(111 days)
Not Found
No
The document describes a knee replacement system and mentions using CT scans for patient-specific implant design or standard size selection. It does not mention any AI or ML technology being used in the design, selection, or surgical guidance process.
Yes
Explanation: The device is a knee replacement system intended to treat painful joint disease and disability, which is a therapeutic purpose.
No
This device is described as a "Knee Replacement System" and its components are implants (femoral, tibial, and patellar components) used in total knee replacement surgery. It is a prosthetic device for treatment, not a device for diagnosing conditions.
No
The device description clearly states that the device consists of physical components (femoral, tibial, and patellar components made of CoCrMo, titanium alloy, and UHMWPE) and surgical instruments, in addition to utilizing software for design and selection.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The iTotal Identity and Identity Imprint Knee Replacement Systems are implants designed to replace damaged knee joints. They are physical devices surgically inserted 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 samples.
- Input: While the system uses CT scans for planning, the primary function is the physical implant, not the analysis of biological specimens.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee jount 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 or osteonecrosis of the knee.
Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS)
The iTotal Identity Posterior Stabilized 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
Pamful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, osteonerosis 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.
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS)
The Identity™ Imprint™ CR Total 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 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.
Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS)
The Identity™ Imprint™ PS Total 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, polyarthritis, 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, OIY, OOG
Device Description
The iTotal Identity and Identity Imprint Knee Replacement Systems (KRS) are semi-constrained total knee prosthetic devices consisting of femoral, tibial, and patellar components. These devices are intended for treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Patient imaging (CT scans) can be used to design patient-specific implants (iTotal Identity) or to select standard sized implants (Identity Imprint), to meet the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.
For user convenience, single-use, patient-specific surgical instruments are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
knee
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)
The results of verification and validation testing confirmed that the software performed as well as or better than the predicates. No different questions of safety or effectiveness were raised. Thus the subject devices are considered substantially equivalent to the predicate devices.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
July 17, 2023
Conformis, Inc. Nancv Giezen Manager Regulatory Affairs 600 Technology Park Dr. Billerica, Massachusetts 01830
Re: K230846
Trade/Device Name: iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS); iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS); Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS); Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG Dated: March 27, 2023 Received: June 15, 2023
Dear Nancy Giezen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230846
Device Name
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS), iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS), Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS), Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS)
Indications for Use (Describe)
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee jount 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 or osteonecrosis of the knee. Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS)
The iTotal Identity Posterior Stabilized 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
Pamful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, osteonerosis 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.
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS)
The Identity™ Imprint™ CR Total 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 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.
3
Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS)
The Identity™ Imprint™ PS Total 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, polyarthritis, 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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K230846 Page 1 of 3
Image /page/4/Picture/1 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written in black and orange letters below it. The letters "CON" are in black, while the letters "FORMIS" are in orange.
510(k) Summary
Prepared on: 2023-07-17
Contact Details
| Applicant Name: | Conformis, Inc. |
|---|---|
| Applicant Address: | 600 Technology Park Dr. Billerica MA 01830 United States |
| Applicant Contact Telephone: | (781) 345-9058 |
| Applicant Contact: | Nancy Giezen |
| Applicant Contact Email: | Nancy.Giezen@conformis.com |
Device Name
Device Trade Name:
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS)
Common Name:
Knee replacement system
Classification Name:
Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
Regulation Number: 888.3560
Product Code:
JWH, OIY, OOG
Legally Marketed Predicate Devices
Predicate #: Predicate Trade Name: Product Codes: iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) JWH. OIY. OOG K210809 iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS) JWH, OIY, OOG K210252 K221404 Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) JWH, OIY, OOG Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS) JWH. OIY, OOG
Device Description Summary
The iTotal Identity and Identity Imprint Knee Replacement Systems (KRS) are semi-constrained total knee prosthetic devices consisting of femoral, tibial, and patellar components. These devices are intended for treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Patient imaging (CT scans) can be used to design patient-specific implants (iTotal Identity) or to select standard sized implants (Identity Imprint), to meet the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.
For user convenience, single-use, patient-specific surgical instruments are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
5
Image /page/5/Picture/1 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written in black and orange letters below it. The first four letters of the word are in black, and the last four letters are in orange.
Intended Use/Indications For Use
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (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, 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 structures can be returned to adequate function and stability.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (KRS)
The iTotal Identity Posterior Stabilized 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,
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.
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS)
The Identity™ Imprint™ CR Total 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, rheumatoid arthritis or osteonecrosis of the
6
Image /page/6/Picture/1 description: The image shows the ConforMIS logo. The logo features the word "CONFORMIS" in a sans-serif font, with the "FORMIS" portion of the word in orange. Above the word is a stylized "C" shape in orange with a black outline.
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.
Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS)
The Identity™ Imprint™ PS Total 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, 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.
Indications For Use Comparison
The indications for use are the same as compared with the predicate devices.
Technological Comparison
The subject devices which include the implants, single-use patient-specific instruments and reusable instruments remain identical to the predicate devices in operating principle, fundamental technology, design and materials. The purpose of this submission is to incorporate software updates to improve manufacturing efficiencies.
Non-Clinical and/or Clinical Test Summary and Conclusions
The results of verification and validation testing confirmed that the software performed as well as or better than the predicates. No different questions of safety or effectiveness were raised. Thus the subject devices are considered substantially equivalent to the predicate devices.