Training sets" are relevant for AI/ML algorithms, not for the design and testing of a knee implant component.

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

This question is not applicable as there is no "training set" in the context of this device submission.

Summary

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K06 3432

SECTION 2 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of the 510(k) premarket notification for the ConforMIS, Inc. Unicondylar Knee Repair System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

MAR 16 2007

1/4

Summary of Safety and Effectiveness

Submitted By:	ConforMIS, Inc.323 C Vintage Park DriveFoster City, CA 94404Phone 650-286-4151
Contact Person:	S. Michael Sharp, PhDSr. Vice President, Regulatory/Clinical & Quality
Date:	November 10, 2006
Trade/Proprietary Name	Metal Backed Tibial Component ("mBT")
Common Name	Metal/polyethylene tibial component
Classification Name	21 CFR 888.3520 - Knee joint femorotibialmetal/polymer non-constrained cementedprosthesis
Device Class	Class II
Product Code	HSX

CONFIDENTIAL

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K66 3432 2/4

Predicate Devices

Technological Characteristics	Design	Indications for Use
ConforMIS UniCondylarKnee Repair System(K043570)	DePuy PreservationUnicondylar Knee(K040268)	ConforMIS UniCondylarKnee Repair System(K043570)
ConforMISBiCompartmentalKnee Repair System(K053488)	Link Endo-Model SledUni-Knee(K954186)	ConforMISBiCompartmentalKnee Repair System(K053488)
		DePuy PreservationUnicondylar Knee(K040268)
		Link Endo-Model SledUni-Knee(K954186)

Intended Use:

The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, in patients with:

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

The ConforMIS metal backed tibial component is intended only for use with bone cement

Device Description

ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL

November 10 2006

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K063432 3/4

as possible based on images (MRI or CT scan) of the patient's knee.

Comparison to Predicates

The ConforMIS Metal Backed Tibial Component substantially equivalent to is the tibial components cleared for the ConforMiS Unicondylar and BiCompartmental Knee Repair Systems in the is use of imaging data to design a patient-matched implant geometry, as well terms of design and production process, as well as materials and indications. It is substantially equivalent to the cited predicate devices in terms of design, materials, mechanical safety and intended use. All are intended for cemented use only.

Performance Data

Non-clinical Performance and Conclusions:

Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate further devices. confirming substantial equivalence.

Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence.

SUMMARY

Based on the similarities in design, materials, function, and intended use the ConforMIS Metal Backed Tibial Component is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS Metal Backed Tibial Component raises no new safety or effectiveness issues.

USE OF THE TERM "SUBSTANTIAL EQUIVALENCE"

The term "Substantial Equivalence" is used in this submission within the confines of the statutory use in the FDA's evaluation of a Pre-Market Notification Submission. Any statement regarding Substantial Equivalence used in this submission relates only to whether the device that is the subject of this submission may be lawfully marketed in the United States without pre-market approval or reclassification, and should not be interpreted as an admission, or any kind or type of evidence, in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office.

CONFIDENTIAL

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4/4 K063432

The present submission and statements therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in the submission, or its use, may be considered indistinct, from a patentability perspective, from any other device referred to in this sub mission.

ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL

000003 510(k) Submission November 10, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is composed of thick, curved lines that give it a modern and abstract appearance. The text is in a simple, sans-serif font.

MAR 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConforMIS, Inc % S. Michael Sharp, PhD Senior Vice President Regulatory and Clinical Affairs 323-C Vintage Park Drive Foster City, California 94404

Re: K063432

Trade/Device Name: Metal Backed Tibial Component Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 12, 2007 Received: February 13, 2007

Dear Dr. Sharp:

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 such 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); 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.

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Page 2 - Mr. S. Michael Sharp, PhD

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Barbara Buchm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K 06 24(32

Device Name: ConforMIS Metal Backed Tibial Component (mBT)

Indications for Use:

STATEMENT OF INDICATIONS FOR USE

The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, in patients with:

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

The ConforMIS metal backed tibial component is intended only for use with bone cement

Prescription Use ___________________________________________________________________________________________________________(Part 21 CFR 801 Su (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-

CONTINUE ON ANOTHER PAGE IF NEEDED)

Barbara Boccum

(Division Sch-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K063432

000003

ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL

510(k) Submission November 10, 2006

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.