(40 days)
Not Found
No
The description focuses on custom sizing based on imaging, but there is no mention of AI/ML algorithms being used for this process or any other function of the device.
Yes
The device is a total knee replacement system intended to restore joint function and relieve pain due to various knee joint diseases and post-traumatic loss of function, which are therapeutic effects.
No
The device is a knee repair system designed to restore joint function and relieve pain, not to diagnose medical conditions.
No
The device description explicitly states it is a physical component (UHMEPE component) of a total knee repair system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ConforMIS Total Knee Repair System is a surgical implant used to restore joint function and relieve pain in patients with severe knee joint issues. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical component (a tibial component) that is implanted into the patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a patient's health.
- Anatomical Site: The device is used in the knee joint, not to analyze a sample from the knee joint.
- Performance Studies: The performance studies focus on the mechanical safety and effectiveness of the implant itself, not on the accuracy of a diagnostic test.
In summary, the ConforMIS Total Knee Repair System is a medical device used for surgical treatment, not for diagnosing a condition by examining samples outside the body.
N/A
Intended Use / Indications for Use
The ConforMIS Total Knee Repair System ("iTotal") is a minimally invasive, bone preserving primary total knee system intended 'for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid .
- arthritis of the knee .
- Post traumatic loss of joint function .
- Mild to moderate valqus or varus deformity of the knee .
The ConforMIS Total Knee Repair System (iTotal): Tibial Component: is intended only for use with bone cement.
Product codes
JWH
Device Description
The additional 6.0 mm thickness option for the ConforMIS Total Knee Repair System tibial component is intended to provide the surgeon with an additional option for sizing the tibial component. The X/Y dimensions of the component (i.e. the two-dimensional shape or "footprint") are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee. It is available as an UHMEPE component with minimal thickness of 6.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT scan
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)
Non-clinical Performance and Conclusions:
Testing completed as part of the design verification procedure for the ConforMIS Total Knee Repair System Tibial component found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence.
Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence.
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
MAY 12 2008
SECTION 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of the 510(k) pre-market notification for the ConforMIS Total Knee Repair System ("iTotal"): Tibial Component: Extension of Size Range is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc. | |
|---|---|---|
| 2 Fourth Avenue | ||
| Burlington, MA 01803 |
S. Michael Sharp, PhD Contact Person: Sr. Vice President, Regulatory/Clinical & Quality
- March 24, 2008 Date:
- Trade/Proprietary Name ConforMIS Total Knee Repair System (iTotal): Tibial Component Extended Thickness Range
- Knee joint patellofemorotibial Common Name polymer/metal/polymer semi-constrained cemented prosthesis.
Reference/Classification Name: 21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Predicate Devices
| Technological
Characteristics | Design & Insert
Thickness | Indications for Use |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| ConforMIS Total Knee
Repair System
(K052687) | ConforMIS Total Knee
Repair System
(K052687) | ConforMIS Total Knee
Repair System
(K052687) |
| ConforMIS
BiCompartmental
Knee Repair System
(K053488) | ConforMIS
BiCompartmental
Knee Repair System
Polyethylene Tibial Insert
(K072368) | ConforMIS
BiCompartmental
Knee Repair System
(K053488) |
1
Intended Use:
The ConforMIS Total Knee Repair System ("iTotal") is a minimally invasive, bone preserving primary total knee system intended 'for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid .
- arthritis of the knee .
- Post traumatic loss of joint function .
- Mild to moderate valqus or varus deformity of the knee .
The ConforMIS Total Knee Repair System (iTotal): Tibial Component: is intended only for use with bone cement.
Device Description: The additional 6.0 mm thickness option for the ConforMIS Total Knee Repair System tibial component is intended to provide the surgeon with an additional option for sizing the tibial component. The X/Y dimensions of the component (i.e. the two-dimensional shape or "footprint") are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee. It is available as an UHMEPE component with minimal thickness of 6.0 mm.
Comparison to Predicates: The ConforMIS Total Knee Repair System tibial component in the additional size Component is substantially equivalent to the tibial components cleared for use with the ConforMIS uni-compartmental ("iUni") ลทd bi-compartmental ("iDuo") Device in terms of absolute minimum thickness. It is equivalent to the ConforMIS Total Knee Repair System in the use of imaging data to design patient-matched implant geometry; in terms of design and production process; in the use of identical materials and indications. It is substantially equivalent to the cited predicate devices in terms of design, materials, mechanical safety and intended use. All are intended for cemented use only.
Performance Data
Non-clinical Performance and Conclusions:
Testing completed as part of the design verification procedure for the ConforMIS Total Knee Repair System Tibial component found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence.
2
Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence.
SUMMARY
Based on the similarities in design, materials, function and intended use the ConforMIS Total Knee Repair System (iTotal): Tibial Component 6.0mm is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS Total Knee Repair System ("iTotal") 6 mm Tibial Component raises no new safety or effectiveness issues.
3
Public Health Service
Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConforMIS, Inc. % S. Michael Sharp, PhD Senior Vice President Regulatory and Clinical Affairs 2 Fourth Avenue Burlington, Massachusetts 01803
MAY 12 2002
Re: K080936
Trade/Device Name: ConforMIS Total Knee Repair System Tibial Component: 6.0 mm Thickness Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 31, 2008 Received: April 2, 2008
Dear Dr. Sharp:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - S. Michael Sharp, PhD
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): #K0080936- KO80336
Device Name: ConforMIS Total Knee Repair System
Indications for Use:
The ConforMIS Total Knee Repair System ("iTotal") is a minimally invasive, bone preserving primary total knee system intended 'for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to:
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis of the knee
Post traumatic loss of joint function
Mild to moderate valgus or varus deformity of the knee
The ConforMIS Total Knee Repair System ("iTotal") is intended only for use with bone cement.
Prescription Use Over-The-Counter Use x AND/OR (Part 21 CFR 801 Subpart C)
Part 2 (Part 21 CFR 801 Subpart C)
CFUS LEVE CONTRACTURE ON ANOTEL (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R. Ogle - from xm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K080936