(156 days)
Unknown
The summary mentions "proprietary and off the shelf software" used for patient-specific implant design based on imaging, which could potentially incorporate AI/ML, but there is no explicit mention of these technologies. The description focuses on the physical device and its components.
Yes.
The device is a knee replacement system intended to treat painful joint disease and restore joint function in patients, which clearly aligns with the definition of a therapeutic device.
No
The device is a knee replacement system used for treatment, not for diagnosing a condition. Its purpose is to replace part of the knee joint, as indicated by its "Intended Use / Indications for Use" and "Device Description."
No
The device description clearly states that the device is a "patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system" consisting of "femoral, tibial, and patellar components" made of various metal and polyethylene materials. While software is used in the design process, the device itself is a physical implant.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Function: The iTotal Identity Cruciate Retaining (CR) 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 clearly states it's for "use as a total knee replacement in patients with knee joint pain and disability." This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Device Description: The description details the materials and components of the implant itself (femoral, tibial, and patellar components), not reagents or equipment for analyzing biological samples.
- Performance Studies: The performance studies listed focus on the mechanical properties, biocompatibility, and usability of the implant and associated surgical instruments, not on the accuracy or reliability of a diagnostic test.
The use of "patient imaging" and software to design the patient-specific implant is part of the planning and manufacturing process for the implant, not a diagnostic test performed on a biological specimen.
N/A
Intended Use / Indications for Use
The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY
Device Description
The iTotal Identity® Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal Identity CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal Identity CR KRS is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components.
Using patient imaging and a combination of proprietary and off the shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE), and either one or two polyethylene inserts. These inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked Vitamin E infused polyethylene). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the primary predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity CR KRS 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
Using patient imaging and a combination of proprietary and off the shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging
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)
Substantial equivalence is based on intended use and the technological characteristics of the proposed iTotal Identity CR KRS, as well as non-clinical testing conducted to confirm that proposed iTotal Identity CR KRS is substantially equivalent to the predicate devices. Specifically, the following testing was performed:
- Cadaver (instrumentation testing & usability)
- Insert interlock/Modularity
- Tibial tray stem fatigue
- Tibial tray stem assembly/disassembly torque
- Tibial tray and stem extension particle analysis/fretting corrosion
- Biocompatibility
- MRI Compatibility
- Patella test justification
- Tibial Insert justification (contact area, range of motion, constraint testing).
- Sterilization validation
- Reusable instrument cleaning & sterilization (new tray and new instruments)
All testing has demonstrated that the proposed iTotal Identity CR KRS is substantially equivalent to the predicate devices.
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.
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.
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August 8, 2019
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 & 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. Paul Smolenski Sr. RA Manager 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821
Re: K190562
Trade/Device Name: iTotal Identity Cruciate Retaining 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, OOG, OIY Dated: July 9, 2019 Received: July 10, 2019
Dear Paul Smolenski:
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
1
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 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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Conformis iTotal Identity Cruciate Retaining (CR) Knee Replacement System
Indications for Use (Describe)
The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) 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, 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.
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) |
Prescription Ooc (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 four 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.
510K SUMMARY (page 1 of 5)
| 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: | March 4th, 2019 |
| Contact Person: | Paul Smolenski
Sr. Regulatory Affairs Manager
Telephone: 781-374-5586
Fax: 781-345-0147
E-mail: paul.smolenski@conformis.com |
| Trade/Device Name: | Conformis itotal Identity® Cruciate Retaining (CR) Knee
Replacement System (iTotal CR KRS) |
| Common Name: | Total Knee Replacement System |
| Device Class: | Class II |
| Regulation Number
and Description: | 21 CFR 888.3560
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis. |
| Classification Name: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer |
| Product Code:
(Classification) | JWH |
| Product Code(s):
(Subsequent) | OOG: Knee Arthroplasty Implantation System
OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer + Additive/Metal/Polymer + Additive |
| Legally Marketed
Predicate Device
(Primary Predicate): | Conformis iTotal® Cruciate Retaining Knee Replacement System
("iTotal CR KRS"), K180906, cleared May 16, 2018). |
| Legally Marketed
Predicate Device | Total Joint Orthopedics, Inc., Klassic® Knee System (K180159,
March 9, 2018), hereafter referred to as "TJO Klassic Knee." |
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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 and orange below it. The "CON" is in black, and the "FORMIS" is in orange.
510K SUMMARY (page 2 of 5)
Conformis iTotal Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS), K161668, cleared July 15, 2016
Device Description: The iTotal Identity® Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal Identity CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal Identity CR KRS is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components.
Using patient imaging and a combination of proprietary and off the shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE), and either one or two polyethylene inserts. These inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked Vitamin E infused polyethylene). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the primary predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity CR KRS 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® Cruciate Retaining (CR) Knee Replacement System (KRS) 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.
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Image /page/5/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 four letters of the word are in black, while the last four letters are in orange. The logo is simple and modern, and it is likely used to represent the company's brand.
510K SUMMARY (page 3 of 5)
- 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.
Summary of Technological Characteristics: The rationale for substantial equivalence is based on consideration of the following device use and characteristics
Intended Use:
The proposed iTotal Identity CR KRS and predicate devices are intended to be used as total knee replacements. The implantable components are intended for single-use only in a single patient.
Indications for Use:
The proposed iTotal Identity CR KRS and the primary predicate iTotal CR KRS have identical indications for use.
Operating Principal/Fundamental Technology:
The proposed and predicate devices are semi-constrained, cemented knee implants that consist of three primary components; femoral, tibial, and patellar.
Single-use, patient-specific ancillary surgical instruments are provided for use with both the primary predicate iTotal CR KRS and proposed iTotal Identity CR KRS to assist with surgical implantation.
Reusable ancillary surgical instruments, provided in a reusable instrument tray, are used with the predicate and proposed devices. These instruments assist with surgical implantation.
Design:
The proposed and predicate devices have the same basic design characteristics as they are comprised of three primary components: femoral, tibial, and patellar. The proposed iTotal ldentity CR KRS offers a tibial tray stem extension and tibial tray keel cap, which are features that are also offered with the predicate TJO Klassic Knee.
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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 below it. The letters "O", "R", and "M" in the word "CONFORMIS" are orange, while the rest of the letters are black.
510K SUMMARY (page 4 of 5)
Materials:
The same biocompatible materials (CoCrMo, UHMWPE, and iPoly®XE) are used to manufacture the femoral, tibial insert, and patellar components of both the proposed iTotal Identity CR KRS and primary predicate iTotal CR KRS.
Titanium alloy (Ti6AL4V-ELI), is used to manufacture the tibial tray and tibial stem extension of the proposed iTotal Identity CR KRS. The tibial tray and stem extension of the predicate TJO Klassic Knee are also manufactured from titanium alloy (Ti6AL4V).
The tibial tray keel cap of the proposed iTotal Identity CR KRS is made from the same biocompatible material (UHMWPE) that is currently used to manufacture tibial inserts and patellar implants of the primary predicate device.
The same biocompatible materials (nylon, stainless steel and R-Radel) are used to manufacture the single-use and reusable surgical instrumentation of both the primary predicate and proposed iTotal Identity CR KRS.
Sterilization:
The implant components of both the proposed iTotal Identity CR KRS and predicate devices are provided sterile in double pouches (SAL 1.0 x 10-6).
The single-use surgical instruments used with the proposed and primary predicate device are provided sterile in double pouches (SAL 1.0 x 10-6).
The reusable surgical instruments used with the proposed and predicate devices are provided non-sterile.
Substantial The iTotal Identity CR KRS, subject of this premarket notification, is substantially equivalent to the following Equivalence predicate devices:
Conformis iTotal CR KRS (K180906. cleared May 16, 2018).
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Image /page/7/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 below it. The first part of the word, "CON," is in black, while the second part, "FORMIS," is in orange.
510K SUMMARY (page 5 of 5)
Conformis iTotal PS KRS (K161668, cleared July 15, 2016)
TJO Klassic Knee Svstem (K180159, cleared March 9, 2018)
Substantial equivalence is based on intended use and the technological characteristics of the proposed iTotal Identity CR KRS, as well as non-clinical testing conducted to confirm that proposed iTotal Identity CR KRS is substantially equivalent to the predicate devices. Specifically, the following testing was performed:
- Cadaver (instrumentation testing & usability) ●
- Insert interlock/Modularity
- Tibial tray stem fatigue
- Tibial tray stem assembly/disassembly ● torque
- Tibial tray and stem extension particle ● analysis/fretting corrosion
- Biocompatibility
- MRI Compatibility ●
- Patella test justification
- Tibial Insert justification (contact area, range of motion, constraint testing).
- . Sterilization validation
- . Reusable instrument cleaning & sterilization (new tray and new instruments)
All testing has demonstrated that the proposed iTotal Identity CR KRS is substantially equivalent to the predicate devices.
Conclusion Based on intended use, technological characteristics, and testing conducted, it is concluded that the proposed iTotal Identity CR KRS is substantially equivalent to the predicate devices.