(266 days)
Not Found
No
The summary describes a knee replacement system and patient-specific surgical instruments based on CT scans, but there is no mention of AI or ML being used in the design, manufacturing, or surgical planning process. The "patient-specific ancillary surgical instruments" are described as "pre-navigated to fit the contours of the patient's femoral and tibial anatomies," which is a form of patient-specific design based on imaging, not necessarily AI/ML.
Yes
The device is a total knee replacement system intended for patients with painful joint disease and post-traumatic loss of joint function, which directly addresses a medical condition to restore function and alleviate symptoms.
No.
The device is a total knee replacement system intended to treat painful joint disease and post-traumatic loss of joint function by replacing damaged knee components. It is a therapeutic device, not a diagnostic one. While patient imaging (CT scans) are used to select the appropriate implants, the device itself does not diagnose a condition.
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." It details the materials and components of the physical implants (femoral, tibial, patellar components) and surgical instruments. While it uses patient imaging (CT scans) for implant selection and instrument design, the core device is a physical implant system, not software.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is a surgical implant designed to replace a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint, not by analyzing biological specimens.
- Device Description: The description details the materials and components of the implant and associated surgical instruments. It does not mention any components or processes related to analyzing biological samples.
The device uses patient imaging (CT scans) to select the appropriate implant, but this is for surgical planning and sizing, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Identity Imprint Porous 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.
The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH, OIY, OOG
Device Description
The subject device, Identity Imprint Porous Total Knee Replacement System (including Identity Imprint Porous Cruciate Retaining Total Knee Replacement System) is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with other Conformis Knee Replacement Systems (KRS), the Identity Imprint Porous Knee Replacement System (KRS) 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. The device is intended for cementless fixation however the surgeon may also use cement.
Using patient imaging (CT scans), an Identity Imprint set of implants is selected. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CP Ti) scaffold on the interior surface. The tibial tray is manufactured from alloy (Ti6Al4V-ELI), with a CP Ti porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6Al4V-EL) and CPTi porous metal backing. The layer of CPTi scaffolding bonded to the femoral, tibial, and patellar implants provides a surface for porous ingrowth, promoting biological fixation and obviating the need for bone cement to achieve fixation. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary.
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. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. 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 scans
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sterile field by trained orthopedic surgeons (Use Environment).
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:
- Femoral and Tibial Fatigue testing
- Patella Shear Testing
- Patella Tensile Testing
- Porous Bond Shear and Tensile Strength
- Tibial Micromotion
- Patella Durability/Wear Thru Testing
- MRI Compatibility Testing
- Cadaveric Testing
The subject device verification and validation data provided in this submission supports that the subject device is as safe, effective, and performs as well as or better than the predicate device. No different issues of safety or effectiveness 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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
July 21, 2023
Conformis Inc. Marv Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821
Re: K223316
Trade/Device Name: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY, OOG Dated: October 19, 2022 Received: October 28, 2022
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
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) K223316
Device Name
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
Indications for Use (Describe)
The Identity Imprint Porous 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.
The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
| 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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Image /page/3/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, and the last five letters are in orange.
Traditional 510(k) Summary
| 510(k) Number | K223316 |
|---|---|
| Submitter's Name and Address: | Conformis, Inc. |
| 600 Technology Park Drive, Fourth Floor Billerica, | |
| Massachusetts 01821 | |
| USA | |
| Main Telephone Number Main | |
| Fax Number Establishment | |
| Registration Numbers(s): | 781-345-9164 |
| 781-345-0147 | |
| 3009844603 and 3004153240 | |
| Date of Summary Preparation | October 19, 2022; updated November 30, 2022 |
| Contact Name: | |
| Title: | |
| Contact Telephone: | |
| Contact email: | Mary Kruitwagen |
| Sr. Regulatory Affairs Specialist | |
| 781-345-9038 | |
| Mary.Kruitwagen@conformis.com | |
| Alternate Contact: | |
| Title: | |
| Alternate Contact Telephone: | |
| Alternate Contact email: | Liz Haines |
| Vice President of Regulatory Affairs | |
| (978) 569-6862 | |
| Elizabeth.Haines@conformis.com | |
| Subject Device: (Proprietary/ | |
| Trade Name) | Identity Imprint Porous Total Knee Replacement System, |
| Identity Imprint Porous Cruciate Retaining Total Knee | |
| Replacement System | |
| Common Usual Name | Knee Replacement System |
| Type of Submission | Traditional 510(k) |
| Device Class | II |
| Regulation Number(s): | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/ |
| polymer porous-coated uncemented prosthesis | |
| 21 CFR 888.3560 - Knee joint patellofemorotibial polymer/ | |
| metal/polymer semiconstrained cemented prosthesis | |
| Product Code(s) | MBH: prosthesis, knee, patello/femorotibial, semi- |
| constrained, uncemented, porous, coated, polymer/metal/ | |
| polymer | |
| JWH: prosthesis, knee, patellofemorotibial, semi-constrained, | |
| cemented, polymer/metal/polymer | |
| OIY: prosthesis, knee, patellofemorotibial, semi-constrained, | |
| cemented, polymer + additive/metal/polymer + additive | |
| OOG: knee arthroplasty implantation system | |
| Classification Panel | Orthopedics |
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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, except for the "ORM" which is in orange. The logo is simple and modern, and the colors are eye-catching.
| Manufacturing Site | Conformis Inc.
600 Research Drive
Wilmington, Ma. 01887
USA |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration | 3004153240 |
| Sterilization Site | Isomedix Operations Inc.
Steris Isomedix Services
3459 South Clinton Ave.
S. Plainfield, NJ 07080
USA |
| Establishment Registration | 2246552 |
| Primary Predicate Device: | Arthrex iBalance® TKA System |
| Primary Predicate Device 510(k): | K141635, September 3, 2014 |
| Primary Predicate Device Product
Code(s): | MBH: prosthesis, knee, patello/femorotibial, semi-
constrained, uncemented, porous, coated, polymer/metal/
polymer
JWH: prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer/metal/polymer |
| Secondary Predicate Device: | Identity Imprint Knee Replacement System
Identity Imprint CR Knee Replacement System |
| Secondary Predicate Device 510(k): | K221404 |
| Secondary Predicate Device Product
Codes: | JWH: prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer/metal/polymer
OIY: prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer + additive/metal/polymer + additive
OOG: knee arthroplasty implantation system |
Device Description:
The subject device, Identity Imprint Porous Total Knee Replacement System (including Identity Imprint Porous Cruciate Retaining Total Knee Replacement System) is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with other Conformis Knee Replacement Systems (KRS), the Identity Imprint Porous Knee Replacement System (KRS) 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. The device is intended for cementless fixation however the surgeon may also use cement.
Using patient imaging (CT scans), an Identity Imprint set of implants is selected. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure
5
Image /page/5/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, with the top portion in orange and the bottom portion in black.
titanium (CP Ti) scaffold on the interior surface. The tibial tray is manufactured from alloy (Ti6Al4V-ELI), with a CP Ti porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6Al4V-EL) and CPTi porous metal backing. The layer of CPTi scaffolding bonded to the femoral, tibial, and patellar implants provides a surface for porous ingrowth, promoting biological fixation and obviating the need for bone cement to achieve fixation. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary.
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. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately.
The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment).
The Imprint Porous Knee Replacement System is compatible with cemented Identity Imprint CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique.
The Indications for Use:
The Identity Imprint Porous 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, 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
The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
Technological Characteristics:
The subject device single-use, disposable patient-specific instrumentation, implants, and reusable instruments are similar to the predicate device in operating principle, fundamental technology, design, and materials. The subject device implants use the same materials as the predicate Identity Imprint CR
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Image /page/6/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 "ORM" in Conformis is in orange.
KRS device, with a porous coating on the bone cut sides of the femoral and tibial implants. The patellar component also has a porous coating on metal backing. The same as used in the predicate Arthrex iBalance® TKA device. The fixation method of the subject device is for cementless application, although the surgeon may use cement if desired. 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 or similar to the predicate Identity Imprint CR KRS.
The focus of this submission is to seek clearance for a porous version of the Identity Imprint Porous Total Knee Replacement System along with hybrid combinations of the cemented implants in K221404.
Non-Clinical Performance Evaluation:
There is no change to the articulating surfaces, UHMWPe inserts or interlocks compared to the predicate Identity Imprint CR KRS device. The testing performed and included in this submission is relative to the areas of change from the - predicate Identity Imprint CR KRS device. The following confirmatory testing was performed:
- . Femoral and Tibial Fatigue testing
- Patella Shear Testing
- Patella Tensile Testing
- Porous Bond Shear and Tensile Strength
- Tibial Micromotion
- Patella Durability/Wear Thru Testing
- MRI Compatibility Testing
- Cadaveric Testing
The subject device verification and validation data provided in this submission supports that the subject device is as safe, effective, and performs as well as or better than the predicate device. No different issues of safety or effectiveness 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 Porous Total Knee Replacement System is substantially equivalent to the predicate devices.