(61 days)
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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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 aligmment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
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 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® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.
Using patient imaging 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 either single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, 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 KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile or non-sterile to be sterilized by the end-user and are for single-use only.
The purpose of this submission is to propose dimensional modifications to the iTotal KRS implants and changes to the ancillary instrumentation.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K142161, K142404 and K152704.
The provided text describes a 510(k) submission for the ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System. This submission focuses on demonstrting substantial equivalence to predicate devices through non-clinical testing, rather than studies that generate new clinical performance data with acceptance criteria that would typically be reported for software products.
Therefore, the following information cannot be extracted from the provided text: acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, expert qualifications, adjudication method, MRMC study effect size, standalone algorithm performance, ground truth type for test set, sample size for training set, and how ground truth for the training set was established.
Here's the information that can be extracted regarding the comparison and testing performed:
1. A table of acceptance criteria and the reported device performance:
No specific numerical acceptance criteria or device performance metrics in terms of clinical outcomes are reported in the provided document. The submission focuses on demonstrating substantial equivalence through non-clinical testing.
2. Sample size used for the test set and the data provenance:
Not applicable. The reported tests are non-clinical laboratory tests, not tests on a clinical dataset with a "test set" in the context of AI/software performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of expert review for clinical data, is not mentioned for these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used for establishing ground truth from expert reviews of clinical data, which is not described here.
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:
No. An MRMC comparative effectiveness study was not performed or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a knee replacement system, not an AI algorithm. The performance evaluation is based on the physical device's characteristics and its comparison to predicate devices, not algorithm-only performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of clinical ground truth. The evaluation is based on engineering principles and performance testing against established standards or predicate device characteristics.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML system that utilizes training sets.
9. How the ground truth for the training set was established:
Not applicable. See above.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described for this 510(k) submission):
The device, ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System, underwent non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices (ConforMIS iTotal CR Knee Replacement System K142161, K142404, K152704 and ConforMIS iTotal PS Knee Replacement System K142161, K142404, K152704).
The study involved the following non-clinical laboratory tests:
- Tibial Insert Spine-Femoral Cam Fatigue Testing: This test likely evaluates the durability and resistance to wear and tear of the tibial insert component under repeated stress, simulating physiological loading conditions.
- Range of Motion Analysis: This test would assess the range of movement permitted by the knee replacement system, ensuring it allows for an appropriate and functional range of motion for the patient.
- Cadaveric Evaluation: This type of evaluation uses cadaveric specimens to assess the device's fit, alignment, and potentially the surgical procedure in a simulated anatomical environment.
The conclusion drawn from these tests was that the present device is substantially equivalent to the predicate devices for their intended use. This implies that the performance in these non-clinical tests met the established performance characteristics or standards for the predicate devices, thereby demonstrating that the modified device is as safe and effective as the previously cleared devices. Clinical data was deemed not necessary to demonstrate substantial equivalence for this submission.
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Image /page/0/Picture/1 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 image of three human profiles facing to the right, stacked on top of each other.
March 7, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ConforMIS, Incorporated Ms. Amita Shah Sr. Vice President, Regulatory and Quality Affairs 28 Crosbv Drive Bedford, Massachusetts 01730
Re: K160025
Trade/Device Name: ConforMIS iTotal Cruciate Retaining Knee Replacement System, ConforMIS iTotal Posterior Stabilized 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, OOG, OIY Dated: February 11, 2016 Received: February 16, 2016
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 Parts 801); medical device reporting (reporting of medical
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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/Resourcesfor You/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 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.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
ConforMIS iTotal Cruciate Retaining Knee Replacement System
Indications for Use (Describe)
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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
- · Post traumatic loss of joint function.
- · Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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 aligmment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ConforMIS iTotal Posterior Stabilized Knee Replacement System
Indications for Use (Describe)
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, traumatoid 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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8.0 510(K) SUMMARY (PAGE 1 OF 4)
| Submitter's Name andAddress: | ConforMIS, Inc.28 Crosby DriveBedford, MA 01730 |
|---|---|
| Establishment RegistrationNumber: | 3009844603 and 3004153240 |
| Date of Summary: | January 5, 2016 |
| 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(s): | ConforMIS iTotal® Cruciate Retaining Knee Replacement System (iTotalCR KRS)ConforMIS iTotal® Posterior Stabilized Knee Replacement System(iTotal PS KRS) |
| Common Name(s): | 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 Codes: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 implant components. | |
| OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer + additive/metal/polymer + additive. This generic type of deviceincludes prosthesis that have a femoral component made of alloys, suchas cobalt-chromium-molybdenum, and a tibial component(s) and/or aretropatellar resurfacing component made of ultra-high molecular weightpolyethylene plus an additive, such as α-tocopherol. |
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510(K) SUMMARY (PAGE 2 OF 4)
Indications for Use:
iTotal CR KRS
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.
iTotal PS KRS
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee ioint 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.
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510(K) SUMMARY (PAGE 3 OF 4)
| Identification of the Legally Marketed Device(s) (Predicate Device(s)): | ConforMIS iTotal CR Knee Replacement SystemDevice Class: IIProduct Code: JWH, OOG, OIYRegulation Number: 21 CFR 888.3560510(k) Number: K142161, K142404 and K152704ConforMIS iTotal PS Knee Replacement SystemDevice Class: IIProduct Code: JWH, OOG, OIYRegulation Number: 21 CFR 888.3560510(k) Number: K142161, K142404 and K152704 |
|---|---|
| Device Description: | The iTotal® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.Using patient imaging 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 either single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, 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 KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile or non-sterile to be sterilized by the end-user and are for single-use only.The purpose of this submission is to propose dimensional modifications to the iTotal KRS implants and changes to the ancillary instrumentation.The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K142161, K142404 and K152704. |
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510(K) SUMMARY (PAGE 4 OF 4)
| Comparison Summary ofTechnologicalCharacteristics andModifications Proposed: | The modified iTotal KRS and predicate iTotal KRS have the sametechnological characteristics. The modified iTotal KRS consists ofdimensional modifications to the iTotal KRS implants and changes to theancillary instrumentation, but there have been no changes to theintended use or function. The materials, methods of manufacture, andpackaging remain similar to those cleared via K142161, K142404 andK152704. The following non-clinical laboratory tests were performed todetermine substantial equivalence:• Tibial Insert Spine-Femoral Cam Fatigue Testing• Range of Motion Analysis• Cadaveric Evaluation |
|---|---|
| Substantial Equivalence: | Nonclinical Testing: The determination of substantial equivalence forthis device was based on a detailed device description and non-clinicallaboratory testing. The following non-clinical laboratory tests wereperformed to determine substantial equivalence:• Tibial Insert Spine-Femoral Cam Fatigue Testing• Range of Motion Analysis• Cadaveric EvaluationTest results demonstrated that the device is substantially equivalent tothe predicate devices for their intended use. |
| Conclusion: | The determination of substantial equivalence for these devices wasbased on detailed device descriptions. Non-clinical laboratory testingwas performed demonstrating that the devices can be consideredsubstantially equivalent to the predicate devices for the intended uses.Clinical data is not necessary to demonstrate substantial equivalence.Based on the testing conducted, it is concluded that the iTotal CruciateRetaining and Posterior Stabilized Knee Replacement Systems aresubstantially equivalent to the predicate devices: the iTotal CruciateRetaining and Posterior Stabilized Knee Replacement Systems(K142161, cleared November 14, 2014, K142404, cleared December11, 2014 and K152704, cleared October 21, 2015). |
§ 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.