(91 days)
Not Found
No
The summary describes patient-specific design based on imaging and proprietary software, but does not mention AI or ML. The software testing focuses on verification and validation, not performance metrics typical of AI/ML models.
Yes.
The device is a knee replacement system intended to alleviate pain and disability in patients with various knee joint conditions, which is a therapeutic purpose.
No
The device is a knee replacement system intended for surgical implantation to treat knee joint pain and disability, not for diagnosing conditions.
No
The device description clearly states that the iTotal CR Knee Replacement System is a physical implant consisting of femoral, tibial, and patellar components made of CoCrMo alloy and UHMWPE. While software is used in the design process, the device itself is a hardware implant.
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 Function: The iTotal® CR Knee Replacement System is a surgical implant used to replace a damaged knee joint. It is a physical device implanted into the patient's 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.
- Device Description: The description details the components of the implant (femoral, tibial, patellar components) and the materials used. This aligns with a surgical implant, not a diagnostic test kit or instrument.
- Input: While it uses patient imaging (CT or MR scans) for design, this imaging is used for planning and customizing the implant, not for analyzing biological samples for diagnostic purposes.
Therefore, the iTotal® CR Knee Replacement System falls under the category of a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
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 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 manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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.
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
K 113378 PAGE 1 OF 5
FEB 1 5 2012
8.0 510(K) SUMMARY
. : -- --
| Submitter's Name and
Address | ConforMIS Inc.
11 North Ave.
Burlington, MA 01803 |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number | 3004153240 |
| Date of Summary | November 14, 2011 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and
Regulatory 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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar,
patello-femoral or bi-compartmental implants.
The iTotal CR KRS 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
Regulation Number: 21 CFR 888.3560
510(k) number: K094050, K103117 |
| 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 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 manufactured
from CoCrMo alloy and either one or two polyethylene inserts
manufactured from UHMWPE of identical configuration. The
patellar component is manufactured from UHMWPE. |
| Substantial
Equivalence: | The product subject of this premarket notification is substantially
equivalent to the iTotal Cruciate Retaining Knee Replacement
System (K094050 cleared September 16, 2010 and K103117
cleared January 7, 2011). The following testing was performed to
establish substantial equivalence:
Software verification and validation testing of proprietary
software |
1
KII3378 PAGE 2 OF 5
510(k) Summary continued
.
·
:
2
510(k) Summary continued
Device Comparison
| | Predicate
iTotal CR Knee
Replacement System
K103117 | Predicate
iTotal CR Knee
Replacement System
K094050 | Modified Device
iTotal CR Knee
Replacement System |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Femoral
Component Tibial Implant Metal Backed Tibial
Component Patellar component | Femoral
Component Tibial Implant Metal Backed
Tibial Component Patellar component | Femoral
Component Tibial Implant Metal Backed
Tibial Component Patellar component |
| 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 | 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 | Knee joint
patellofemorotibial
semi-constrained
cemented prosthesis |
| Principle of
Operation | Cemented Use fixed
Bearing Design | Cemented Use fixed
Bearing Design | Cemented Use fixed
Bearing Design |
| Patient
Matched | Yes | Yes | Yes |
| Patellar
Design/
Dimensions | Symmetrical, offered in
various sizes | Symmetrical, offered in
various sizes | Symmetrical, offered in
various sizes |
| Minimum
Thickness of
Tibial Insert
(UHMWPE) | 6 mm | 6 mm | 6 mm |
| Posterior
Cruciate
Ligament
(PCL) Sparing | Yes | Yes | Yes |
| | Predicate
iTotal CR Knee
Replacement System
K103117 | Predicate
iTotal CR Knee
Replacement System
K094050 | Modified Device
iTotal CR Knee
Replacement System |
| Instrumentation
n | Patient specific Nylon
jigs | Patient specific Nylon
jigs | Patient specific Nylon
jigs |
| Software | SegSurf(T) version 1.1 | SegSurf(T) version 1.1 | SegSurf(T) version 2.0 |
3
K113378
PAGE 4 OF 5
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:
s
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4
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510(k) Summary continued
| Description and
Conclusion 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 |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 modified
device is substantially equivalent to the iTotal Cruciate Retaining
Knee Replacement System (K094050 cleared September 16, 2010
and K103117 cleared January 7, 2011). |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS, Incorporated % Ms. Amita Shah, RAC Vice President, Quality Assurance and Regulatory Affairs l l North Avenue Burlington, Massachusetts 01803
FEB 15 2012
Re: K113378
Trade/Device Name: iTotal CR Knee Replacement System 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 Dated: November 14, 2011 Received: November 16, 2011
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Ms. Amita Shah
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 vours.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): _if(33388
Device Name: iTotal CR Knee Replacement System
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, patello-femoral or bi-compartmental 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. o
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be t returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bio compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Katherin V. Cheney
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113378
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)