(51 days)
Not Found
No
The summary describes a standard knee replacement system with patient-specific instrumentation based on imaging, but there is no mention of AI or ML being used in the design, planning, or operation of the device. The software verification and validation mentioned likely pertains to standard medical device software, not AI/ML algorithms.
No.
The device is a knee replacement system used to treat knee joint pain and disability, which is a prosthetic device rather than a therapeutic device in the sense of providing therapy or treatment beyond replacement.
No
The device is a knee replacement system used for treatment of knee joint pain and disability, not for diagnosis.
No
The device description clearly states it includes physical components such as femoral, tibial, and patellar implants made of CoCrMo alloy, titanium alloy, and UHMWPE, as well as surgical instruments. While software is mentioned for verification and validation, the core device is a physical knee replacement system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Identity Imprint Knee Replacement System is a surgical implant intended to replace a damaged knee joint. It is a physical device implanted into the body to restore function and alleviate pain.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient's body. While it uses patient imaging (CT or MR scans) to select the appropriate implant size and guide surgery, this is for surgical planning and execution, not for analyzing biological samples.
Therefore, the Identity Imprint Knee Replacement System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Identity Imprint 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 use of a prosthetic device that treats only one or two of the three knee compartments, such as 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 of 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 subject device, Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans), a standard implant is selected that best meets 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, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging (either CT or MR scans)
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 Performance Evaluation:
The following confirmatory testing was performed:
- . Software Verification and Validation
The software verification and validation data provided in this submission supports that the subject device is safe, effective, and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised.
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.
Identity Imprint Knee Replacement System (K210191), iTotal Identity Cruciate Retaining (CR) Knee Replacement System (K190562), iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023)
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
September 23, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Conformis Inc. Kara Johnson Sr. Director, Regulatory Affairs 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821
Re: K212411
Trade/Device Name: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) 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: August 2, 2021 Received: August 3, 2021
Dear Kara Johnson:
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 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
1
542 of the Act); 21 CFR 1000-1050.
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-
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,
Ting Song, Ph.D., R.A.C. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212411
Device Name
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Indications for Use (Describe)
The Identity Imprint 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 use of a prosthetic device that treats only one or two of the three knee compartments, such as 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 of 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K212411 page 1 of 3 510(k) SUMMARY
| Submitter's Name and Address: | Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821 |
|---|---|
| Establishment Registration Number(s): | 3009844603 and 3004153240 |
| Date Summary was Prepared: | July 30, 2021 |
| Contact Person: | Kara Johnson |
| Sr. Director, Regulatory Affairs | |
| Telephone: 781-832-5402 | |
| Email: kara.johnson@conformis.com |
Trade/Device Name(s):
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Common Name:
Knee Replacement System
Device Class: Class II
Regulation Numbers:
888.3560
Classification Names and Product Codes:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerKnee Arthroplasty Implantation System; JWH, OIY, OOG
Legally Marketed Predicate Devices
(Primary Predicate): Identity Imprint Knee Replacement System (K210191) (Secondary Predicates): iTotal Identity Cruciate Retaining (CR) Knee Replacement System (K190562) iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023)
Device Description:
The subject device, Identity Imprint Knee Replacement System, is a knee replacement system
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Image /page/4/Picture/0 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 to the right of the "C". The "ORMIS" portion of the word is in orange.
K212411 page 2 of 3
including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans), a standard implant is selected that best meets 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, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants 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.
Indications for Use: Identity Imprint CR KRS
The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as 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.
Identity Imprint PS KRS
The Identity Imprint 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 unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
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K212411 page 3 of 3
- 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 bicompartental implants
- Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
Technological Characteristics:
The subject device single-use, disposable patient-specific instrumentation, implants, and reusable instruments remain identical to the predicate device in operating principle, fundamental technology, design, and materials. The subject device uses the same packaging materials and sterilization methods as those of the predicate device. The manual manufacturing methods remain the same as the predicate. The focus of this submission is on manufacturing software enhancements aimed at adding an option to use an automated process in lieu of the previously cleared manual processes in order to improve manufacturing efficiencies.
Non-Clinical Performance Evaluation:
The following confirmatory testing was performed:
- . Software Verification and Validation
The software verification and validation data provided in this submission supports that the subject device is safe, effective, and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised.
Conclusion:
Based on a comparison of the intended use and technological characteristics to the predicate devices and on the results of confirmatory testing it is concluded that the proposed Identity Imprint KRS is substantially equivalent.