(337 days)
Not Found
No
The description mentions using software for image processing and design based on patient scans, but it does not explicitly state or imply the use of AI or ML algorithms for these processes. The software mentioned appears to be standard design and image processing tools.
Yes
The device is described as a "primary total knee system" intended to restore joint function and relieve pain due to various knee conditions, which are clear therapeutic goals.
No
The device description indicates that the ConforMIS Tri-Compartmental Resurfacing Device is a total knee implant, designed to treat severe pain and disability in the knee due to osteoarthritis or trauma. It is a physical implant designed to be placed in the body, not a device used to diagnose a medical condition. While it uses imaging for custom design, the device itself is a treatment, not a diagnostic tool.
No
The device description clearly states that the device is a "tricompartmental semi-constrained total knee implant" manufactured from metallic alloy and UHMWPE, which are hardware components. While software is used in the design process, the final device is a physical implant.
Based on the provided text, the ConforMIS Tri-compartmental Resurfacing Device (tCR) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The ConforMIS tCR is a surgical implant designed to be placed inside the body to replace damaged knee joint components. Its intended use is to restore joint function and relieve pain due to conditions like osteoarthritis.
- No Specimen Analysis: The description clearly states that the device is designed using patient imaging (MRI or CT scans) and is a physical implant. There is no mention of analyzing biological specimens from the patient.
Therefore, the ConforMIS Tri-compartmental Resurfacing Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use in patients with severe knee joint pain and disability. The indication for use include restoring joint function and relief of pain due to:
- painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid . arthritis of the knee
- . post traumatic loss of joint function
- valgus or varus deformity of the knee .
The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use only with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device is a tricompartmental semi-constrained total knee implant. The design of the product 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 MRI or CT scans) a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The femoral component is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from specific design drawings created from data obtained from images of the patient's individual geometry obtained using either MRI or CT scans. ConforMIS, Inc., implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface design. Subsequently, Solid Works OTS software is used to create the ConforMIS, Inc. Implant Engineering Drawing. The implant is manufactured using multiple SLA and standard casting techniques.
The tibial component is manufactured from UHMWPE (ASTM-F-648) from a drawing produced in a similar manner to the femoral component. It is individualized on its footprint to match the patient's tibial anatomy. The articular surface is designed to be flat in the periphery and slightly concave in the femoral contact area. The all polyethelene (UHMWPE) component is designed for use with bone cement and central cement retention features will be incorporated on the undersurface of the implant. The circumferential size and shape of the tibial component are designed to be 1-3mm within the articulating surface borders of the tibia at the cut bone depth. The minimal polv thickness is 7mm and the component is designed to replace a bone cut of 2-6mm (measured distally from the lowest point of the bony surface of the affected condyle).
The patellar component is also manufactured from UHMWPE.
Mentions image processing
ConforMIS, Inc., implant Software is used to remove surface defects to produce a working design image of a smooth surface.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT 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 device design was evaluated using standardized fatigue, constraint and contact area biomechanical testing. The results of this testing provide objective support for the claim of substantial equivalence.
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.
K033242, K043570, K000978, K974328, K021740
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
510(k) Summary
AUG 3 1 2006
ConforMIS, Inc.
Total Knee Repair System
510(k) Notification K052687
GENERAL INFORMATION
Manufacturer:
ConforMIS, Inc. 323 C Vintage Park Drive Foster City, CA 94404 Phone 650-286-4151 FAX 650-286-4160
Contact Person:
Patrick Hess, PhD Chief Executive Officer ConforMIS, Inc.
Date Prepared:
August 28, 2006 (revised)
DEVICE INFORMATION
Trade/Proprietary Name
Tri-Compartmental Resurfacing (tCR) Device
Common/Classification Name
Knee joint patellofemorotibial cemented prosthesis
21 CFR 888.3560 -- Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.
Class II
Device Product Code: JWH
1
PREDICATE DEVICES
The ConforMIS, Inc. Tri-Compartmental Resurfacing (tCR) Device is substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics. These predicate devices are:
| Technological Characteristics | Indications for Use |
|---|---|
| • ConforMIS Knee Interpositional | |
| Device (K033242) | |
| • ConforMIS Unicompartmental | |
| (K043570) | • Biomet Anatomic Total Knee |
| Prosthesis(K000978) | |
| • Advance® Total Knee system (K974328) | |
| • Alaron Surgical Active Knee® System | |
| (K021740) |
INTENDED USE
The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use in patients with severe knee joint pain and disability. The indication for use include restoring joint function and relief of pain due to:
- painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid . arthritis of the knee
- . post traumatic loss of joint function
- valgus or varus deformity of the knee .
The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use only with bone cement.
PRODUCT DESCRIPTION
The ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device is a tricompartmental semi-constrained total knee implant. The design of the product 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 MRI or CT scans) a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The femoral component is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from specific design drawings created from data obtained from images of the patient's individual geometry obtained using either MRI or CT scans. ConforMIS, Inc., implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface design. Subsequently, Solid Works OTS software is used to create the ConforMIS, Inc. Implant Engineering
2
The implant is manufactured using multiple SLA and standard casting Drawing. techniques.
The tibial component is manufactured from UHMWPE (ASTM-F-648) from a drawing produced in a similar manner to the femoral component. It is individualized on its footprint to match the patient's tibial anatomy. The articular surface is designed to be flat in the periphery and slightly concave in the femoral contact area. The all polyethelene (UHMWPE) component is designed for use with bone cement and central cement retention features will be incorporated on the undersurface of the implant. The circumferential size and shape of the tibial component are designed to be 1-3mm within the articulating surface borders of the tibia at the cut bone depth. The minimal polv thickness is 7mm and the component is designed to replace a bone cut of 2-6mm (measured distally from the lowest point of the bony surface of the affected condyle).
The patellar component is also manufactured from UHMWPE.
SUBSTANTIAL EQUIVALENCE
Technological Characteristics
The technological characteristics of the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device are substantially equivalent to those of the cited predicate orthopedic devices. The image analysis is identical with that used for the ConforMIS interpositional device (iPD) and the ConforMIS unicondylar implant. This device is equivalent in terms of design process, materials, production process, and equipment.
Indications for Use
Substantial equivalence is also supported for the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device by the predicate devices previously cited and cleared in the treatment of osteoarthritic knees where total knee replacement is warranted.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The device design was evaluated using standardized fatigue, constraint and contact area biomechanical testing. The results of this testing provide objective support for the claim of substantial equivalence.
SUMMARY
Based on the similarities in design, materials, function, and intended use, the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS, Inc. Tri-Compartmental Resurfacing (tCR) Device raises no new safety or effectiveness issues.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of four abstract human figures, representing the department's focus on health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2006
Dr. Patrick Hess Chief Executive Officer ConforMIS, Inc. 323 C Vintage Park Drive Foster City, California 94404
Re: K052687
Trade/Device Name: ConforMIS Tri-compartmental Resurfacing Device Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 15, 2006 Received: August 16, 2006
Dear Dr. Hess:
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 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 CFR Part 807); labeling (21 CFR Part 801); 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.
4
Page 2 - Dr. Patrick Hess
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 Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Michum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): #K052687
ConforMIS Tri-compartmental Resurfacing Device Device Name:
Indications for Use:
The ConforMIS Tri-compartmental Resurfacing Device (tCR)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 Tri-compartmental Resurfacing (tCR) Device is intended only for use with bone cement.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
baren (millin) RH, Office of Device Evaluation (ODE) Concurrence (Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number L052687
CONFIDENTIAL