(101 days)
Not Found
No
The description focuses on standard implant selection based on imaging and patient-specific surgical instruments, with no mention of AI or ML for analysis, planning, or other functions.
Yes
The device is a knee replacement system intended to alleviate pain and disability caused by diseased or damaged knee joints, which aligns with the definition of a therapeutic device.
No
This device is a knee replacement system intended for surgical implantation, not for diagnosing medical conditions. It treats conditions rather than identifying them.
No
The device description explicitly states it includes physical components such as femoral, tibial, and patellar implants made of CoCrMo, titanium alloy, and UHMWPE, as well as surgical instruments. This indicates it is a hardware-based medical device, not software-only.
No, 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 about a person's health. They are used outside of the body.
- Device Description: The Identity Imprint Knee Replacement System is a surgical implant intended to be placed inside the body to replace a damaged knee joint.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint, not by analyzing biological samples.
While the device uses patient imaging (CT or MR scans) to select the appropriate implant, this imaging is used for surgical planning and component selection, not for diagnostic testing of biological samples.
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 new device offering of 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
CT or MR 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)
Non-Clinical Performance Evaluation:
The following confirmatory testing was performed:
- Cadaver/bioskills lab
- Femoral implant fatigue test ●
- implant range of motion evaluation ●
The assessment of the non-clinical data provided in this submission supports that the subject device is safe, effective, and performs as well as or better than the predicate device(s). 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.
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
May 6, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Conformis Inc. Kara Johnson Director, Regulatory Affairs 600 Technology Park Drive Billerica, Massachusetts 01821
Re: K210191
Trade/Device Name: Identity Imprint Knee Replacement System 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: April 16, 2021 Received: April 19, 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 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
1
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 mediation-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) K210191
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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K210191 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: | January 21, 2021 |
| Contact Person: | Kara Johnson |
| Director, Regulatory Affairs | |
| Telephone: 781-832-5402 | |
| Email: kara.johnson@conformis.com |
Trade/Device Name(s): Identity Imprint Knee Replacement System
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 Device
(Primary Predicate): iTotal Identity Cruciate Retaining (CR) Knee Replacement System (K190562)
(Secondary Predicates):
iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023) iTotal CR & PS KRS - addition of iPoly XE NMA GUR 1020E (K203447)
Device Description:
The subject device, Identity Imprint Knee Replacement System, is a new device offering of a
4
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K210191 Page 2 of 3
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.
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:
5
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K210191 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 devices incorporate updates to the material and design which are consistent with previously cleared devices. The operating principle, fundamental technology, manufacturing methods and sterilization options are the same as the predicates.
The single-use, disposable patient-specific instrumentation design processes for the subject device are similar to those employed for the predicate devices. The implants and instrumentation serve the same function and employ the same technological characteristics as those of the predicate devices. The subject device components are composed of the same materials, respectively, as the predicate devices. The subject device uses the same packaging materials and sterilization methods as those of the predicate devices.
Non-Clinical Performance Evaluation:
The following confirmatory testing was performed:
- Cadaver/bioskills lab
- Femoral implant fatigue test ●
- implant range of motion evaluation ●
The assessment of the non-clinical data provided in this submission supports that the subject device is safe, effective, and performs as well as or better than the predicate device(s). 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.