(56 days)
K 043570
K053488, K0526876
No
The description focuses on custom device design based on patient imaging (CT/MR) and manufacturing, without mentioning AI/ML for image analysis, design optimization, or any other function. The performance study compares designs based on different imaging modalities, not AI/ML performance.
Yes.
The device is intended to treat joint impairment due to osteoarthritis or traumatic arthritis of the knee, which are medical conditions, and it replaces a part of the knee condyles, implying a therapeutic intervention to restore function and alleviate symptoms.
No
The device is a knee replacement system that uses patient-specific imaging data for manufacturing. It is a treatment device, not one that diagnoses conditions.
No
The device description clearly states it is a "device developed from patient CT scans or MR images to replace one compartment of the knee condyles," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The ConforMIS Unicondylar Knee System is a surgical implant designed to replace a part of the knee joint. It is implanted into the body, not used to test samples from the body.
- The intended use is for treating joint impairment and deformities. This is a therapeutic purpose, not a diagnostic one.
- The device description focuses on the physical characteristics and function of the implant. It doesn't describe any components or processes for analyzing biological samples.
The information provided clearly describes a medical device used for surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ConforMIS Unicondylar Knee System is intended for use in patients with:
- joint impairment due to osteoarthritis or . traumatic arthritis of the knee
- . Previous tibial condyle or plateau fracture, creating loss of function
- valgus or varus deformity of the knee .
The ConforMIS Unicondylar Knee System is intended for use with cement.
The ConforMIS unicondylar implant is intended for use in patients with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous tibial condyle or plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
The ConforMIS unicondylar implant is for use with bone cement
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
The ConforMIS Unicondylar Knee System ("iUni") is a device developed from patient CT scans or MR images to replace one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and allows internal/external rotation between the femoral and tibial components. Movement is limited by the ligaments and other soft tissues surrounding the device. The device is designed to match the patient's unique normal anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or MR images
Anatomical Site
knee
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: The design verification procedure for the ConforMIS Unicondylar Knee System ("iUni") found that implants designed using MRI data to have the same physical parameters as those for the same patient designed from CT scan data. As all implants are made of the same materials, using identical manufacturing methods, it was concluded that implants designed from MR images would be aas safe and effective as the predicate device, the previously cleared version of the implant designed based on CT scan data.
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): 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.
K 043570
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.
K053488, K0526876
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K 072586 # '1/3
Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc.
2 Fourth Avenue
Burlington, MA 01803 | NOV 0 8 2007 |
|-------------------------------|------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | S. Michael Sharp, PhD
Sr. VP, Regulatory and Clinical Affairs | |
| Phone | 781.860.5111 | |
| FAX | 781.860.5108 | |
| Date: | September 14, 2007 | |
| Trade/Proprietary Name | Unicondylar Knee Repair System/
ConforMIS™ UCD | |
| Common Name | Unicondylar Knee System | |
| Reference/Classification Name | 21 CFR 888.3520 - Knee joint femorotibial
metal/polymer non-constrained cemented prosthesis | |
Predicate Devices:
| Technological Characteristics | Indications for Use |
|---|---|
| • ConforMIS Bicompartmental Knee | |
| (K053488) | |
| • ConforMIS Total Knee (K0526876) | • ConforMIS Unicondylar Knee |
| (K 043570) |
Intended Use:
The ConforMIS Unicondylar Knee System is intended for use in patients with:
- joint impairment due to osteoarthritis or . traumatic arthritis of the knee
- . Previous tibial condyle or plateau fracture, creating loss of function
- valgus or varus deformity of the knee .
The ConforMIS Unicondylar Knee System is intended for use with cement.
1
Use of the Term "Substantial Equivalence"
The term "Substantial Equivalence" is used in this submission within the confines of its statutory use in the FDA's evaluation of a Pre-Market Notification Submission. Any statement regarding Substantial Equivalence used in this submission relates only to whether the device that is the subject of this submission may be lawfully marketed in the United States without pre-market approval or reclassification, and should not be interpreted as an admission, or any kind or type of evidence, in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office.
The present submission and statements therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in the submission, or its use, may be considered indistinct, from a patentability perspective, from any other device referred to in this sub mission.
| Device Description | The ConforMIS Unicondylar Knee System ("iUni")
is a device developed from patient CT scans or MR
images to replace one compartment of the knee
condyles. It is unconstrained in the anteroposterior
and mediolateral directions and allows
internal/external rotation between the femoral and
tibial components. Movement is limited by the
ligaments and other soft tissues surrounding the
device. The device is designed to match the
patient's unique normal anatomy. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicates: | The ConforMIS Unicondylar Knee System ("iUni")
designed from MR images is substantially equivalent
to the ConforMIS Unicondylar Knee System
designed from CT Scan data, in technological
characteristics in terms of design method, design
characteristics and production process, as well as
materials and indications. It is substantially
equivalent to the ConforMIS Bi-Condylar Knee
System and the ConforMIS total knee system in
terms of design method, materials and manufacturing
methods. All are intended for cemented use only. |
| Performance Data | Non-clinical Performance and Conclusions:
The design verification procedure for the ConforMIS
Unicondylar Knee System ("iUni") found that
implants designed using MRI data to have the same
physical parameters as those for the same patient
designed from CT scan data. As all implants are
made of the same materials, using identical
manufacturing methods, it was concluded that |
2
K072586 # 3/3
implants designed from MR images would be aas safe and effective as the predicate device, the previously cleared version of the implant designed based on CT scan data. 1
Clinical Performance:
Clinical data and conclusions are not necessary to demonstrate substantial equivalence
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2007
NOV 0 8 2007
ConforMIS, Inc. % S. Michael Sharp, Ph.D. Sr. Vice President, Regulatory and Clinical 2 Fourth Avenue Burlington, Massachusetts 01803
K072586 Re: Trade/Device Name: ConforMIS Uni-Condylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: September 12, 2007 Received: September 13, 2007
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 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 – S. Michael Sharp, Ph.D.
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 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,
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): K072586
Device Name: ConforMISTM, Inc. Uni-condylar Knee Repair System
Indications for Use:
The ConforMIS unicondylar implant is intended for use in patients with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous tibial condyle or plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
The ConforMIS unicondylar implant is for use with bone cement
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1__ of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K072546
(Posted November 13, 2003)