(40 days)
Not Found
Unknown
The summary mentions "proprietary and offthe-shelf software" used with patient imaging to design a patient-specific implant. While this process involves software and image processing, the summary does not explicitly state whether this software utilizes AI or ML algorithms. The description of performance studies only mentions "Software verification and validation testing of proprietary software," which is not specific enough to confirm the presence of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as a total knee replacement in patients with knee joint pain and disability". Replacing a damaged joint to alleviate pain and restore function is a therapeutic intervention.
No
Explanation: This device is a knee replacement system, which is a prosthetic device implanted in a patient. It is not used to diagnose a condition.
No
The device description clearly states that the iTotal CR KRS is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system consisting of femoral, tibial, and patellar components made of CoCrMo alloy and polyethylene. 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:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The iTotal 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 is to treat knee joint pain and disability by replacing the joint with a prosthetic device. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
- Mentions of Imaging: While the device uses patient imaging to design the implant, this imaging is used for planning and manufacturing the physical implant, not for analyzing a biological specimen for diagnostic purposes.
Therefore, the iTotal CR Knee Replacement System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The iTotal 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY
Device Description
The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component.
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 implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal 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.
The function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for its intended use. The following non-clinical laboratory testing was performed: Software verification and validation testing of proprietary software.
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 16, 2018
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. Emmanuel Nyakako Sr. Vice President, Quality and Regulatory 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821
Re: K180906
Trade/Device Name: Conformis iTotal Cruciate Retaining (CR) 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: April 4, 2018 Received: April 6, 2018
Dear Emmanuel Nyakako:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180906
Device Name
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Indications for Use (Describe)
The iTotal 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 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.
| 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
510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name and
Address: | Conformis, Inc.
600 Technology Park Dr.
Billerica, MA 01821 | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment
Registration Number: | 3009844603 and 3004153240 | |
| Date 510(k) Summary
was Prepared: | April 4, 2018 | |
| Contact Person: | Emmanuel O. Nyakako, Sr. Vice President, Quality and
Regulatory | |
| Telephone Number:
Fax Number: | (781) 345-9164
(781) 345-0147 | |
| Name of the Device(s): | Conformis® iTotal® Cruciate Retaining Knee Replacement
System (iTotal CR KRS) | |
| Common Name(s): | Knee Replacement System | |
| Regulatory Status and
Regulation Number: | Class II
21 CFR 888.3560 | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis | |
| Device Classification: | Product Codes:
JWH: Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis.
OOG: Knee Arthroplasty Implantation System.
Intended to be used to assist in the implantation of a specific knee
arthroplasty device or a set of specific knee arthroplasty devices.
Indicated to include guiding alignment, making or establishing
cuts, selecting, sizing, attaching, positioning or orienting implant
components.
OIY: Prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer + additive/metal/polymer + additive. This
generic type of device includes prostheses that have a femoral
implant made of alloys, such as cobalt-chromium-molybdenum,
and a tibial component(s) and/or a retropatellar resurfacing
component made of ultra-high molecular weight polyethylene
plus an additive, such as a-tocopherol. | |
| Indications for Use: | The iTotal 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.
• 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. | |
| Identification of the | Conformis iTotal CR Knee Replacement System (iTotal CR
KRS) | |
| Legally Marketed | | |
| Device(s) (Predicate | Device Class: II | |
| Device(s)): | Product Code: JWH, OOG, OIY | |
| | Regulation Number: 21 CFR 888.3560 | |
4
510(K) SUMMARY (PAGE 2 OF 5)
510(k) Number:
5
510(K) SUMMARY (PAGE 3 OF 5)
Device Description: The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component.
Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal 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.
The function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.
6
510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The proposed iTotal CR KRS and predicate iTotal CR KRS have the same technological characteristics. There have been no changes to the proposed iTotal CR KRS device with respect to design, materials or methods of manufacture, packaging, or sterilization.
Modifications, which represent improving manufacturing efficiencies, are primarily focused on increasing automation of the CAD manufacturing processes via the proprietary software modules as shown in Table 8-1 below.
| Characteristic | Predicate
iTotal CR KRS
(K161366) | Proposed
iTotal CR KRS |
|---------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Generation of
Femoral Implant | iTotalWorks 5.1 and
Fem Addin or
Manual CAD
Process | iTotalWorks 6.0 &
iTotalFem CR 1.0 or
Manual CAD
Process |
| Generation of
Femoral iJigs | iTotalWorks 5.1 &
iTotal FemJigs 3.0
or Manual CAD
Process | iTotalWorks 6.0 and
iTotalFem CR 1.0 or
Manual CAD
Process |
| Generation of Tibial
Implants and iJigs | iTotalTib CR 4.3 or
Manual CAD
Process | iTotalTib CR 5.0 or
Manual CAD
Process |
| Generation of
Patient-Specific
Surgical Plan
(iView) | iTotal CR iView 3.0
or Manual CAD
Process | iTotal CR iView 4.0
or Manual CAD
Process |
Table 8-1: Comparison Between the Proposed and Predicate Device
7
510(K) SUMMARY (PAGE 5 OF 5)
| Substantial Equivalence: | The determination of substantial equivalence for this device was
based on a detailed device description. Non-clinical laboratory
testing was performed demonstrating that the device can be
considered substantially equivalent to the predicate device for its
intended use. The following non-clinical laboratory testing was
performed:
Software verification and validation testing of
proprietary software |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the testing conducted, it is concluded that the proposed |
iTotal Cruciate Retaining Knee Replacement System is substantially equivalent to the predicate iTotal Cruciate Retaining Knee Replacement System (K161366, cleared June 14, 2016).