(85 days)
No
The description mentions proprietary software for patient-specific design based on imaging, but there is no mention of AI or ML algorithms being used in this process. The focus is on geometric and anatomical requirements and bone preservation.
Yes.
The device is a knee replacement system intended to treat conditions like painful joint disease, post-traumatic loss of joint function, and deformities, which are therapeutic interventions.
No
Explanation: The provided text describes the iTotal® CR Knee Replacement System, which is a prosthetic device intended for use as a total knee replacement. It is a treatment device, not a device used to diagnose a condition. While it utilizes patient imaging (CT or MR scans), these are used for designing the patient-specific implant and related instrumentation, not for diagnosing the knee joint pain and disability.
No
The device description explicitly states that the system includes physical components such as a femoral component (CoCrMo alloy), a tibial component (metal tray and polyethylene inserts), and a patellar component (UHMWPE). It also mentions accessory orthopedic manual surgical instruments. While software is used for design, the final product is a physical implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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 intended 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 bodily specimens.
- Input: While it uses imaging (CT or MR scans) for design, these are used for planning and creating the physical implant, not for analyzing biological samples.
Therefore, based on the provided information, the iTotal® CR Knee Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iTotal® 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. The implant is intended for cemented use only.
Product codes
JWH, OOG
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. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet 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 manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient-specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding of the cutting of bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging (either CT or MR scans)
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)
Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use: Detailed software description and software verification and validation testing of proprietary software iTotalWorks Detailed software description and software verification and validation testing of proprietary software iTotalTib
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K094050, K103117, K112780, K113378, K120068, K120316
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
5.0 510(K) SUMMARY (PAGE 1 OF 5)
.
:" :
DEC 2 0 2012
| Submitter's Name and
Address: | ConforMIS Inc.
11 North Avenue
Burlington, MA 01803 |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3004153240 |
| Date of Summary: | September 24, 2012 |
| Contact Person:
Telephone Number:
Fax Number: | Amita S. Shah, Vice President, Regulatory and Quality Affairs
(781) 345-9164
(781) 345-0104 |
| Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or Usual
Name: | Cruciate Retaining Total Knee Replacement
System |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Indications for Use: | The iTotal® 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. The implant is intended for cemented use only. |
| Identification of the
Legally Marketed
Device
(Predicate Device): | ConforMIS iTotal CR Knee Replacement System (KRS)
Device Class: II
Product Code: JWH, OOG
Regulation Number: 21 CFR 888.3560
510(k) Number: K094050, K103117, K112780, K113378,
K120068, and K120316 |
Traditional 510(k) — Modified iTotal® CR Knee Replacement System — lTotalTib v1.0/iTotalWorks v4.0
18
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1
1
510(K) SUMMARY (PAGE 2 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. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patientspecific implant and related instrumentation are designed, that best meet 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 manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient-specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding of the cutting of bone.
The function and general design features of the patient-specific ancillary instruments remain similar to those described in the predicate 510k notifications i.e. K094050, K103117, K112780, K113378, K120068, and K120316
The product subject of this premarket notification is substantially equivalent to the Total Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 07, 2011, K112780 cleared December 15, 2011, K113378 cleared February 15, 2012, K120068 cleared February 03, 2012, and K120316 cleared April 19, 2012. The following testing was performed to establish substantial equivalence:
- Software verification and validation testing of . proprietary software
Substantial
Equivalence:
2
510(K) SUMMARY (PAGE 3 OF 5)
:
Device Comparison
:
・
| Characteristic | Predicate
iTotal CR Knee Replacement
System
(K112780 & K120316) | Modified Device
iTotal CR Knee Replacement
System
(This submission) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The iTotal® CR 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. | The iTotal® CR 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. |
| | The iTotal KRS is intended for
cemented use only | The implant is intended for
cemented use only |
| Intended for
Cement Use
Only | Yes | Yes |
| Product
Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Components | • Femoral Component
• Metal Backed Tibial
Component
• Patellar component | • Femoral Component
• Metal Backed Tibial
Component
• Patellar component |
| Characteristic | Predicate
iTotal CR Knee Replacement
System
(K112780 & K120316) | Modified Device
iTotal CR Knee Replacement
System
(This submission) |
| Materials | Femoral Implant: CoCrMo
Metal Backed Tibial
Components:
Tibial tray: CoCrMo Tibial Inserts:
UHMWPE All Polymer Patellar
Component: UHMWPE | Femoral Implant: CoCrMo
Metal Backed Tibial
Components:
Tibial tray: CoCrMo Tibial Inserts:
UHMWPE All Polymer Patellar
Component: UHMWPE |
| Design | Knee joint patellofemorotibial semi-
constrained cemented prosthesis | Knee joint patellofemorotibial semi-
constrained cemented prosthesis |
| Principle of
Operation | Cemented Use fixed Bearing
Design | Cemented Use fixed Bearing
Design |
| Patient
Matched | Yes | Yes |
| Posterior
Cruciate
Ligament (PCL)
Sparing | Yes | Yes |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Proprietary
Software for
Femoral
Components | iTotalWorks version 3.0 | iTotalWorks version 4.0 |
| Proprietary
Software for
Tibial
Components | N/A - manual process | iTotalTib version 1.0 or manual
process |
/
.
.
20
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3
K122991
.
510(K) SUMMARY (PAGE 4 OF 5)
.
.
21
. .
:
4
.
510(K) SUMMARY (PAGE 5 OF 5)
| Description of
Testing: | Nonclinical Testing: The determination of substantial
equivalence for this device was based on a detailed device
description. The following non-clinical laboratory testing was
performed demonstrating that the device is safe and can be
considered substantially equivalent to the predicate device for
the intended use:
Detailed software description and software verification
and validation testing of proprietary software
iTotalWorks Detailed software description and software verification
and validation testing of proprietary software iTotalTib |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance: | 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 is safe and
can be considered substantially equivalent to the predicate
device for the intended use. Clinical data is not necessary to
demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iTotal
Cruciate Retaining Knee Replacement System with the use of
the iTotalWorks v4.0 and iTotalTib v1.0 production software is
substantially equivalent to the iTotal Cruciate Retaining Knee
Replacement System (K094050 cleared September 16, 2010,
K103117 cleared January 07, 2011 and K112780 cleared Dec
15, 2011, K113378 cleared February 15, 2012, K120068
cleared February 03, 2012, and K120316 cleared April 19,
2012) |
.
:
·
·
:
:
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22
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5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 20, 2012.
ConforMIS, Incorporated % Ms. Amita S. Shah Vice President, Regulatory and Quality Affairs 11 North Avenue Burlington, Massachusetts 01803
Re: K122991
Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II Product Code: JWH, OOG Dated: September 24, 2012 Received: September 26, 2012
Dear Ms. Shah:
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
6
Page 2 - Ms. Amita S. Shah
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson · Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K122991
Device Name:
ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Indications for Use:
The iTotal® CR 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, ucy 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.
The implant is intended for cemented use only
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi
Division of Orthopedic Devices