(85 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. The implant is intended for cemented use only.
The iTotal CR 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. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patientspecific implant and related instrumentation are designed, that best meet 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 either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE 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 of the cutting of bone.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ConforMIS iTotal CR Knee Replacement System:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria for the device's performance in a clinical or analytical study. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.
The "acceptance criteria" here are implicitly that the modified device performs similarly to or no worse than the predicate devices across various characteristics. The "reported device performance" is a confirmation that these characteristics are maintained or improved.
| Characteristic / Acceptance Criteria | Reported Device Performance (Modified Device vs. Predicate) |
|---|---|
| Indications for Use: Identical to predicate. | Identical to predicate. |
| Intended for Cement Use Only: Yes | Yes |
| Product Classification: Identical to predicate (21 CFR 888.3560 (JWH)). | Identical to predicate. |
| Components: Identical (Femoral, Metal Backed Tibial, Patellar). | Identical. |
| Materials: Identical (Femoral: CoCrMo; Tibial Tray: CoCrMo; Tibial Inserts: UHMWPE; Patellar: UHMWPE). | Identical. |
| Design: Identical (Knee joint patellofemorotibial semi-constrained cemented prosthesis). | Identical. |
| Principle of Operation: Identical (Cemented Use fixed Bearing Design). | Identical. |
| Patient Matched: Yes | Yes |
| Posterior Cruciate Ligament (PCL) Sparing: Yes | Yes |
| Instrumentation: Identical (Patient-specific Nylon jigs). | Identical. |
| Proprietary Software for Femoral Components: Upgrade from v3.0 to v4.0. | iTotalWorks version 4.0 |
| Proprietary Software for Tibial Components: Introduction of iTotalTib v1.0 (previously manual). | iTotalTib version 1.0 or manual process |
| Software Functionality: Software verification and validation testing for iTotalWorks v4.0 and iTotalTib v1.0. | Testing performed, demonstrating safety and substantial equivalence. |
| Non-clinical Laboratory Testing: Demonstrates safety and substantial equivalence. | Testing performed, demonstrating safety and substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- The submission does not mention a traditional "test set" in the context of clinical or analytical performance data from patient samples. The substantial equivalence is primarily based on device description, materials, design, and software verification/validation.
- Data Provenance: Not applicable in the sense of clinical patient data, as the study relies on software testing and device characteristic comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This submission focuses on validating software and demonstrating equivalent physical/design characteristics to a predicate device, rather than assessing a device's diagnostic or clinical performance against expert-established ground truth from patient data.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring expert adjudication is described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data is not necessary to demonstrate substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While not a standalone clinical performance study, the submission does refer to "Software verification and validation testing of proprietary software iTotalWorks" and "Software verification and validation testing of proprietary software iTotalTib." This testing confirms the functionality and accuracy of the algorithms as they relate to the design and manufacturing of the patient-specific implants and instruments. This can be considered a form of standalone software validation, demonstrating the algorithm's performance in its specific intended function (designing the implant and instrumentation based on patient imaging).
7. The Type of Ground Truth Used:
- For the software verification and validation, the ground truth would have been established through design specifications, requirements documents, and potentially comparison to known good outputs or established engineering principles and measurements. For example, the software would be validated to ensure it accurately translates imaging data into the geometric specifications for the patient-specific implants and instruments within specified tolerances.
8. The Sample Size for the Training Set:
- Not applicable. The document does not describe a machine learning model that would require a "training set" in the typical sense of AI/ML-based diagnostic devices. The proprietary software mentioned (iTotalWorks and iTotalTib) likely refers to CAD/CAM software used for design and manufacturing, which does not typically undergo "training" with patient data in the same way an AI diagnostic algorithm would.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. (See point 8).
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5.0 510(K) SUMMARY (PAGE 1 OF 5)
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DEC 2 0 2012
| Submitter's Name andAddress: | ConforMIS Inc.11 North AvenueBurlington, MA 01803 |
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| EstablishmentRegistration Number: | 3004153240 |
| Date of Summary: | September 24, 2012 |
| Contact Person:Telephone Number:Fax Number: | Amita S. Shah, Vice President, Regulatory and Quality Affairs(781) 345-9164(781) 345-0104 |
| Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or UsualName: | Cruciate Retaining Total Knee ReplacementSystem |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Indications for Use: | The iTotal® CR Knee Replacement System (KRS) is intendedfor use as a total knee replacement in patients with knee jointpain and disability whose conditions cannot be solelyaddressed by the use of a prosthetic device that treats only oneor two of the three knee compartments, such as a unicondylar,patellofemoral or bicompartmental prosthesis. The Indicationsfor Use include:Painful joint disease due to osteoarthritis, traumaticarthritis, 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 adequatefunction and stability. Failed osteotomies, hemiarthroplasties, and unicondylar,patellofemoral or bicompartmental implants. The implant is intended for cemented use only. |
| Identification of theLegally MarketedDevice(Predicate Device): | ConforMIS iTotal CR Knee Replacement System (KRS)Device Class: IIProduct Code: JWH, OOGRegulation Number: 21 CFR 888.3560510(k) Number: K094050, K103117, K112780, K113378,K120068, and K120316 |
Traditional 510(k) — Modified iTotal® CR Knee Replacement System — lTotalTib v1.0/iTotalWorks v4.0
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510(K) SUMMARY (PAGE 2 OF 5)
Device Description:
The iTotal CR 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. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patientspecific implant and related instrumentation are designed, that best meet 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 either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE
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 of the cutting of bone.
The function and general design features of the patient-specific ancillary instruments remain similar to those described in the predicate 510k notifications i.e. K094050, K103117, K112780, K113378, K120068, and K120316
The product subject of this premarket notification is substantially equivalent to the Total Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 07, 2011, K112780 cleared December 15, 2011, K113378 cleared February 15, 2012, K120068 cleared February 03, 2012, and K120316 cleared April 19, 2012. The following testing was performed to establish substantial equivalence:
- Software verification and validation testing of . proprietary software
Substantial
Equivalence:
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510(K) SUMMARY (PAGE 3 OF 5)
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Device Comparison
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| Characteristic | PredicateiTotal CR Knee ReplacementSystem(K112780 & K120316) | Modified DeviceiTotal CR Knee ReplacementSystem(This submission) |
|---|---|---|
| Indication forUse | The iTotal® CR Knee ReplacementSystem is intended for use as atotal knee replacement in patientswith knee joint pain and disabilitywhose conditions cannot be solelyaddressed by the use of aprosthetic device that treats onlyone or two of the three kneecompartments, such as aunicondylar, patellofemoral orbicompartmental prosthesis. Theindications for use include:• Painful joint disease due toosteoarthritis, traumaticarthritis, rheumatoidarthritis or osteonecrosis ofthe knee.• Post traumatic loss of jointfunction.• Moderate varus, valgus orflexion deformity in whichthe ligamentous structurescan be returned toadequate function andstability.• Failed osteotomies,hemiarthroplasties, andunicondylar, patellofemoralor bicompartmentalimplants. | The iTotal® CR Knee ReplacementSystem is intended for use as atotal knee replacement in patientswith knee joint pain and disabilitywhose conditions cannot be solelyaddressed by the use of aprosthetic device that treats onlyone or two of the three kneecompartments, such as aunicondylar, patellofemoral orbicompartmental prosthesis. Theindications for use include:• Painful joint disease due toosteoarthritis, traumaticarthritis, rheumatoidarthritis or osteonecrosis ofthe knee.• Post traumatic loss of jointfunction.• Moderate varus, valgus orflexion deformity in whichthe ligamentous structurescan be returned toadequate function andstability.• Failed osteotomies,hemiarthroplasties, andunicondylar, patellofemoralor bicompartmentalimplants. |
| The iTotal KRS is intended forcemented use only | The implant is intended forcemented use only | |
| Intended forCement UseOnly | Yes | Yes |
| ProductClassification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Components | • Femoral Component• Metal Backed TibialComponent• Patellar component | • Femoral Component• Metal Backed TibialComponent• Patellar component |
| Characteristic | PredicateiTotal CR Knee ReplacementSystem(K112780 & K120316) | Modified DeviceiTotal CR Knee ReplacementSystem(This submission) |
| Materials | Femoral Implant: CoCrMoMetal Backed TibialComponents:Tibial tray: CoCrMo Tibial Inserts:UHMWPE All Polymer PatellarComponent: UHMWPE | Femoral Implant: CoCrMoMetal Backed TibialComponents:Tibial tray: CoCrMo Tibial Inserts:UHMWPE All Polymer PatellarComponent: UHMWPE |
| Design | Knee joint patellofemorotibial semi-constrained cemented prosthesis | Knee joint patellofemorotibial semi-constrained cemented prosthesis |
| Principle ofOperation | Cemented Use fixed BearingDesign | Cemented Use fixed BearingDesign |
| PatientMatched | Yes | Yes |
| PosteriorCruciateLigament (PCL)Sparing | Yes | Yes |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| ProprietarySoftware forFemoralComponents | iTotalWorks version 3.0 | iTotalWorks version 4.0 |
| ProprietarySoftware forTibialComponents | N/A - manual process | iTotalTib version 1.0 or manualprocess |
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K122991
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510(K) SUMMARY (PAGE 4 OF 5)
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510(K) SUMMARY (PAGE 5 OF 5)
| Description ofTesting: | Nonclinical Testing: The determination of substantialequivalence for this device was based on a detailed devicedescription. The following non-clinical laboratory testing wasperformed demonstrating that the device is safe and can beconsidered substantially equivalent to the predicate device forthe intended use:Detailed software description and software verificationand validation testing of proprietary softwareiTotalWorks Detailed software description and software verificationand validation testing of proprietary software iTotalTib |
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| Safety andPerformance: | The determination of substantial equivalence for this device wasbased on a detailed device description. Non-clinical laboratorytesting was performed demonstrating that the device is safe andcan be considered substantially equivalent to the predicatedevice for the intended use. Clinical data is not necessary todemonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iTotalCruciate Retaining Knee Replacement System with the use ofthe iTotalWorks v4.0 and iTotalTib v1.0 production software issubstantially equivalent to the iTotal Cruciate Retaining KneeReplacement System (K094050 cleared September 16, 2010,K103117 cleared January 07, 2011 and K112780 cleared Dec15, 2011, K113378 cleared February 15, 2012, K120068cleared February 03, 2012, and K120316 cleared April 19,2012) |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 20, 2012.
ConforMIS, Incorporated % Ms. Amita S. Shah Vice President, Regulatory and Quality Affairs 11 North Avenue Burlington, Massachusetts 01803
Re: K122991
Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
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, OOG Dated: September 24, 2012 Received: September 26, 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
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Page 2 - Ms. Amita S. Shah
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.
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/default.htm.
Sincerely yours,
Mark N. Melkerson
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): K122991
Device Name:
ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Indications for Use:
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, ucy 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.
The 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi
Division of Orthopedic Devices
§ 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.