(61 days)
Not Found
Unknown
The description mentions "a combination of proprietary and off the shelf software" used for patient-specific implant design based on imaging, which could potentially incorporate AI/ML, but the summary does not explicitly state this.
Yes
The device is a knee replacement system intended to treat painful joint disease and post-traumatic loss of joint function, which are therapeutic interventions.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing conditions.
No
The device description explicitly states that the iTotal KRS are "patient specific tricompartmental faceted knee replacement systems" consisting of "femoral, tibial, and patellar components" manufactured from materials like CoCrMo alloy and polyethylene. It also mentions "accessory orthopedic manual surgical instruments." While software is used in the design process, the final device is a physical implant and associated instruments, not software alone.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The iTotal KRS is described as a "patient specific tricompartmental faceted knee replacement system." It is a physical implant (femoral, tibial, and patellar components) intended to replace a damaged knee joint.
- Intended Use: The intended use is to treat knee joint pain and disability by surgically implanting a prosthetic device.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing. The "patient imaging" mentioned is used for designing the patient-specific implant, not for in vitro diagnostic purposes.
Therefore, the iTotal KRS is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging scans
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The following non-clinical laboratory tests were performed to determine substantial equivalence:
• Tibial Insert Spine-Femoral Cam Fatigue Testing
• Range of Motion Analysis
• Cadaveric Evaluation
Test results demonstrated that the device is substantially equivalent to the predicate devices for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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."
3
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."
4
8.0 510(K) SUMMARY (PAGE 1 OF 4)
| Submitter's Name and
Address: | ConforMIS, Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 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 (iTotal
CR KRS)
ConforMIS iTotal® Posterior Stabilized Knee Replacement System
(iTotal PS KRS) |
| Common Name(s): | Total Knee Replacement System |
| Regulatory Status and
Regulation Number: | Class II
21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented 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 knee
arthroplasty 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 device
includes prosthesis that have a femoral component made of alloys, such
as cobalt-chromium-molybdenum, and a tibial component(s) and/or a
retropatellar resurfacing component made of ultra-high molecular weight
polyethylene plus an additive, such as α-tocopherol. |
5
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.
6
510(K) SUMMARY (PAGE 3 OF 4)
| Identification of the Legally Marketed Device(s) (Predicate Device(s)): | ConforMIS iTotal CR Knee Replacement System
Device Class: II
Product Code: JWH, OOG, OIY
Regulation Number: 21 CFR 888.3560
510(k) Number: K142161, K142404 and K152704
ConforMIS iTotal PS Knee Replacement System
Device Class: II
Product Code: JWH, OOG, OIY
Regulation Number: 21 CFR 888.3560
510(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. |
7
510(K) SUMMARY (PAGE 4 OF 4)
| Comparison Summary of
Technological
Characteristics and
Modifications Proposed: | The modified iTotal KRS and predicate iTotal KRS have the same
technological characteristics. The modified iTotal KRS consists of
dimensional modifications to the iTotal KRS implants and changes to the
ancillary instrumentation, but there have been no changes to the
intended use or function. The materials, methods of manufacture, and
packaging remain similar to those cleared via K142161, K142404 and
K152704. The following non-clinical laboratory tests were performed to
determine substantial equivalence:
• Tibial Insert Spine-Femoral Cam Fatigue Testing
• Range of Motion Analysis
• Cadaveric Evaluation |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | Nonclinical Testing: The determination of substantial equivalence for
this device was based on a detailed device description and non-clinical
laboratory testing. The following non-clinical laboratory tests were
performed to determine substantial equivalence:
• Tibial Insert Spine-Femoral Cam Fatigue Testing
• Range of Motion Analysis
• Cadaveric Evaluation
Test results demonstrated that the device is substantially equivalent to
the predicate devices for their intended use. |
| Conclusion: | The determination of substantial equivalence for these devices was
based on detailed device descriptions. Non-clinical laboratory testing
was performed demonstrating that the devices can be considered
substantially 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 Cruciate
Retaining and Posterior Stabilized Knee Replacement Systems are
substantially equivalent to the predicate devices: the iTotal Cruciate
Retaining and Posterior Stabilized Knee Replacement Systems
(K142161, cleared November 14, 2014, K142404, cleared December
11, 2014 and K152704, cleared October 21, 2015). |