(128 days)
The iTotal® CR Knee Replacement System 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 or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• 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
The iTotal Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (either CT or MR scans) 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 (CoCr) alloy. The tibial component includes a metal tray manufactured from CoCr alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also 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, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR 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 function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate iTotal CR 510(k)s (K131467, K131019 and K122870).
The provided text is a 510(k) summary for the ConforMIS iTotal® Cruciate Retaining Knee Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and performance against those criteria as would be done for a novel device.
The "study" in this context is a series of non-clinical laboratory tests designed to show that changes to the manufacturing process (specifically, using additive manufacturing for the femoral component) do not negatively impact the device's safety and effectiveness compared to the predicate devices. Therefore, the "acceptance criteria" discussed here are implicitly related to the performance benchmarks set by the predicate devices, and the "reported device performance" is the demonstration that the new device meets those benchmarks through direct testing.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Devices & Regulations) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Material Properties (CoCr alloy) | Material properties tests demonstrated that the device is safe and can be considered substantially equivalent to the predicate device. |
| Mechanical Properties | Mechanical properties testing demonstrated that the device is safe and can be considered substantially equivalent to the predicate device. |
| Biocompatibility | Biocompatibility Testing of implants manufactured by the additive manufacturing process demonstrated that the device is safe and can be considered substantially equivalent. |
| Contact Stress/Area | Contact stress/area testing demonstrated that the device is safe and can be considered substantially equivalent to the predicate device. |
| Fatigue Resistance | Fatigue testing of femoral implant demonstrated that the device is safe and can be considered substantially equivalent to the predicate device. |
| Safety for Intended Use | All testing has demonstrated 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
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (material properties, mechanical properties, biocompatibility, contact stress/area, fatigue). It generally refers to "testing on the femoral components" and "biocompatibility testing of implants."
- Data Provenance: The data is from non-clinical laboratory testing conducted by the submitter (ConforMIS Inc.). The country of origin is not explicitly stated, but it is implied to be internal testing or contracted testing laboratories. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate equivalence of the new manufacturing process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device 510(k) involving non-clinical (laboratory) testing of physical and mechanical properties, not an AI/diagnostic imaging study requiring human expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device 510(k) involving non-clinical (laboratory) testing, not an AI/diagnostic imaging study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) is for a total knee replacement system and relies on non-clinical laboratory testing to demonstrate substantial equivalence, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical knee implant, not an algorithm or AI system for standalone performance evaluation. The "proprietary and off-the-shelf software" mentioned is used for patient-specific implant design, but its performance is not assessed in a standalone capacity in this document; rather, the safety and effectiveness of the resulting physical implant are evaluated through non-clinical tests.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance characteristics and safety profile of the predicate devices (iTotal CR KRS, K131467, K131019, and K122870), as well as general regulatory standards for knee joint prostheses (e.g., ISO standards for material and mechanical testing, biocompatibility standards). The purpose of the testing was to demonstrate that the new device, with its additive manufactured femoral component, meets these established benchmarks and is substantially equivalent.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this 510(k) submission, as it focuses on non-clinical testing of a physical medical device, not the development of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8.
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6.0 510(K) SUMMARY
MAR 2 8 2014
| Submitter's Nameand Address | ConforMIS Inc.28 Crosby DriveBedford, MA 01730 |
|---|---|
| EstablishmentRegistrationNumber | 30041532403009844603 |
| Date of Summary | November 19, 2013 |
| Contact Person | Amita S. Shah, Senior Vice President, Regulatory and Quality Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0147 |
| Name of the Device | ConforMIS iTotal® Cruciate Retaining Knee Replacement System |
| Common or UsualName | Cruciate Retaining Total Knee Replacement System |
| ClassificationName | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis |
| Regulation Number | 21 CFR 888.3560 |
| DeviceClassification | Product Code:JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented,Polymer/Metal/PolymerOIY - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented,Polymer + Additive/Metal/Polymer +AdditiveOOG - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Intended to be used to assist in theimplantation of a specific knee arthroplasty device or a set of specific kneearthroplasty devices. Indicated to include guiding alignment, making orestablishing cuts, selecting, sizing, attaching, positioning or orientingimplant components. |
| 510(k) Summarycontinued | |
| Indications for Use | The iTotal® CR Knee Replacement System is intended for use as a totalknee replacement in patients with knee joint pain and disability whoseconditions cannot be solely addressed by the use of a prosthetic devicethat treats only one or two of the three knee compartments, such as aunicondylar, patellofemoral or bicompartmental prosthesis. |
| The Indications for Use include:• Painful joint disease due to osteoarthritis, traumatic arthritis,rheumatoid arthritis or osteonecrosis of the knee.• Post traumatic loss of joint function.• Moderate varus, valgus or flexion deformity in which theligamentous structures can be returned to adequate functionand stability.• Failed osteotomies, hemiarthroplasties, and unicondylar,patellofemoral or bicompartmental implants.• Revision procedures provided that anatomic landmarksnecessary for alignment and positioning of the implant areidentifiable on patient imaging scans.This implant is intended for cemented use only | |
| Identification of theLegally MarketedDevices(Predicate Devices) | ConforMIS iTotal CR Knee Replacement System (KRS)Device Class: IIProduct Code: JWH, OOG, OIYRegulation Number: 21 CFR 888.3560510(k) number: K131467, K131019, K122870 |
| 510(k) Summarycontinued | |
| Device Description | The iTotal Cruciate Retaining Knee Replacement System (hereafterreferred to as the "iTotal CR KRS") is a patient specific tricompartmentalfaceted posterior cruciate ligament (PCL) retaining knee replacementsystem. The iTotal CR KRS is a semi-constrained cemented knee implantwhich consists of a femoral, tibial and patellar component. |
| Using patient imaging (either CT or MR scans) and a combination ofproprietary and off the shelf software a patient-specific implant is designedthat best meets the geometric and anatomic requirements of the specificpatient. The femoral component is manufactured from cobalt chromiummolybdenum (CoCr) alloy. The tibial component includes a metal traymanufactured from CoCr alloy and either one or two polyethylene inserts.The polyethylene inserts may be manufactured from either UHMWPE or ahighly cross-linked Vitamin E infused polyethylene (iPoly XE™) Thepatellar component is also 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,accessory orthopedic manual surgical instruments designed for use withthe modified iTotal CR KRS are provided to assist with implantation. Theancillary instruments are provided sterile and for single-use only. Thesepatient specific instruments are provided to assist in the positioning of totalknee replacement components intra-operatively and in guiding the cuttingof bone. | |
| The function and general design features of the patient specific ancillaryinstruments remain similar to those described in the predicate iTotal CR510(k)s (K131467, K131019 and K122870). | |
| 510(k) Summarycontinued | |
| SubstantialEquivalence | The product subject of this premarket notification is substantially equivalentin design and functionality to the iTotal Cruciate Retaining KneeReplacement System (K131467 cleared July 18, 2013, K131019 clearedMay 24, 2013, and K122870 cleared January 14, 2013). The proposedfemoral components will be manufactured by an additive manufacturingprocess using CoCr alloy in a powdered form.The following non-clinical laboratory testing was performed to determinesubstantial equivalence:Material properties of CoCr implants manufactured by an additivemanufacturing process Mechanical properties testing Physical properties testing Biocompatibility Testing of implants manufactured by the additivemanufacturing process Performance testing of femoral implants manufactured through theadditive manufacturing process Fatigue testing Contact stress/area testing All testing has demonstrated the device is substantially equivalent to thepredicate devices. |
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510(k) Summary continued: Device Comparison
| Characteristic | iTotal CR KRS with femoral componentmanufactured via an additive manufacturingprocess (This submission) | Predicate iTotal CR KRS (K131467, K131019and K122870) |
|---|---|---|
| Indication for Use | The iTotal® CR Knee Replacement System isintended for use as a total knee replacement inpatients with knee joint pain and disability whoseconditions cannot be solely addressed by the useof a prosthetic device that treats only one or twoof the three knee compartments, such as aunicondylar, patellofemoral or bicompartmentalprosthesis.The indications for use include:Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis or osteonecrosisof the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexiondeformity in which the ligamentousstructures can be returned toadequate function and stability. Failed osteotomies.hemiarthroplasties, and unicondylar,patellofemoral or bicompartmentalimplants. Revision procedures provided thatanatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scans | The iTotal® CR Knee Replacement System isintended for use as a total knee replacement inpatients with knee joint pain and disability whoseconditions cannot be solely addressed by the useof a prosthetic device that treats only one or twoof the three knee compartments, such as aunicondylar, patellofemoral or bicompartmentalprosthesis.The indications for use include:Painful joint disease due toosteoarthritis, traumatic arthritis,rheumatoid arthritis or osteonecrosis ofthe knee. Post traumatic loss of joint function. Moderate varus, valgus or flexiondeformity in which the ligamentousstructures can be returned to adequatefunction and stability. Failed osteotomies,hemiarthroplasties, and unicondylar,patellofemoral or bi-compartmentalimplants. Revision procedures provided thatanatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scans |
| The implant is intended for cemented use only | The implant is intended for cemented use only | |
| Intended forCemented Use Only | Yes | Yes |
| ProductClassification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Design | Knee joint patellofemorotibial semi -constrainedcemented prosthesis | Knee joint patellofemorotibial semi -constrainedcemented prosthesis |
| Tibial Implant | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin Einfused highly cross-linked UHMWPE Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin Einfused highly cross-linked UHMWPE Single or Dual inserts Insert sizes: 6-16mm Profile: patient specific |
| Femoral Implant | CoCr - cast, wrought or additive manufacturing process Patient specific | CoCr - cast or wrought material Patient specific |
| Patella Implant | UHMWPE or Vitamin E infused highly cross-linked UHMWPE | UHMWPE or Vitamin E infused highly cross-linked UHMWPE |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| Principle of Operation | Cemented useFixed Bearing Design | Cemented useFixed Bearing Design |
| Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| Packaging | Device components are individually doublepouched using Tyvek® /film pouches which aresealed and labeled | Device components are individually doublepouched using Tyvek® /film pouches which aresealed and labeled |
| Sterility Method/Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 |
| Initial Shelf-Life | 6 months | 6 months |
| Labeled Non-pyrogenic | No | No |
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| 510(k) Summarycontinued | |
|---|---|
| Description andConclusion ofTesting | The determination of substantial equivalence for this device was basedon a detailed device description and non-clinical laboratory testing.Testing on the femoral components manufactured from an additivemanufacturing process is outlined below:• Material properties tests• Mechanical properties testing• Biocompatibility tests• Contact area/contact stress testing• Fatigue testing of femoral implantTest results demonstrated that the device is safe and can be consideredsubstantially equivalent to the predicate device for the intended use. |
| Safety andPerformance | The determination of substantial equivalence for this device was basedon a 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 CruciateRetaining Knee Replacement System with femoral components madefrom an additive manufacturing process is substantially equivalent to theiTotal Cruciate Retaining Knee Replacement System (K131467,K131019 and K122870) |
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Image /page/7/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is black and the background is white.
March 28, 2014
ConforMIS, Incorporated Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts, USA
Re: K133560
Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG Dated: March 3, 2014 Received: March 4, 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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Amita Shah
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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,
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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Indications for Use
510(k) Number (if known): _K133560
Device Name: iTotal CR Knee Replacement System
Indications for Use:
The iTotal® CR 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 or osteonecrosis of the knee.
- Post traumatic loss of joint function. .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- . 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 | 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 ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE
| Casey L. Hanley, Ph.D |
|---|
| Division of Orthopedic Devices |
Traditional 510(k) - Modified iTotal® CR KRS - Additive manufacturing
§ 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.