(123 days)
No
The description focuses on the physical design and materials of the tibial component, which is customized based on patient imaging but does not mention any AI/ML algorithms for analysis or decision-making. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as a component of a knee repair system intended for patients with joint impairment due to osteoarthritis or traumatic arthritis, previous fractures, or deformities, which are conditions that require therapeutic intervention.
No
The device is a component of a knee repair system, specifically a metal-backed tibial component, which is an implant used in surgical procedures to treat joint impairment. Its function is to replace damaged parts of the knee, not to diagnose a condition.
No
The device description explicitly states it consists of a cobalt-chrome alloy tray and a polyethylene insert, which are physical hardware components.
Based on the provided information, 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 Function: The ConforMIS metal backed tibial component is a surgical implant used in knee replacement procedures. It is a physical component that is surgically placed within the patient's body.
- Intended Use: The intended use clearly states it's for treating joint impairment due to conditions like osteoarthritis or fractures, and for use with bone cement during surgery. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details the materials and design of a physical implant, not a diagnostic test kit or instrument.
- Input: While it uses imaging (MRI or CT) for design, this is for customizing the physical implant, not for analyzing biological samples.
Therefore, the ConforMIS metal backed tibial component falls under the category of a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, 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 metal backed tibial component is intended only for use with bone cement
Product codes
HSX
Device Description
The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar | Knee Repair System or the ConforMIS BiCompartmental Knee Repair System to provide the surgeon with an alternative tibial component in the event that he/she prefers to use a metal backed component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT scan
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:
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 further devices. 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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K06 3432
SECTION 2
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 16 2007
1/4
Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc.
323 C Vintage Park Drive
Foster City, CA 94404
Phone 650-286-4151 |
|------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | S. Michael Sharp, PhD
Sr. Vice President, Regulatory/Clinical & Quality |
| Date: | November 10, 2006 |
| Trade/Proprietary Name | Metal Backed Tibial Component ("mBT") |
| Common Name | Metal/polyethylene tibial component |
| Classification Name | 21 CFR 888.3520 - Knee joint femorotibial
metal/polymer non-constrained cemented
prosthesis |
| Device Class | Class II |
| Product Code | HSX |
CONFIDENTIAL
1
K66 3432 2/4
Predicate Devices
| Technological Characteristics | Design | Indications for Use |
|---|---|---|
| ConforMIS UniCondylar | ||
| Knee Repair System | ||
| (K043570) | DePuy Preservation | |
| Unicondylar Knee | ||
| (K040268) | ConforMIS UniCondylar | |
| Knee Repair System | ||
| (K043570) | ||
| ConforMIS | ||
| BiCompartmental | ||
| Knee Repair System | ||
| (K053488) | Link Endo-Model Sled | |
| Uni-Knee | ||
| (K954186) | ConforMIS | |
| BiCompartmental | ||
| Knee Repair System | ||
| (K053488) | ||
| DePuy Preservation | ||
| Unicondylar Knee | ||
| (K040268) | ||
| Link Endo-Model Sled | ||
| Uni-Knee | ||
| (K954186) |
Intended Use:
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, 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 metal backed tibial component is intended only for use with bone cement
Device Description
The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar | Knee Repair System or the ConforMIS BiCompartmental Knee Repair System to provide the surgeon with an alternative tibial component in the event that he/she prefers to use a metal backed component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint") are designed to conform to the patient's anatomy as closely
ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL
November 10 2006
2
K063432 3/4
as possible based on images (MRI or CT scan) of the patient's knee.
Comparison to Predicates
The ConforMIS Metal Backed Tibial Component substantially equivalent to is the tibial components cleared for the ConforMiS Unicondylar and BiCompartmental Knee Repair Systems in the is use of imaging data to design a patient-matched implant geometry, as well terms of design and production process, as well as 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 Unicondylar Knee System found this device to be as safe and effective as the predicate further devices. confirming substantial equivalence.
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 Metal Backed Tibial Component is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS Metal Backed Tibial Component raises no new safety or effectiveness issues.
USE OF THE TERM "SUBSTANTIAL EQUIVALENCE"
The term "Substantial Equivalence" is used in this submission within the confines of the 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.
CONFIDENTIAL
3
4/4 K063432
The present submission and statements therefore should not be construed as affecting or relating to the scope of any 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.
ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL
000003 510(k) Submission November 10, 2006
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is composed of thick, curved lines that give it a modern and abstract appearance. The text is in a simple, sans-serif font.
MAR 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConforMIS, Inc % S. Michael Sharp, PhD Senior Vice President Regulatory and Clinical Affairs 323-C Vintage Park Drive Foster City, California 94404
Re: K063432
Trade/Device Name: Metal Backed Tibial Component 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 12, 2007 Received: February 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.
5
Page 2 - Mr. S. Michael Sharp, PhD
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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Barbara Buchm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number: K 06 24(32
Device Name: ConforMIS Metal Backed Tibial Component (mBT)
Indications for Use:
STATEMENT OF INDICATIONS FOR USE
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, 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 metal backed tibial component is intended only for use with bone cement
Prescription Use ___________________________________________________________________________________________________________(Part 21 CFR 801 Su (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-
CONTINUE ON ANOTHER PAGE IF NEEDED)
Barbara Boccum
(Division Sch-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K063432
000003
ConforMIS, Inc. Metal Backed Tibial Component CONFIDENTIAL
510(k) Submission November 10, 2006