(77 days)
No
The description focuses on custom device design based on CT scans, not on AI/ML for analysis or decision-making. There are no mentions of AI, ML, DNN, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is a knee replacement system intended to treat joint impairment due to osteoarthritis or traumatic arthritis and previous fractures, which aligns with the definition of a therapeutic device.
No
This device is a knee system intended for use in patients with joint impairment due to osteoarthritis or traumatic arthritis. It is a replacement device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a "device developed from patient CT scans 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The ConforMIS™ Unicondylar Knee System is a surgical implant designed to replace a part of the knee joint. It is physically placed inside the patient's body during surgery.
- Intended Use: The intended use is to treat joint impairment due to conditions like osteoarthritis or traumatic arthritis by replacing damaged parts of the knee. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgically implanted device used for treatment, not a test performed on samples outside the body for diagnostic purposes.
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 for use with cement.
The ConforMIS™ unicondylar implant is intendcd for use in patients with:
- ontoriVIS™ unicondyial implant is incentration anthritis of the knee
- joint impairment due to osteourings of cacture, creating loss of function .
- valgus or varus deformity of the knee e
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 is a device developed from patient CT scans 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 conform to the patient's anatomy as closely as possible based on the CT scans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
knee condyles
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 Unicondylar Knee System 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): 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
§ 888.3520 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
K04357-0
SECTION 2
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of the 510(k) premarket notification for the ConforMIS, Inc. Unicondylar Knee Repair System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
MAR 1 4 2005
CONFIDENTIAL
1
Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc.
323 C Vintage Park Drive
Foster City, CA 94404
Phone 650-286-4151 |
|---------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone
FAX | Lyndall Erb, PhD
Director, Regulatory/Clinical & Quality Assurance
650-286-4166
650-286-4160 |
| Date: | December 22, 2004 |
| Trade/Proprietary Name | Unicondylar Knee Repair System/
ConforMISTM 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 |
|---|---|
| • ConforMIST™ IPD Knee Interpositional | |
| (K033242) | • Zimmer Unicompartmental Knee System |
| (K033363) | |
| • EIUS Unicompartmental Knee System | |
| (K033769) |
The ConforMIS™ Unicondylar Knee System is intended Intended Use: 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 for use with cement.
2
| Device Description | The ConforMIS Unicondylar Knee System is a device
developed from patient CT scans 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 conform to the patient's
anatomy as closely as possible based on the CT scans. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Devices: | The ConforMIS Unicondylar Knee System is
substantially equivalent to the ConforMIS IPD in
technological characteristics in terms of design and
production process, as well as materials and indications.
It is substantially equivalent to the Zimmer
Unicompartmental Knee System and the Repicci II
Unicondylar Knee in that all have similar indications,
design, materials and mechanical safety. 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 Unicondylar Knee System
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. |
·
CONFIDENTIAL
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAR 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lyndall Erb, Ph.D. Director, Regulatory/Clinical Affairs & Quality Assurance ConforMIS., Inc. 323 C Vintage Park Drive Foster City, California 94404
Re: K043570
Trade/Device Name: ConforMIS™ Unicondylar Knee Repair System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 18, 2005 Received: February 22, 2005
Dear Dr. Erb:
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 – Lyndall Erb, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I fills letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification. The I Dri mang of baction for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad rios for your (240) 276-__. Also, please note the regulation entitled, Colliation of Compliance at (210) 210-210-2007 (21CFR Part 807.97). You may obtain Misoranung of Telerence to premainters inibilities under the Act from the Division of Small other general information on Jour respenses Assistance at its toll-free number (800) 638-2041 or jvaliulacturers, International und Constal.http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
O mark X Millican
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K043570
Device Name: ConforMIS™ Unicondylar Knee Repair System
Indications for Use:
The ConforMIS™ unicondylar implant is intendcd for use in patients with:
- ontoriVIS™ unicondyial implant is incentration anthritis of the knee
joint impairment due to osteoarthritis or traver ation loca of function o - joint impairment due to osteourings of cacture, creating loss of function .
- valgus or varus deformity of the knee e
The ConforMIS™ unicondylar implant is for use with bone cement.
Mark n Millican
Vegarotive Division of and Neurological De Carlis
510(k) Number K043570
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
()ver-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
) (PLEASE DO NOT WRITEDED) OF NEEDED)
CONFIDENTIAL