(78 days)
Not Found
No
The summary describes software used for patient-specific implant design based on imaging, but it does not mention or imply the use of AI or ML algorithms for this process. The focus is on geometric and anatomical requirements and proprietary/off-the-shelf software, not learning or predictive capabilities.
Yes
The device is a knee replacement system intended to treat painful joint disease and restore joint function, which are therapeutic purposes.
No
This device is a patient-specific knee replacement system designed to treat joint pain and disability, not to diagnose a condition. While it uses imaging for design, that's for manufacturing the implant, not for diagnostic purposes.
No
The device description clearly states that the iTotal CR Knee Replacement System includes physical components such as a femoral component (CoCrMo alloy), a tibial component (metal tray and polyethylene inserts), and a patellar component (UHMWPE). 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:
- 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 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 biological samples.
- Image Processing: While the device uses imaging (CT or MR scans) to design a patient-specific implant, this is for surgical planning and device manufacturing, not for diagnosing a condition from a biological sample.
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, patello-femoral or bi-compartmental prosthesis. The indications for use include :
- t 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.
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR
The iTotal CR KRS is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG
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. 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 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 two polyethylene inserts manufactured from UHMWPE. 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 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 510k i.e. K094050, K103117 and K112780.
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)
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 tray/insert interlock assembly/disassembly 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
1|5
| K120316 | #/5 APR 19 2012 |
|---|---|
| 510(K) SUMMARY | 4/13/12 |
| Submitter's Name | |
| and Address | ConforMIS Inc. |
| 11 North Ave. | |
| Burlington, MA 01803 | |
| Establishment | |
| Registration Number | 3004153240 |
| Date of Summary | January 30, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance & Regulatory |
| 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 | |
| Regulation Number | |
| Device Classification | 21 CFR 888.3560 |
| 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. |
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
ConforMIS iTotal CR Knee Replacement System
4/13/12
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, patello-femoral or bi-compartmental prosthesis. The indications for use include :
- t 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.
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR
The iTotal CR KRS is intended for cemented use only.
ldentification of the Legally Marketed Device (Predicate Device)
KRS) Device Class: III Product Code: JWH, OOG Regulation Number: 21 CFR 888.3560 510(k) number: K103117,K094050 and K112780
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. 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 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 two polyethylene inserts manufactured
2
ConforMIS iTotal CR Knee Replacement System
4/13/12
from UHMWPE. 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 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 510k i.e. K094050, K103117 and K112780.
The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 cleared September16, 2010, K103117 cleared January 7, 2011 and K112780 cleared December15, 2011) and other currently marketed, cemented total knee replacement systems. The following testing was performed to establish substantial equivalence:
Tibial interlock assembly and disassembly testing -
- Design validation via cadaveric testing
Substantial Equivalence:
3
K120316#4/5
K120316
ConforMIS iTotal CR Knee Replacement System
4/13/12
510(k) Summary continued
Device Comparison
| | Predicate
iTotal CR Knee Replacement
System
(K103117) | 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 All Polymer Patellar Component:
UHMWPE | Femoral Implant: CoCrMo Metal Backed Tibial Components: Tibial tray: CoCrMo Tibial Inserts: UHMWPE All Polymer Patellar Component:
UHMWPE |
| 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 Tray undercut design | Interference fit Anterior lip Double Undercut with Central Spine |
| Minimum
Thickness of
Tibial Insert
(UHMWPE) | 6 mm | 6 mm |
| Posterior Cruciate
Ligament (PCL)
Sparing | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
4
K1203/6 #5/5
ConforMIS iTotal CR Knee Replacement System
4/13/12
510(k) Summary continued
Description and Nonclinical Testing: The determination of substantial equivalence Conclusion of for this device was based on a detailed device description. The Testing 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 tray/insert interlock assembly/disassembly testing . Cadaveric testing . Safety and The determination of substantial equivalence for this device was Performance 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, K094050 cleared September 16, 2010, K103117 cleared January 7, 2011 and K112780 cleared December15, 2011.
5
Image /page/5/Picture/0 description: The image shows a partial view of a logo and some text. The logo is a circular emblem with a stylized image of an eagle or similar bird, surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the logo, the word "DEPART" is visible, suggesting that the image is part of a larger document or graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS, Incorporated % Ms. Amita S. Shah 11 North Avenue Burlington, Massachusetts 01803
APR 1.9 2012
Re: K120316
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 Dated: January 30, 2012 Received: February 01, 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 or uny I ederal 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
6
Page 2 - Ms. Amita S. Shah
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,
urs,
Ka
elkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K120316
Device Name: iTotal CR Knee Replacement System
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, patello-femoral 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oveal
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Special 510(k) - Modified iTotal® CR Knee Replacement System Page 24 of 86