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.

Device Description

ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni is comprised of a set of implants designed from patient images. The implant system consist of:

1 Femoral Implant
1 Tibial Component (all-polyethylene or metal backed)

The implants of the iUni KRS will be composed of individually packaged femoral and tibial components and will be provided with ancillary instrumentation to assist in the implantation procedure.

The patient-specific femoral implant will be made of Cobalt Chrome Molybdenum alloy (CoCrMo) and will be personalized to match a patient's anatomy.

The all poly tibial component is made from UHMWPE. The metal backed tibial component will consist of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences.

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) submission for the ConforMIS iUni Unicondylar Knee Replacement System. This submission is for clarifying the indications for use statement and does not involve any changes to the device itself. Therefore, a study to prove device performance relative to acceptance criteria as if it were a new AI/software device is not relevant in this context.

The document explicitly states:

"Non-clinical laboratory testing was not performed as there is no change to the device."
"Clinical data is not necessary to demonstrate substantial equivalence."
"The determination of substantial equivalence for this device was based on the indications for use statements and the device design. The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. A comparison of the designs and the indications for use statements confirmed that the modification to the indications for use does not affect device performance and is, therefore, also substantially equivalent."

This 510(k) is essentially an administrative update to align the indications for use with previous clearances and FDA guidance. There are no performance metrics or detailed studies presented for this particular submission. The "device performance" in question here is the device's substantial equivalence to existing predicate devices based on its design and intended use, not on specific quantitative performance metrics tested in a study for this submission.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not part of this specific 510(k) submission.

However, I can provide information based on the premise of the submission, which is about substantial equivalence, not new performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criterion	Reported Device Performance
Substantial Equivalence	The updated Indications for Use statement and device design must not affect device performance compared to predicate devices, maintaining substantial equivalence.	The ConforMIS iUni Unicondylar Knee Replacement System with the updated indications for use statement is concluded to be substantially equivalent to the iUni Unicondylar Knee Replacement System (K111916, K092441, K072586, K072368, K063432, K043570); Smith & Nephew Journey Unicondylar (K102069); and Zimmer Unicompartmental Knee System (K033363) based on detailed device description and indications for use statement comparisons.
Device Design Comparison	The device design must be consistent with previously cleared devices.	The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. (No changes in design for this submission).
Indications for Use Alignment	The updated indications for use statement must be consistent with predicate devices and FDA guidance.	The purpose of this submission is to clarify the indications for use statement and make it consistent with predicate devices and FDA guidance. (This was the primary goal and was achieved by comparing statements).
Clinical Data Requirement	Clinical data should be unnecessary if substantial equivalence is demonstrated without device change.	Clinical data is not necessary to demonstrate substantial equivalence as there is no change to the device, and the substantial equivalence is based on comparisons of descriptions and indications for use.

2. Sample size used for the test set and the data provenance
Not applicable for this submission. No new test set data was generated or analyzed as there was no change to the device. The evaluation was based on a comparison of device descriptions and indications for use statements against existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this submission. No new ground truth was established as there was no study for device performance.

4. Adjudication method for the test set
Not applicable for this submission.

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
Not applicable for this submission. This device is a physical knee replacement system, not an AI/software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for this submission. This device is a physical knee replacement system, not an algorithm.

7. The type of ground truth used
Not applicable for this submission. The "ground truth" for this 510(k) was the existing regulatory clearances and indication statements of the predicate devices.

8. The sample size for the training set
Not applicable for this submission.

9. How the ground truth for the training set was established
Not applicable for this submission.

Summary

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

K121974 (1/4)

SEP 6 2012

5.0 510(K) SUMMARY (page 1 of 4)

・・ .

Submitter's Name and Address	ConforMIS Inc.11 North Ave.Burlington, MA 01803
Establishment Registration Number	3004153240 and 3008690421
Date of Summary	July 03, 2012
Contact Person	Amita S. Shah, Vice President, Quality Assurance and Regulatory Affairs
Telephone Number	(781) 345-9164
Fax Number	(781) 345-0104
Name of the Device	ConforMIS iUni Unicondylar Knee Replacement System
Common or Usual Name	Unicondylar Knee Replacement System
Classification Name	Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymerKnee Arthroplasty Implantation System
Regulation Number	21 CFR 888.3520
Device Classification	Product Code:HSX - Knee joint femorotibial metal/polymer non-constrained cemented prosthesisOOG - 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,

implant components.

selecting, sizing, attaching, positioning or orienting

ન 8

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

510(K) SUMMARY (page 2 of 4)

Indications for Use

Indications for Use:

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,
valqus 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.

ldentification of the Legally Marketed Device (Predicate Device)

ConforMIS iUni Unicondylar Knee Replacement System Device Class: Product Code: HSX, OOG . Regulation Number: 21 CFR 888.3520 510(k) number: K111916, K092441, K072586, K072368, K063432, K043570

Smith & Nephew Journey Unicondylar Device Class: ll Product Code: HSX Regulation Number: 21 CFR 888.3520 K102069 510(k) number:

Zimmer Unicompartmental Knee System Device Class: Product Code: HSX Regulation Number: 21 CFR 888.3520 510(k) number: K033363

ન છ

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

510(K) SUMMARY (page 3 of 4)

Device Description

Substantial Equivalence: ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni is comprised of a set of implants designed from patient images. The implant system consist of:

1 Femoral Implant .
1 Tibial Component (all-polyethylene or metal backed)

The implants of the iUni KRS will be composed of individually packaged femoral and tibial components and will be provided with ancillary instrumentation to assist in the implantation procedure.

The patient-specific femoral implant will be made of Cobalt Chrome Molybdenum alloy (CoCrMo) and will be personalized to match a patient's anatomy.

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

The product subject of this premarket notification is substantially equivalent to the iUni Unicondylar Knee Replacement System (K111916 cleared September 29, 2011, K092441 cleared September 09, 2009, K072586 cleared November 08, 2007, K072368 cleared September 20, 2007, K063432 cleared March 16, 2007, and K043570 cleared March 14, 2005); Smith & Nephew Journey Unicondylar (K102069 cleared October 05, 2010); and Zimmer Unicompartmental Knee System (K033363 cleared January 16, 2004).

The purpose of this submission is to clarify the indications for use statement and make it consistent with predicate devices and FDA guidance.

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

510(K) SUMMARY (page 4 of 4)

Description and Conclusion of Testing The determination of substantial equivalence for this device was based on the indications for use statements and the device design. The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. A comparison of the designs and the indications for use statements confirmed that the modification to the indications for use does not affect device performance and is, therefore, also substantially equivalent.

Safety and Performance

Conclusion

The determination of substantial equivalence for this device was based on detailed device description and indications for use statement comparisons. Non-clinical laboratory testing was not performed as there is no change to the device. Clinical data is not necessary to demonstrate substantial equivalence.

Based on device description and indications for use statement comparisons, it is concluded that the ConforMIS iUni Unicondylar Knee Replacement System with the updated indications for use statement is substantially . equivalent to the iUni Unicondylar Knee Replacement System (K111916 cleared September 29, 2011, K092441 cleared September 09, 2009, K072586 cleared November 08, 2007, K072368 cleared September 20, 2007, K063432 cleared March 16, 2007, and K043570 cleared March 14, 2005); Smith & Nephew Journey Unicondylar (K102069 cleared October 05, 2010); and Zimmer Unicompartmental Knee System (K033363 cleared January 16, 2004)

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

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Conformis, Incorporated % Ms. Amita S. Shah Vice President, Quality Assurance and Regulatory Affairs 11 North Ave Burlington, Massachusetts 01803

SEP 6 2012

Re: K121974

Trade/Device Name: ConforMIS® Unicondylar Knee Replacement System (iUni) 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: July 3, 2012 Received: July 9, 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

{5}------------------------------------------------

Page 2 - Ms. Amita S. 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/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/Resourcesfor You/Industry/deffault.htm

Sincerely yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): _

Device Name:

ConforMIS® Unicondylar Knee Replacement System (iUni)

Indications for Use:

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.

Prescription Use X
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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) mxm ditional 510(k) - Conformis Tom KRS - Clarification of Indications For Use Statement 17

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.