(98 days)
Not Found
Unknown
The summary mentions "proprietary and off the shelf software" used in conjunction with patient imaging to design a "patient specific implant." While this process involves complex algorithms and potentially sophisticated image processing, the summary does not explicitly state or provide details that confirm the use of AI or ML. The focus is on patient-specific design based on imaging, which could be achieved through traditional computational methods.
Yes
The device is a knee replacement system intended to treat painful joint diseases and post-traumatic loss of joint function, which are therapeutic indications.
No
Explanation: This device is a total knee replacement system; its purpose is to replace the knee joint, not to diagnose a condition. While it utilizes patient imaging (CT or MR scans) for design, this is for manufacturing a patient-specific implant, not for diagnosis.
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 materials like 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:
- Intended Use: The intended use is for a total knee replacement in patients with knee joint pain and disability. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a knee replacement system consisting of femoral, tibial, and patellar components. These are physical implants designed to replace parts of the knee joint.
- Function: The function is to replace the knee joint, not to perform diagnostic tests on biological samples.
- Input: While it uses patient imaging (CT or MR scans) to design the patient-specific implant, this imaging is used for planning and manufacturing the implant, not for in vitro diagnostic testing.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids or substances. This device is a surgical implant.
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.
- 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 (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. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
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 the cutting of bone.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K131467 and K131019.
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 iTotalWorks Detailed software description and software verification and validation testing of proprietary software iTotal FemJigs Detailed software description and software verification and validation testing of proprietary software iTotalTib Detailed software description and software verification and validation testing of proprietary software iTotal TibJigs Detailed software description and software verification and validation testing of proprietary software iTotal iView Design validation via cadaveric testing.
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.
K131467, K131019, K122991, K122033, K120068
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
K140423 (page 1/6)
MAY 2 7 2014
| 6.0 510(K) SUMMARY (PAGE 1 OF 6) | MAY 27 20 |
|---|---|
| ---------------------------------- | ----------- |
| Submitter's Name and Address: | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3009844603 and 3004153240 |
| Date of Summary: | February 11, 2014 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number: | (781) 345-9164 |
| Fax Number: | (781) 345-0147 |
| Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) |
| Common Name: | Cruciate Retaining 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 Code:
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 prosthesis that have a femoral component 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. |
:
1 of 6
1
510(K) SUMMARY (PAGE 2 OF 6)
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.
- · 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.
ldentification of the Legally Marketed Device (Predicate Device):
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: = JWH, OOG, OIY Product Code: Regulation Number: 21 CFR 888.3560 510(k) Number: K131467, K131019, K122991, K122033, and K120068
2
510(K) SUMMARY (PAGE 3 OF 6)
| 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 (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. The
polyethylene inserts may be manufactured from either UHMWPE or
a highly cross-linked Vitamin E infused polyethylene (iPoly XE™)
The patellar component is also manufactured from either UHMWPE
or from a highly cross-linked Vitamin E infused polyethylene (iPoly
XE™).
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 the cutting of bone.
The function and general design features of the patient specific
implants and ancillary instruments remain similar to those
described in the predicate 510(k)'s K131467 and K131019. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | The product subject of this premarket notification is substantially
equivalent to the iTotal CR KRS (K131467, cleared July 18, 2013;
K131019, cleared May 24, 2013; K122991, cleared December 20,
2012; K122033, cleared September 27, 2012 and K120068,
cleared February 3, 2012). The following testing was performed to
establish substantial equivalence:
Software verification and validation testing of proprietary |
-
Software verification and validation testing of proprietary software
. -
Design validation via cadaveric testing .
•
45
.
3 of 6
.
.
3
510(K) SUMMARY (PAGE 4 OF 6)
Device Comparison
| Characteristic | Predicate
iTotal Cruciate Retaining Knee
Replacement System
(K131467, K131019, K122991, K122033 &
K120068) | iTotal Cruciate Retaining Knee
Replacement System
(This submission) |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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.
• 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. | 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.
• 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. |
| Principle of
Operation | Cemented Use Fixed Bearing Design | Cemented Use Fixed Bearing Design |
| Product
Classification | 21 CFR 888.3560 (JWH, OOG, OIY) | 21 CFR 888.3560 (JWH, OOG, OIY) |
| Components and
Materials | • Femoral Implant: CoCrMo
• Metal Backed Tibial Components:
o Tibial tray: CoCrMo
o Tibial dual or single piece
inserts: UHMWPE or iPoly XE
• All Polymer Patellar Component:
UHMWPE or iPoly XE | • Femoral Implant: CoCrMo
• Metal Backed Tibial Components:
o Tibial tray: CoCrMo
o Tibial dual or single piece
inserts: UHMWPE or iPoly XE
• All Polymer Patellar Component:
UHMWPE or iPoly XE |
| Characteristic | Predicate
iTotal Cruciate Retaining Knee
Replacement System
(K131467, K131019, K122991, K122033 &
K120068) | iTotal Cruciate Retaining Knee
Replacement System
(This submission) |
| Design | Knee joint patellofemorotibial semi-
constrained cemented prosthesis | Knee joint patellofemorotibial semi-
constrained cemented prosthesis |
| Patient Matched | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| Proprietary
Software for
Femoral
Components | iTotalWorks version 4.0 or Manual Process | iTotalWorks version 5.0 or Manual Process |
| Proprietary
Software for the
Femoral iJigs | iTotal FemJigs version 1.5 or Manual Process | iTotal FemJigs version 2.0 or Manual Process |
| Proprietary
Software for Tibial
Components | iTotalTib version 1.0 or Manual Process | iTotalTib version 2.0 or Manual Process |
| Proprietary
Software for Tibial
iJigs | N/A - Manual Process | iTotal TibJigs version 1.0 or Manual Process |
| Proprietary
Software for
Patient-Specific
Surgical Plan | iTotal iView version 1.0 or Manual Process | iTotal iView version 2.0 or Manual Process |
1
.
4
510(K) SUMMARY (PAGE 5 OF 6)
Device Comparison
5
510(K) SUMMARY (PAGE 6 OF 6)
| 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 iTotalWorks Detailed software description and software verification and
validation testing of proprietary software iTotal FemJigs Detailed software description and software verification and
validation testing of proprietary software iTotalTib Detailed software description and software verification and
validation testing of proprietary software iTotal TibJigs Detailed software description and software verification and
validation testing of proprietary software iTotal iView Design validation via cadaveric testing |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
iTotal CR KRS is substantially equivalent to the predicate iTotal CR
KRS (K131467 cleared July 18, 2013, K131019 cleared May 24,
2013, K122991 cleared December 20, 2012, K122033 cleared
September 27, 2012, and K120068 cleared February 03, 2012) |
.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2014
ConforMIS. Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford. Massachusetts 01730
Re: K140423
Trade/Device Name: 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 23, 2014 Received: April 24, 2014
Dear Ms. Shalı:
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 tiability 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 (reporting of medical
7
Page 2 - Ms. Amita Shah
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
K140423 510(k) Number (if known): _
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, 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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices