(100 days)
No
The description mentions using software for patient-specific design based on imaging, but there is no explicit mention of AI or ML being used in this process. The software testing listed is for specific proprietary software names, not general AI/ML frameworks.
No
The device is a knee replacement system intended to replace painful and disabled knee joints, which is a prosthetic device. Therapeutic devices are typically those that administer treatment directly or affect a change in the body's function, not replacements.
No
Explanation: The device is described as a knee replacement system, which is a prosthetic device intended for treatment, not for diagnosing medical conditions. While it uses patient imaging for design, its purpose is implantation, not diagnosis.
No
The device description clearly states that the iTotal® KRS are patient specific tricompartmental faceted knee replacement systems, which are physical implants made of materials like CoCrMo alloy and polyethylene. While software is used in the design process, the device itself is a physical implant and associated surgical instruments.
Based on the provided text, 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 Description: The iTotal CR/PS Knee Replacement System is a surgical implant intended to replace a damaged knee joint. It is a physical device implanted into the patient's body.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint, not by analyzing samples from the body.
- No Mention of Samples: The description focuses on the design and implantation of the prosthetic device, with no mention of testing biological samples.
Therefore, the iTotal CR/PS Knee Replacement System falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The iTotal 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 o 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® Knee Replacement Systems (hereafter referred to as the "iTotal® KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.
Using patient imaging and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral 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 (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, a highly cross-linked Vitamin E infused polyethylene (iPoly XETM) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XETM).
For user convenience, and similar to the predicate iTotal KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal® 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 K140423 and K140833.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing of proprietary software: SegSurf(T), iTotal FemJigs, iTotalTib, iTotal TibJigs, iTotal iView. The conclusion was that the modified iTotal KRS are substantially equivalent to the predicate iTotal® KRS.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three interconnected profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
ConforMIS Incorporated Ms. Amita S. Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K142161
Trade/Device Name: ConforMIS iTotal Cruciate Retaining Knee Replacement System (iTotal CR KRS) ConforMIS iTotal Posterior Stabilized Knee Replacement System (iTotal PS 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, OIY Dated: October 14, 2014 Received: October 15, 2014
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
1
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 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/Resourcesfor You/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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
ConforMIS iTotal Cruciate Retaining Knee Replacement System (iTotal CR KRS)
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 o 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 Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 2
3
Indications for Use
510(k) Number (if known): _ K142161
Device Name:
ConforMIS iTotal Posterior Stabilized Knee Replacement System (iTotal PS KRS)
Indications for Use:
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- . Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental . implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and o positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)# Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
4
510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name and
Address: | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3009844603 and 3004153240 |
| Date of Summary: | July 31, 2014 |
| Contact Person:
Telephone Number:
Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs
(781) 345-9164
(781) 345-0147 |
| Name of the
Device(s): | ConforMIS iTotal® Cruciate Retaining Knee Replacement System
(iTotal CR KRS)
ConforMIS iTotal® Posterior Stabilized Replacement System
(iTotal PS KRS) |
| Common Name(s): | Cruciate Retaining Knee Replacement System
Posterior Stabilized 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 prostheses 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 |
5
510(K) SUMMARY (PAGE 2 OF 5)
Indications for Use:
iTotal® CR KRS
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.
iTotal® PS KRS
The iTotal PS 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, polyarthritis or osteonecrosis of the knee.
- · Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity. .
- · 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.
6
510(K) SUMMARY (PAGE 3 OF 5)
| Identification of the
Legally Marketed
Device(s) (Predicate
Device(s)): | ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS)
ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS) | | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--|
| | Device Class:
Product Code:
Regulation Number:
510(k) Number:
Device Class: | II
JWH, OOG, OIY
21 CFR 888.3560
K140423 and K140833
II | |
| Device Description: | The iTotal® Knee Replacement Systems (hereafter referred to as the "iTotal® KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components. | | |
| | Using patient imaging and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral 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 (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, a highly cross-linked Vitamin E infused polyethylene (iPoly XETM) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XETM). | | |
| | For user convenience, and similar to the predicate iTotal KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal® 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 K140423 and K140833. | | |
7
510(K) SUMMARY (PAGE 4 OF 5)
| Substantial
Equivalence: | The products subject of this premarket notification are substantially
equivalent to the iTotal CR KRS (K140423, cleared May 27, 2014)
and the iTotal PS KRS (K140833, cleared June 30, 2014). The
following testing was performed to establish substantial
equivalence:
• Software verification and validation testing of proprietary
software | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Description and
Assessment
Nonclinical Testing: | The modified iTotal KRS and predicate iTotal KRS have the same
technological characteristics. There have been no changes to the
modified iTotal KRS devices with respect to design, materials, and
methods of manufacture, packaging, or sterilization. The designs of
the devices remain similar to those cleared via K140423 and
K140833. | |
| | Modifications which represent improving manufacturing efficiencies
are primarily focused on increasing automation of the CAD
manufacturing process via the proprietary software modules as
shown in Table 1 below.
Table 1: Comparison between the Modified and Predicate
Devices | |
| | Predicate
iTotal Knee Replacement
Systems | Modified iTotal Knee
Replacement Systems
(This submission) |
| | (K140423 and K140833) | |
| | SegSurf(T) version 2.6 or
Manual Process | SegSurf(T) version 3.0 or
Manual Process |
| | iTotal FemJigs version 2.0 (CR
only) or Manual Process | iTotal FemJigs version 3.0 or
Manual Process |
| | iTotalTib version 2.1 (CR only)
or Manual Process | iTotalTib version 3.0 (CR only)
or Manual Process |
| | iTotal TibJigs version 1.1 (CR
only) or Manual Process | iTotal TibJigs version 2.0 (CR
only) or Manual Process |
| | iTotal iView version 2.0 (CR
only) or Manual Process | iTotal iView version 3.0 (CR
only) or Manual Process |
8
510(K) SUMMARY (PAGE 5 OF 5)
| 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 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 Segsurf(T) 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 |
Based on the testing conducted, it is concluded that the modified iTotal KRS are substantially equivalent to the predicate iTotal® KRS (K140423 cleared May 27, 2014 and K140833 cleared June 30, 2014).
- 8