(78 days)
No
The summary describes software used for patient-specific design based on imaging, but there is no mention of AI or ML algorithms being used in this process. The focus is on proprietary and off-the-shelf software for geometric and anatomical requirements.
Yes
The device is a knee replacement system intended to treat painful joint disease and post-traumatic loss of joint function, which are conditions that benefit from therapeutic intervention.
No
The device is a knee replacement system intended for surgical implantation, which is a therapeutic function, not a diagnostic one. While it uses imaging for design, it does not diagnose medical conditions.
No
The device description clearly states that the system includes physical components such as a femoral component made of CoCrMo alloy, a tibial component with a metal tray and polyethylene inserts, and a patellar component made of UHMWPE. While software is used in the design process, the final device is a physical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The iTotal® CR Knee Replacement System is a surgical implant intended for use within the human body to replace a damaged knee joint. It is a physical device implanted during surgery.
- Intended Use: The intended use is to replace a knee joint in patients with pain and disability. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- No Mention of Specimen Analysis: The description focuses on the implant itself, the surgical instruments, and the process of designing the implant based on imaging. There is no mention of analyzing any biological specimens.
The device utilizes imaging (CT or MR scans) and software for patient-specific design, but this is for the purpose of creating a customized implant for surgical implantation, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, 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 implant is intended for cemented use only.
Product codes
JWH, OOG
Device Description
The iTotal Cruciate Retaining 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.
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 quiding 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 510k i.e. K094050, K103117, K112780, K120068, K113378 and K120316.
Mentions image processing
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software, a patient-specific implant and related instrumentation are designed that best meet the geometric and anatomic requirements of the specific patient.
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)
K094050, K103117, K112780, K113378, K120068, K120316
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K122033('/6
2017
5.0 510(K) SUMMARY:
Page 1 of 6
| Submitter's Name
and Address | ConforMIS Inc.
11 North Ave.
Burlington, MA 01803 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number | 3004153240 and 3008690421 |
| Date of Summary | June 9, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and Regulatory
Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (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 |
| Regulation Number | 21 CFR 888.3560 |
| Device
Classification | Product Code:
JWH, Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
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. |
1
510(k) Summary continued Page 2 of 6 Indications for Use The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, 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 implant is intended for cemented use only ConforMIS iTotal CR Knee Replacement System (KRS) ldentification of the Device Class: Legally Marketed ll JWH, OOG Device Product Code: (Predicate Device) Requlation Number: 21 CFR 888.3560 K094050, K103117, K112780, K113378, 510(k) number: K120068, K120316
2
510(k) Summary continued Page 3 of 6
The iTotal Cruciate Retaining Knee Replacement System (hereafter Device Description referred to as the "iTotal CR KRS") is a patient-specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software, a patient-specific implant and related instrumentation are designed that best meet the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient-specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in quiding 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 510k i.e. K094050, K103117, K112780, K120068, K113378 and K120316.
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, K103117 cleared January 7, 2011, K112780 cleared December 15, 2011, K120068 cleared February 3, 2012, K113378 cleared February 15, 2012 and K120316 cleared April 19, 2012) The following testing was performed to establish substantial equivalence:
- Software verification and validation testing of proprietary t software iTotal iView
3
510(k) Summary continued Page 4 of 6
Device Comparison
| Characteristic | Modified iTotal CR KRS (This submission) | Predicate iTotal CR KRS (K112780 and
K120316) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The iTotal® CR Knee Replacement System is
intended for use as a total knee replacement
in patients with knee joint pain and disability
whose conditions cannot be solely addressed
by the use of a prosthetic device that treats
only one or two of the three knee
compartments, such as a unicondylar, 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 Knee Replacement System is
intended for use as a total knee replacement
in patients with knee joint pain and disability
whose conditions cannot be solely addressed
by the use of a prosthetic device that treats
only one or two of the three knee
compartments, such as a unicondylar, 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 implant is intended for cemented use only | The implant is intended for cemented use only | The implant is intended for cemented use only |
| Intended for Cement
Use Only | Yes | Yes |
| Product
Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Components | • Femoral Component
• Metal Backed Tibial Component
• Patellar Component | • Femoral Component
• Metal Backed Tibial Component
• Patellar Component |
| Materials | • Femoral Implant- CoCrMo
• Metal-Backed Tibial Components:
◦ Tibial tray- CoCrMo
◦ Tibial Insert-UHMWPE
• Patellar Component: UHMWPE | • Femoral Implant- CoCrMo
• Metal-Backed Tibial Components:
◦ Tibial tray- CoCrMo
◦ Tibial Insert-UHMWPE
• Patellar Component: UHMWPE |
| Characteristic | Modified iTotal CR KRS (This submission) | Predicate iTotal CR KRS (K112780 and
K120316) |
| Design | Knee joint patellofemorotibial semi - constrained cemented prosthesis | Knee joint patellofemorotibial semi - constrained cemented prosthesis |
| Configuration-
Femoral Implant | Constant coronal curvature Patient-specific sagittal J- curves | Constant coronal curvature Patient-specific sagittal J- curves |
| Tibial Implant | Configuration: Metal Backed Tibial
Implant Single or Dual inserts Insert sizes:6-16mm Articulating Surface: curved Profile: patient-specific Tray interlock: Interference fit Anterior lip Tray undercut design | Configuration: Metal Backed Tibial
Implant Single or Dual inserts Insert sizes:6-16mm Articulating Surface: curved Profile: patient-specific Tray interlock: Interference fit Anterior lip Tray undercut design |
| Patellar Implant | Symmetrical, offered in sizes ranging from 32,
35, 38, 41 and 44 mm, with corresponding
heights of 6, 7, 8.5, 10 and 12mm. | Symmetrical, offered in sizes ranging from 32,
35, 38, 41 and 44 mm, with corresponding
heights of 6, 7, 8.5, 10 and 12mm. |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Principle of
Operation | Cemented use
Fixed Bearing Design | Cemented use
Fixed Bearing Design |
| Posterior Cruciate
Ligament (PCL)
Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| 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 |
| Patient-specific
surgical plan | Generated by iTotal iView software or
manually generated | Manually generated |
| Sterility Method/
Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 |
| Initial Shelf-Life | 6 months | 6 months |
| Labeled Non-
pyrogenic | No | No |
4
510(k) Summary continued Page 5 of 6
.
5
510(k) Summary continued 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 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and | |
| Performance | The determination of substantial equivalence for this device was based
on a detailed device description. Non-clinical laboratory testing was
performed demonstrating that the device is safe and can be considered
substantially equivalent to the predicate device for the intended use.
Clinical data is not necessary to demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted, it is concluded that the iTotal Cruciate
Retaining Knee Replacement System with the use of the iTotal iView
production software is substantially equivalent to the iTotal Cruciate
Retaining Knee Replacement System (K094050 cleared September 16,
2010, K103117 cleared January 7, 2011, K112780 cleared Dec 15,
2011, K120068 cleared on February 3, 2012 and K113378 cleared on
February 15, 2012 and K120316 cleared April 19, 2012. |
·
.
·
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
2 7 2012
Conformis, Incorporated
% Ms. Amita S. Shah
Vice President, Quality Assurance and Regulatory Affairs
11 North Ave
Burlington, Massachusetts 01803
Re: K122033
Trade/Device Name: ConforMIS® iTotal Cruciate Knee Replacement System (iTotal CR KRS)
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: JWH, OOG Dated: July 9, 2012
Received: July 16, 2012
Dear Ms. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
7
Page 2 - Ms. Amita S. Shah
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
K122033 510(k) Number (if known):
Device Name:
ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Indications for Use:
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, 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, hemiatthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants.
The implant is intended for cemented use only.
Adf
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122033
Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (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)
Traditional 510(k) - Modified iTotal® CR Knee Replacement System - iTotal iView