(85 days)
Not Found
Unknown
The description mentions "proprietary software" used for image analysis to personalize the implant design, but it does not explicitly state whether this software utilizes AI or ML techniques.
Yes
Explanation: The device is a knee replacement system intended to treat osteoarthritis and traumatic arthritis, which are medical conditions, thereby providing therapy.
No.
The device is a knee replacement system intended to replace a damaged area of the articular surface in the knee. It is a therapeutic device, not a diagnostic one. The mention of image analysis is for personalized implant design, not for diagnosing a condition.
No
The device description clearly states that the system is comprised of physical implants (femoral implant, tibial tray, tibial inserts) made of materials like CoCrMo and UHMWPE. While software is used in the design process, the final device includes hardware components.
No, 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 Description: The provided text describes a surgical implant (a knee replacement system) that is physically placed inside the patient's body.
- Intended Use: The intended use is to replace damaged articular surfaces in the knee due to osteoarthritis or traumatic arthritis. This is a treatment or reconstructive purpose, not a diagnostic one.
- Input: The input is imaging data (MRI or CT scans) used for designing the implant, not biological samples for analysis.
The ConforMIS Unicondylar Knee Replacement System is a medical device, specifically a prosthetic implant, used in a surgical procedure. It does not perform any diagnostic testing on samples taken from the body.
N/A
Intended Use / Indications for Use
The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee repair include those with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee
- previous femoral condyle or tibial plateau fracture, creating loss of function and
- valgus or varus deformity of the knee.
This implant is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
HSX, OOG
Device Description
The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of
- 1 Femoral Implant .
- 1 Tibial Trav o
- 2 or 3 Tibial Inserts 0
The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.
The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.
The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.
The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan.
Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System
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)
The following testing was performed to establish substantial equivalence:
- Femoral Fatigue .
- Femoral Implant fixation
- Cadaveric testing .
- Software validation testing to support changes to the iUni KRS
Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use. Clinical data is 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.
Not Found
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.
K043570, K063432, K072368, K072586, K092441
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
K111916 (1/2)
SEP 2 9 2011
7.0 510(k) SUMMARY
Page 1 of 2
This 510(k) Summary for the ConforMIS® iUni Unicondylar Knee Replacement System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name
and Address: | ConforMIS Inc.
11 North Ave.
Burlington, MA 01804 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amita S. Shah
Vice President, Quality and Regulatory Affairs |
| Date: | July 1, 2011 |
| Name of Medical
Device: | Device Regulation: 21 CFR 888.3520, 21CFR 888.3560
Product Code:
HSX, Knee joint femorotibial metal/polymer non-constrained cemented
prosthesis.
OOG, Knee joint patellofemerotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
Common/Usual Name: Unicondylar Knee Replacement System
Proprietary Name: ConforMIS iUni Unicondylar Knee Replacement
System (iUni KRS)
In accordance with 21 CFR 888.3520, a knee joint femorotibial |
| Device
Classification: | metal/polymer non-constrained cemented prosthesis is classified by the
FDA as a Class II Medical Device. |
| Indications for Use: | The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with
curved tibial insert is intended for use in one compartment of the
osteoarthritic knee to replace the damaged area of the articular surface
in patients with evidence of adequate healthy bone sufficient for support
of the implanted components. |
| | Candidates for unicondylar knee repair include those with:
• joint impairment due to osteoarthritis or traumatic arthritis of the
knee
• previous femoral condyle or tibial plateau fracture, creating loss
of function and
• valgus or varus deformity of the knee. |
| | This implant is intended for cemented use only. |
1
K111916(²/₂)
510(k) SUMMARY Page 2 of 2
Device Description: The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of
- 1 Femoral Implant .
- 1 Tibial Trav o
- 2 or 3 Tibial Inserts 0
The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.
The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.
The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.
The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan.
Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System
Substantial Equivalence:
Safety and
Performance:
The product subject of this premarket notification is substantially equivalent to the currently marketed iUni Unicondylar Knee Repair System (reference K043570, K063432, K072368, K072586 and K092441) and other currently marketed; cemented unicondylar knee replacement systems. The following testing was performed to establish substantial equivalence:
- Femoral Fatigue .
- Femoral Implant fixation �
- Cadaveric testing .
. Software validation testing to support changes to the iUni KRS The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use. Clinical data is not necessary to demonstrate substantial equivalence.
- Software validation testing to support changes to the iUni KR
The determination of substantial equivalence for this device was bas
on a detailed device description. Non-clinical laboratory testing was
performed demonstrating that the device is safe and can be conside
substantially equivalent to the predicate device for the proposed
intended use. Clinical data is not necessary to demonstrate substant
equivalence.
2
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines extending above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is vertically oriented and wraps around the left side of the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Conformis, Inc. % Ms. Amita Shah Vice President, Quality Assurance and Regulatory Affairs l l North Avenue Burlington, Massachusetts 01803
SEP 2 9 2011
Re: K111916
Trade/Device Name: ConforMIS® iUni Unicondylar Knee Replacement 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. OOG Dated: July 1, 2011 Received: July 6, 2011
Dear Ms. Shah:
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 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
3
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric Keith
S/ Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6.0 INDICATION FOR USE STATEMENT
KI11916 510(k) Number (if known):
Device Name: ConforMIS® iUni Unicondylar Knee Replacement System
Indications for Use:
The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee repair include those with:
- o joint impairment due to osteoarthritis or traumatic arthritis of the knee
- � previous femoral condyle or tibial plateau fracture, creating loss of function and
- valgus or varus deformity of the knee. .
This implant is intended for cemented use only.
Prescription Use x (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 ANQTHER PAGE IF NEEDED)
Division Sign Off
Division of C. gical, Orthopedic, Concurrence of CDRH, Office of Device Evaluation (ODE
510(k) Number K111916
Special 510(k) – Modified iUniv Unicondylar G2+ Knee Replacement System