(29 days)
Not Found
No
The summary describes software used for patient-specific implant design based on CT scans, but it does not mention or imply the use of AI or ML algorithms for this process. The focus is on proprietary and off-the-shelf software for geometric and anatomical requirements.
Yes
The device is a knee replacement system intended to treat painful joint disease and restore joint function, which are therapeutic purposes.
No
Explanation: This device is a knee replacement system used for treatment by replacing the knee joint, not for diagnosing a condition. While it uses imaging for design, its primary function is therapeutic.
No
The device description clearly states that the iTotal PS KRS is a physical implant system consisting of femoral, tibial, and patellar components made of CoCrMo alloy and UHMWPE. While software is used in the design process, the device itself is a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The iTotal® PS Knee Replacement System is a physical implant (femoral, tibial, and patellar components) designed to replace a damaged knee joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint, not by analyzing biological specimens.
- Image Processing: While the device uses imaging (CT scans) to design a patient-specific implant, this is for surgical planning and device manufacturing, not for analyzing biological samples for diagnostic purposes.
Therefore, the iTotal® PS Knee Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iTotal® PS 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, traumatoid arthritis, polyarthritis, 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY
Device Description
The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
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 K160025 & K153217.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use. The following non-clinical laboratory testing was performed:
Detailed software description and software verification and validation testing of proprietary software iTotal FemJigs PS v1.0. Detailed software description and software verification and validation testing of proprietary software iTotal TibJigs PS v1.0.
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with the heads of the figures forming the top part of the symbol.
July 15, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conformis, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K161668 Trade/Device Name: ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System (iTotal PS) 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: June 13, 2016 Received: June 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Ms. Amita Shah
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161668
Device Name
ConforMIS iTotal® PS Knee Replacement System (iTotal PS)
Indications for Use (Describe)
The iTotal® PS 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, traumatoid arthritis, polyarthritis, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
8.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name and
Address: | ConforMIS, Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | June 13, 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® PS Knee Replacement System (iTotal PS) |
| 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 prostheses 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. |
4
510(K) SUMMARY (PAGE 2 OF 5)
Indications for Use: The iTotal® Posterior Stabilized (PS) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, . rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- . Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
ldentification of the Legally Marketed Device(s) (Predicate Device(s)):
ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS) Device Class: . Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K160025 & K153217
5
510(K) SUMMARY (PAGE 3 OF 5)
Device Description: The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
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 K160025 & K153217.
6
510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The proposed iTotal PS KRS and predicate iTotal PS KRS have the same technological characteristics. There have been no changes to the proposed iTotal PS KRS device with respect to design, materials and methods of manufacture, packaging, or sterilization. The designs of the device remains similar to that cleared in K160025 and K153217.
Modifications which represent improving manufacturing efficiencies are primarily focused on adding the option of automating the generation of the iTotal PS iJigs using the proprietary software modules iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0.
| Characteristic | Predicate
iTotal PS KRS
(K160025 and
K153217) | Proposed
iTotal PS KRS
(This submission) |
|---------------------------------------------|--------------------------------------------------------|------------------------------------------------|
| Generation of
iTotal PS
Femoral iJigs | iTotal FemJigs v3.0
and Manual process | iTotal FemJigs PS
v1.0 or
Manual process |
| Generation of
iTotal PS Tibial
iJigs | Manual process | iTotal TibJigs PS
v1.0 or
Manual process |
Table 8.0-1: Comparison Between the Proposed and Predicate Device
7
510(K) SUMMARY (PAGE 5 OF 5)
| Substantial Equivalence: | The determination of substantial equivalence for this device was based on a
detailed device description. Non-clinical laboratory testing was performed
demonstrating that the device can be considered substantially equivalent to the
predicate device for the intended use. The following non-clinical laboratory
testing was performed:
Detailed software description and software verification and validation
testing of proprietary software iTotal FemJigs PS v1.0. Detailed software description and software verification and validation
testing of proprietary software iTotal TibJigs PS v1.0. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the testing conducted, it is concluded that the proposed iTotal
Posterior Stabilized Knee Replacement System is substantially equivalent to the
predicate iTotal Posterior Stabilized Knee Replacement System (K160025,
cleared March 07, 2016, and K153217, cleared January 07, 2016). |