(30 days)
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 device itself or in the process of selecting the standard implant. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is a total knee replacement system intended to treat knee joint pain and disability due to various debilitating conditions.
No
Explanation: The device is a total knee replacement system. Its intended use is to replace knee joints in patients with pain and disability, not to diagnose the cause of such conditions. While it utilizes patient imaging for selecting implant size, this is for surgical planning rather than diagnostic purposes.
No
The device description clearly states it is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation, and lists the materials of the physical implants (CoCrMo alloy, titanium alloy, UHMWPE). This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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 description clearly states that the Identity Imprint CR Total Knee Replacement System is a knee replacement system consisting of implants (femoral, tibial, and patellar components) and surgical instruments. These are physical devices implanted into the body.
- Intended Use: The intended use is to replace a damaged knee joint in patients with pain and disability. This is a surgical intervention, not a diagnostic test performed on a sample.
- Input: While the system uses patient imaging (CT or MR scans) to select the appropriate standard implant size, this imaging is used for surgical planning and device selection, not for diagnosing a condition from a biological sample.
Therefore, the Identity Imprint CR Total Knee Replacement System is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, 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 insert option should be utilized when additional anterior-posterior constraint is desired.
Product codes
JWH, OOG, OIY
Device Description
The subject device, Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, 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 of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This submission also seeks clearance of Cruciate Sacrificing (CS) Insert to be used with the cleared (secondary predicate) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS).
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:
- Virtual Range of Motion (ASTM F2083)
- Verification/Validation Bioskills Lab
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
April 27, 2023
Conformis Inc. Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive Fourth Floor Billerica, Massachusetts 01821
Re: K230844
Trade/Device Name: Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG,OIY Dated: March 24, 2023 Received: March 28, 2023
Dear Mary Kruitwagen:
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.
1
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.
Jesse Muir -S
Jesse Muir, Ph.D. Acting 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
Submission Number (if known)
Device Name
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
Indications for Use (Describe)
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, 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 insert option should be utilized when additional anterior-posterior constraint is desired.
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)
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
Image /page/3/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 below it. The first three letters of the word are in black, while the last four letters are in orange.
1
K230844 pg. 1 of 3 510(k) Summary
| Submitter's Name and Address: | Conformis, Inc.
600 Technology Park Drive,
Fourth Floor
Billerica, MA 01821
USA |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number(s): | 3009844603 and 3004153240 |
| Date Summary was Prepared: | March 24, 2023 |
| Contact Person: | Mary Kruitwagen
Sr. Regulatory Affairs Specialist |
| Contact Information: | Mary.Kruitwagen@conformis.com
781-345-9038 |
| Trade/Device Name(s) | IdentityTM ImprintTM Cruciate Retaining (CR) Knee Replacement System
(KRS) with Cruciate Sacrificing (CS) Insert |
| Common Name: | Knee Replacement System |
| Device Class: | Class 2 |
| Regulation Number(s) | 21 CFR 888.3560 |
| Classification Names and Product
Codes: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer (JWH)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer + Additive/Metal/Polymer + Additive (OIY)
Knee Arthroplasty Implantation System (OOG) |
| Primary Predicate Device: | K210809 iTotal® IdentityTM Cruciate Retaining (CR) Knee Replacement
System (with CS insert) |
| Primary Predicate Regulation
Number(s) | 21 CFR 888.3560 |
| Primary Predicate Classification
Names and Product Codes: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer (JWH)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer + Additive/Metal/Polymer + Additive (OIY)
Knee Arthroplasty Implantation System (OOG) |
| Secondary Predicate Device:
Reference Predicate Regulation
Number(s) | K221404 Identity Imprint Cruciate Retaining Knee Replacement System
21 CFR 888.3560 |
| Reference Predicate Classification
Names and Product Codes: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer (JWH)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer + Additive/Metal/Polymer + Additive (OIY)
Knee Arthroplasty Implantation System (OOG) |
4
K230844 pg. 2 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 below it. The first three letters of the word are in black, while the last four letters are in orange. The logo is simple and modern, and the colors are eye-catching.
Device Description:
The subject device, Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, 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 of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This submission also seeks clearance of Cruciate Sacrificing (CS) Insert to be used with the cleared (secondary predicate) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS).
Indications for Use:
The Identity Imprint Cruciate Retaining 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 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 insert option should be utilized when additional anterior-posterior constraint is desired.
Technological Characteristics:
The focus of this submission is on clearance of Cruciate Sacrificing tibial insert of iPoly™ XE offered in thicknesses of 6mm to 18mm to compatible with Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) which is a standardized knee replacement system.
The subject Cruciate Sacrificing (CS) Insert has identical articular surfaces, design rules and features as the Conformis Identity Imprint CS Insert Special 510(k) Confidential Page 2 of 3
5
Image /page/5/Picture/0 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black above the company name. The company name "CONFORMIS" is written in a sans-serif font, with the "FORMIS" portion of the name in orange.
K230844 pg. 3 of 3
primary predicate iTotal™ Identity™ Cruciate Sacrificing (CS) Insert. The different between the two inserts is that the subject insert is being standardized for use with the Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS).
The Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, subject device single-use, disposable patient-specific instrumentation, implants, and reusable instruments remain identical to the secondary 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 and automated manufacturing methods remain the same as the predicate.
Non-Clinical Performance Evaluation:
The following testing was performed:
- Virtual Range of Motion (ASTM F2083)
- Verification/Validation Bioskills Lab ●
Conclusion:
Based on a comparison of the intended use and technological characteristics of the subject devices to predicate devices, and the results of the confirmatory testing, it is concluded that the proposed Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is considered substantially equivalent.