The iTotal PS Knee Replacement System (KRS) 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, polyarthritis or osteonecrosis of the knee.
. Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity.
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.

Device Description

The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate (iTotal CR KRS), ancillary orthopedic manual surgical instruments designed for use with the iTotal PS KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K131467 & K131019. There are only a few differences such as the addition of jigs to guide the bone cutting for the femoral box, the introduction of a full thickness flexion spacer to help assess joint space, and the insert trials that are made to match the tibial insert with the spine feature.

AI/ML Overview

The provided text describes the 510(k) summary for the ConforMIS iTotal Posterior Stabilized Knee Replacement System (iTotal PS KRS). It details the device, its intended use, and the studies conducted to establish its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iTotal PS KRS were not explicitly provided as numerical targets. Instead, the study's goal was to demonstrate substantial equivalence to predicate devices through functional testing. The "reported device performance" is the conclusion that the device's performance in these non-clinical tests was comparable to the predicate devices, thereby meeting the implicit acceptance criteria of being "safe and substantially equivalent."

Acceptance Criteria (Implicit)	Reported Device Performance
Functional equivalence to predicate devices in mechanical and performance tests.	All non-clinical laboratory tests demonstrated that the device is substantially equivalent to the predicate devices and is safe for its intended use.

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

The document details non-clinical laboratory tests, meaning physical and mechanical tests performed on the device components, not on human patients. Therefore, terms like "test set," "country of origin," and "retrospective or prospective" do not directly apply in the typical medical device AI/software context.

Sample Size for Test Set: Not explicitly stated as a number of "samples" in a clinical sense. The tests involve multiple specimens of the device components (e.g., femoral components, tibial trays, inserts) subjected to various mechanical loads and conditions. The specific number of specimens per test is not provided in this summary.
Data Provenance: N/A, as these are non-clinical, laboratory-based tests of physical components, not patient data.

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

N/A. This information is relevant for studies involving human assessment or interpretation (e.g., image review by radiologists). For the mechanical and functional testing described, "experts" in establishing ground truth would refer to engineers and technicians conducting the tests and interpreting the results according to established engineering and regulatory standards, not clinical experts.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (e.g., radiologists) when establishing ground truth from patient data. This is not applicable to the non-clinical laboratory testing described.

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

No. An MRMC comparative effectiveness study involves human readers assessing cases with and without AI assistance to measure the AI's impact on human performance. The studies mentioned here are entirely non-clinical laboratory tests to determine physical and mechanical equivalence, not human-in-the-loop performance studies.

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

The device is a physical knee replacement system and patient-specific surgical instruments, not an AI algorithm. Therefore, "standalone algorithm performance" (without human-in-the-loop) is not applicable.

The closest analogy to "standalone performance" in this context would be the "Software verification and validation testing" mentioned, which assesses the performance of the software used to design the patient-specific implants. However, no details are provided about the outcome or methodology of this software testing other than its inclusion in the list of non-clinical tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering and biomechanical properties, performance characteristics, and material specifications required by the FDA guidance document and by existing predicate devices.

Type of Ground Truth: Engineering and biomechanical standards, material specifications, and performance characteristics (e.g., fatigue life, contact stress, constraint) of predicate devices as set forth in "The FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003."

8. The Sample Size for the Training Set

N/A. This concept is for machine learning models. The device is a physical implant system, not an AI model trained on data. The software used to design the patient-specific implants would likely be developed and validated rather than "trained" in the machine learning sense. The summary provides no information on the development or validation of this software, or any "training set."

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

N/A, for the reasons mentioned in point 8.

Summary

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K140833

6.0 510(K) SUMMARY (PAGE 1 OF 5)

JUN 3 0 2014

Submitter's Name andAddress:	ConforMIS, Inc.28 Crosby DriveBedford, MA 01730
Establishment RegistrationNumber:	3009844603 and 3004153240
Date of Summary:	March 31, 2014
Contact Person:Telephone Number:Fax Number:	Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs(781) 345-9164(781) 345-0147
Name of the Device:	ConforMIS iTotal ® Posterior Stabilized Knee Replacement System(iTotal PS KRS)
Common Name:	Posterior Stabilized Total Knee Replacement System
Regulatory Status andRegulation Number:	Class II21 CFR 888.3560
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis
Device Classification:	Product Code:JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
	OOG: Knee Arthroplasty Implantation System.Intended to be used to assist in the implantation of a specific kneearthroplasty device or a set of specific knee arthroplasty devices.Indicated to include guiding alignment, making or establishing cuts,selecting, sizing, attaching, positioning or orienting implantcomponents.
	OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer + additive/metal/polymer + additive.This generic type of device includes prosthesis that have a femoralcomponent made of alloys, such as cobalt-chromium-molybdenum, anda tibial component(s) and/or a retropatellar resurfacing componentmade of ultra-high molecular weight polyethylene plus an additive, suchas a-tocopherol.

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510(K) SUMMARY (PAGE 2 OF 5)

Indications for Use:

The Indications for Use include:

Painful joint disease due to osteoarthritis, traumatic arthritis, . rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
. Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity. �
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.

ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: ============================================================================================================================================================================== Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K131467 & K131019

DePuy Attune Knee System Device Class: == Product Code: JWH, OIY Regulation Number: 21 CFR 888.3560 510(k) number: K111433

Zimmer Persona Personalized Knee System Device Class: ll Product Code: JWH Regulation Number: 21 CFR 888.3560 510(k) number: K113369

Identification of the Legally Marketed Device (Predicate Device):

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510(K) SUMMARY (PAGE 3 OF 5)

Device Description:

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510(K) SUMMARY (PAGE 4 OF 5)

Substantial Equivalence:

The product subject of this premarket notification is substantially equivalent in design and functionality to the iTotal Cruciate Retaining Knee Replacement System (K131467, cleared July 18, 2013 & K131019, cleared May 24, 2013); the DePuy Attune PS Total Knee System (K111433, cleared August 30, 2011); and the Zimmer Persona PS Personalized Knee System (K113369, cleared March 27, 2012).

Functional testing was conducted in compliance with the FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003.

Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:

Femoral Component Fatigue Testing .
. Tibial Tray Fatigue Testing
Tibial Insert Spine-Femoral Cam Fatigue Testing .
Tibiofemoral Contact Area and Surface Stress Testing .
Patellofemoral Contact Area and Surface Stress Testing .
Patellofemoral Lateral Stability Testing .
Tibiofemoral Constraint Analysis .
Rotational Laxity Testing .
Range of Motion Analysis t
Tibial Interlock Strength Testing .
. Tibial Insert Push-in/ Push-out Testing
Cadaveric Evaluation .
Software verification and validation testing .
. MR Compatibility Testing

All testing has demonstrated that the device is substantially equivalent to the predicate devices.

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· ·

Description andConclusion of Testing:	Nonclinical Testing: The determination of substantial equivalence for thisdevice was based on a detailed device description and non-clinicallaboratory testing. Testing on the iTotal PS Knee Replacement Systemincluded functional testing in compliance with The FDA Guidance Class IISpecial Controls Class II Special Controls Guidance Document: Knee JointPatellofemorotibial and Femorotibial Metal/Polymer Porous-CoatedUncemented Prostheses; Guidance for Industry and FDA, issued January16, 2003.Specifically, the following non-clinical laboratory tests were performed todetermine substantial equivalence:Femoral Component Fatigue Testing Tibial Tray Fatigue Testing Tibial Insert Spine-Femoral Cam Fatigue Testing Tibiofemoral Contact Area and Surface Stress Testing Patellofemoral Contact Area and Surface Stress Testing Patellofemoral Lateral Stability Testing Tibiofemoral Constraint Analysis Rotational Laxity Testing Range of Motion Analysis Tibial Interlock Strength Testing Tibial Insert Push-in/Push-out Testing Cadaveric Evaluation Software verification and validation testing MR Compatibility Testing Test results demonstrated that the device is safe and can be consideredsubstantially equivalent to the predicate devices for the intended use.
Safety andPerformance:	The determination of substantial equivalence for this device was based ona detailed device description and non-clinical laboratory testing. Thetesting demonstrated that the device is safe for its intended use and canbe considered substantially equivalent to the predicate devices. Clinicaldata is not necessary to demonstrate substantial equivalence.
Conclusion:	Based on the testing conducted, it is concluded that the iTotal PosteriorStabilized Knee Replacement System is substantially equivalent to thepredicate devices: the iTotal Cruciate Retaining Knee ReplacementSystem (K131467, cleared July 18, 2013, & K131019, cleared May 24,2013); the DePuy Attune PS Total Knee System (K111433, cleared August30, 2011); and the Zimmer Persona PS Personalized Knee System(K113369, cleared March 27, 2012).

Description andConclusion of Testing:

Nonclinical Testing: The determination of substantial equivalence for thisdevice was based on a detailed device description and non-clinicallaboratory testing. Testing on the iTotal PS Knee Replacement Systemincluded functional testing in compliance with The FDA Guidance Class IISpecial Controls Class II Special Controls Guidance Document: Knee JointPatellofemorotibial and Femorotibial Metal/Polymer Porous-CoatedUncemented Prostheses; Guidance for Industry and FDA, issued January16, 2003.Specifically, the following non-clinical laboratory tests were performed todetermine substantial equivalence:Femoral Component Fatigue Testing Tibial Tray Fatigue Testing Tibial Insert Spine-Femoral Cam Fatigue Testing Tibiofemoral Contact Area and Surface Stress Testing Patellofemoral Contact Area and Surface Stress Testing Patellofemoral Lateral Stability Testing Tibiofemoral Constraint Analysis Rotational Laxity Testing Range of Motion Analysis Tibial Interlock Strength Testing Tibial Insert Push-in/Push-out Testing Cadaveric Evaluation Software verification and validation testing MR Compatibility Testing Test results demonstrated that the device is safe and can be consideredsubstantially equivalent to the predicate devices for the intended use.

Safety andPerformance:

The determination of substantial equivalence for this device was based ona detailed device description and non-clinical laboratory testing. Thetesting demonstrated that the device is safe for its intended use and canbe considered substantially equivalent to the predicate devices. Clinicaldata is not necessary to demonstrate substantial equivalence.

Conclusion:

Based on the testing conducted, it is concluded that the iTotal PosteriorStabilized Knee Replacement System is substantially equivalent to thepredicate devices: the iTotal Cruciate Retaining Knee ReplacementSystem (K131467, cleared July 18, 2013, & K131019, cleared May 24,2013); the DePuy Attune PS Total Knee System (K111433, cleared August30, 2011); and the Zimmer Persona PS Personalized Knee System(K113369, cleared March 27, 2012).

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 0903 New Hamnshire Avenue Document Control Control Conter - WC66-G609 Silver Spring, MI) 20993-0002

June 30, 2014

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

Re: K140833

Trade/Device Name: ConforM1S iTotal* Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS) 、 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OOG. OIY Dated: March 31, 2014 Received: April 2, 2014

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. Ilisting 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

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Page 2 - Ms. Amita Shah

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 Industry and Consumer Education 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. 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. T

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

ﻨﺘﻬﺎ

Sincerely yours,

Lori A. Wiggins

for

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

Enclosure

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K140833

Indications for Use

K140833 510(k) Number (if known): _

Device Name:

ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (ITotal PS KRS)

Indications for Use:

The iTotal PS Knee Replacement System (KRS) 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

Painful joint disease due to osteoarthritis, traumatic arthritis, theumatoid arthritis, polyarthritis . or osteonecrosis of the knee.
. Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity. .
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 Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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

Traditional 510(k) - iTotal PS KRS

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.