(42 days)
Not Found
Unknown
The description mentions using proprietary and off-the-shelf software with patient imaging to design a patient-specific implant. While this process could potentially involve AI/ML for image analysis or design optimization, the summary does not explicitly state the use of these technologies. The focus is on patient-specific design and manufacturing based on imaging, which can be achieved through traditional software and algorithms.
Yes
The device is a knee replacement system intended to treat painful joint disease and restore joint function in patients, which aligns with the definition of a therapeutic device.
No
The device is a knee replacement system intended for surgical implantation to treat knee joint pain and disability, not for diagnosing conditions.
No
The device description clearly states that the iTotal CR KRS is a patient-specific tricompartmental knee replacement system consisting of physical components (femoral, tibial, and patellar components made of 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The iTotal CR Knee Replacement System is a surgical implant designed 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 implant itself, the materials used, and the surgical instruments for implantation. There is no mention of collecting or analyzing biological samples.
Therefore, the iTotal CR 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 (iTotal CR 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 liqament (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 UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™). The patellar component is also manufactured from 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 surqical 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 intraoperatively and quiding the cutting of bone.
The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K120316 and 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:
- . Tibial interlock assembly and disassembly testing
- . Contact area/contact stress testing
- Constraint testing .
- . 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.
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
K131019 (1/6)
.
.
8.0 510(K) SUMMARY
.
· MAY 2 4 2013
| Submitter's Name
and Address | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number | 3009844603 |
| Date of Summary | April 11, 2013 |
| Contact Person | Amita S. Shah, 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 |
| 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. |
Special 510(k) – Modified iTotal® CR Knee Replacement System
・・
1
510(K) SUMMARY CONTINUED
Indications for Use
The iTotal® CR Knee Replacement System (iTotal CR 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: Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) number: K120316 and K122870
2
510(K) SUMMARY CONTINUED
Device Description
The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate liqament (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 UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™). The patellar component is also manufactured from 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 surqical 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 intraoperatively and quiding the cutting of bone.
The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K120316 and K122870.
The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K120316 cleared April 19, 2012 and K122870 cleared January 14, 2013) and other currently marketed, cemented total knee replacement systems. The following testing was performed to establish substantial equivalence:
- Tibial interlock assembly and disassembly testing -
- -Contact area/contact stress testing
- Constraint testing -
- Design validation via cadaveric testing -
Substantial Equivalence
Special 510(k) - Modified iTotal® CR Knee Replacement System
29
3
.
510(K) SUMMARY CONTINUED
Device Comparison
1
| Attribute | Predicate
iTotal CR Knee Replacement System
(K120316 and 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 Single or dual Tibial Inserts:
UHMWPE or iPoly XE
(highly cross-linked Vitamin
E infused polyethylene) All Polymer Patellar Component:
UHMWPE or iPoly XE (highly cross-
linked Vitamin E infused
polyethylene) | Femoral Implant: CoCrMo Metal Backed Tibial Components: Tibial tray: CoCrMo Single or dual Tibial Inserts:
UHMWPE or iPoly XE
(highly cross-linked Vitamin
E infused polyethylene) All Polymer Patellar Component:
UHMWPE or iPoly XE (highly
cross-linked Vitamin E infused
polyethylene) |
| 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 |
| Patient
Matched | Yes | Yes |
| Patellar Design/
Dimensions | Symmetrical, offered in various sizes | Symmetrical, offered in various sizes |
| Tibial Implant
interlock
design | Interference fit Anterior lip Undercuts on medial and lateral
sides with Central Spine Full Posterior Scallops on Tray,
Step-Up on Inserts Insert Snap Features | Interference fit Anterior lip Increased undercuts on medial and
lateral sides with Central Spine Reduced Posterior Scallops on
Tray, Step-Up Removed on Inserts Increased Insert Snap Width
Features |
| Tibial Slope | Fixed at 5 degrees | Fixed at 5 degrees or cut option of
patient specific tibial slope |
| Minimum
Thickness of
Tibial Insert
(UHMWPE) | 6 mm | 6 mm |
| Attribute | Predicate
iTotal CR Knee Replacement System
(K120316 and K122870) | Modified Device
iTotal CR Knee Replacement System
(This submission) |
| Posterior
Cruciate
Ligament (PCL)
Sparing | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
:
4
:
:
.
.
.
.
5
510(K) SUMMARY CONTINUED
Description and Conclusion of Testing
Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use:
- . Tibial interlock assembly and disassembly testing
- . Contact area/contact stress testing
- Constraint testing .
- . Cadaveric testing
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
Safety and Performance
Based on the testing conducted it is concluded that the modified device is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System, K120316 cleared April 19, 2012 and K122870 cleared on January 14, 2013.
Special 510(k) - Modified iTotal® CR Knee Replacement System
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 24, 2013
ConforMIS, Incorporated % Ms. Amita Shah Vice President and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K131019
Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: May 13, 2013 Received: May 14, 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
7
Page 2 - Ms. Amita 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 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erin Dkeith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _K131019
Device Name: iTotal CR Knee Replacement System
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, 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.
The 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/8/Picture/14 description: The image shows the words "Casey L. Hanley, Ph.D." on the top line, followed by a horizontal line. The second line says "Division of Orthopedic Devices". The text is in a simple, sans-serif font and appears to be part of a letterhead or official document.
Special 510(k) - Modified iTotal® CR Knee Replacement System