(58 days)
No
The description mentions "proprietary and off the shelf software" used with patient imaging to design a patient-specific implant, but it does not explicitly state or imply the use of AI or ML algorithms for this process. The focus is on patient-specific design and manufacturing, not on automated interpretation or decision-making based on AI/ML.
Yes
The device is a total knee replacement system intended to treat knee joint pain and disability, which aligns with the definition of a therapeutic device.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing medical conditions. It treats conditions rather than identifying them.
No
The device description clearly states that the iTotal CR Knee Replacement System includes physical components such as femoral, tibial, and patellar components made of CoCrMo alloy and polyethylene, as well as accessory surgical instruments. While software is used for patient-specific design, the device itself is a physical implant system.
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 to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is described as a patient-specific tricompartmental faceted posterior cruciate ligament (PCL) retaining 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) for design, this is for planning and manufacturing the physical implant, not for analyzing biological specimens.
IVD devices are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a surgical implant used to treat a physical condition.
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
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 indudes 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 marking of bone before cutting.
The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510(k) K122870.
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:
• Patella fixation testing
• Steam Sterilization Validation and Product Performance post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
8.0 510(K) SUMMARY
JUL 1 8 2013
| Submitter's Name
and Address | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|
| Establishment
Registration Number | 3009844603 |
| Date of Summary | July 17, 2013 |
| Contact Person | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0104 |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (iTotal CR
KRS) |
| Common or Usual
Name | Cruciate Retaining Total Knee Replacement System |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella
1
510(K) Summary Continued
| 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. |
| 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. |
!
2
.
510(K) SUMMARY CONTINUED
| Identification of the Legally Marketed Device
| (Predicate Device) | ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) |
|---|---|
| Device Class: | II |
| Product Code: | JWH, OOG, OIY |
| Regulation Number: | 21 CFR 888.3560 |
| 510(k) number: | K122870 |
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 indudes 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 marking of bone before cutting.
The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510(k) K122870.
3
510(K) SUMMARY CONTINUED
Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K122870 cleared January 14, 2013). The following testing was performed to establish substantial equivalence:
- Patella Fixation Testing -
- Steam Sterilization Validation and Product Performance for Metal Implants and iJig Instrumentation post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.
4
510(k) Summary continued
Device Comparison
| Attribute | Predicate
iTotal CR Knee Replacement
System
(K122870) | Modified Device
iTotal CR Knee Replacement
System
(This submission) | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Components | 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
or iPoly XE All Polymer Patellar Component:
UHMWPE or iPoly XE | Femoral Implant: CoCrMo Metal Backed Tibial
Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE
or iPoly XE All Polymer Patellar Component:
UHMWPE or iPoly XE | |
| 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 | |
| Attribute | Predicate
iTotal CR Knee Replacement
System
(K122870) | Modified Device
iTotal CR Knee Replacement
System
(This submission) | |
| 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. | 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. | |
| Patient Matched | Yes | Yes | |
| Attribute | Predicate
iTotal CR Knee Replacement
System
(K122870) | Modified Device
iTotal CR Knee Replacement
System
(This submission) | |
| Tibial Implant | Configuration: Metal Backed
Tibial ImplantTibial Insert - UHMWPE or
iPoly XESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific | Configuration: Metal Backed
Tibial ImplantTibial Insert - UHMWPE or iPoly
XESingle or Dual insertsInsert sizes: 6-16mmProfile: patient-specific | |
| Posterior
Cruciate
Ligament (PCL)
Sparing | Yes | Yes | |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | |
| Packaging | Device components are individually
double-pouched using Tyvek®/film
pouches which are sealed and
labeled | Device components are individually
double-pouched using Tyvek®/film
pouches which are sealed and
labeled | |
| Sterility Method/
Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 | |
| Instructions for
Intra-Operative
Sterilization | None | Steam Sterilization (SAL of 1x10-6) | |
| Initial Shelf-Life | 6 months | 6 months | |
| Labeled Non-
pyrogenic | No | No | |
| Patella Design
and Sizes
(diameter) | Symmetrical, offered in sizes: 32mm,
35mm, 38mm, 41mm, 44mm | Symmetrical, offered in sizes, 29mm,
32mm, 35mm, 38mm, 41mm, 44mm | |
| 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:
• Patella fixation testing
• Steam Sterilization Validation and Product Performance
post steam sterilization to support instructions provided for
sterilization of components in case of a loss of sterility. | | |
| 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 proposed 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 K122870 cleared January 14, 2013. | | |
:
Traditional 510(k) – Modified iTotal® CR Knee Replacement System – 29mm Patella
·
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5
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6
7
:
.
510(k) Summary continued
· .
.
.
.
8
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2013
ConforMIS, Incorporated % Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Boston, Massachusetts 01730
Re: K131467
Trade/Device Name: iTotal® CR Knee Replacement System (KRS) 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: May 31, 2013 Received: June 4, 2013
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
Image /page/8/Picture/11 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
9
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K131467
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.
| Prescription Use | X |
|---|---|
| (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)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131467
Special 510(k) - Modified ITotal® CR Knee Replacement System - 29mm Patella