(57 days)
Not Found
No
The summary describes a patient-specific knee implant designed using patient imaging, but there is no mention of AI or ML being used in the design process or any other aspect of the device or its associated instruments. The focus is on patient-specific geometry and standard mechanical testing.
Yes
The device is a knee replacement system intended to treat conditions like painful joint disease and post-traumatic loss of joint function, thereby alleviating pain and improving joint function.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing medical conditions. It treats pain and disability, rather than identifying or characterizing a disease.
No
The device description clearly states it includes physical components like femoral, tibial, and patellar components made of CoCrMo alloy, titanium alloy, and UHMWPE, as well as surgical instruments. This indicates it is a hardware device, not software-only.
Based on the provided information, 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 iTotal Identity Posterior Stabilized Knee Replacement System is a surgical implant designed to replace a damaged knee joint. It is a physical device implanted 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: The input is patient imaging (CT or MR scans), which is used for designing the physical implant, not for diagnostic testing of biological samples.
Therefore, this device falls under the category of a medical device (specifically, a surgical implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, 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 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
JWH, OIY, OOG
Device Description
Conformis knee replacement systems are patient-specific 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 patient-specific implant is designed 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, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity Posterior Stabilized Knee Replacement System 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)
The following confirmatory testing was performed:
- Insert interlock/Modularity per ASTM F1814 and ASTM F2083
- Tibial Tray Fatigue per ASTM F1800 and ASTM F2083
- Simulated Use Testing
- MR Compatibility per ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07
Based on a comparison of the intended use and technological characteristics to predicate devices and on the results of confirmatory testing it is concluded that the proposed iTotal Identity Posterior Stabilized Knee Replacement System is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K161668, K193105, K190562, K193105, K952830, K060515
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
June 16, 2020
Image /page/0/Picture/1 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Conformis, Inc. Nancy Giezen Manager Regulatory Affairs 600 Technology Park Drive Billerica, Massachusetts 01821
Re: K201023
Trade/Device Name: iTotal Identity Posterior Stabilized 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 15, 2020 Received: April 20, 2020
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 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 (OS) 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.
Ting Song, Ph.D., R.A.C. 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
510(k) Number (if known) K201023
Device Name
iTotal Identity Posterior Stabilized Knee Replacement System
Indications for Use (Describe)
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:
· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, 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 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
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: | June 10th, 2020 |
| Contact Person: | Nancy Giezen
Manager Regulatory Affairs
Telephone: 781-345-9058 |
Trade/Device Name(s): iTotal Identity Posterior Stabilized 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 Posterior Stabilized (PS) Knee Replacement System (K161668, K193105)
(Secondary Predicates):
iTotal Identity Cruciate Retaining (CR) Knee Replacement System (K190562) iTotal Cruciate Retaining (CR) Knee Replacement System (K193105) DePuy PFC Sigma Knee Prosthesis (K952830, K060515)
4
Device Description:
Conformis knee replacement systems are patient-specific 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 patient-specific implant is designed 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, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity Posterior Stabilized Knee Replacement System 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:
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, 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 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.
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.
5
Non-Clinical Performance Evaluation:
The following confirmatory testing was performed:
- Insert interlock/Modularity per ASTM F1814 and ASTM F2083 ●
- Tibial Tray Fatigue per ASTM F1800 and ASTM F2083 ●
- Simulated Use Testing ●
- MR Compatibility per ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07
Conclusion:
Based on a comparison of the intended use and technological characteristics to predicate devices and on the results of confirmatory testing it is concluded that the proposed iTotal Identity Posterior Stabilized Knee Replacement System is substantially equivalent.