(104 days)
Not Found
Unknown
The summary mentions "proprietary software" used for image analysis to design patient-specific implants. While this involves complex image processing, the summary does not explicitly state or provide evidence that this software utilizes AI or ML techniques. It could be based on traditional image processing algorithms.
Yes
The ConforMIS Unicondylar Knee Replacement System is intended for use in osteoarthritic knees to replace damaged articular surfaces, which is a therapeutic intervention.
No
This device is a patient-specific unicompartmental knee replacement system, which is a therapeutic implant used for surgical replacement, not for diagnosing conditions.
No
The device description explicitly states that the system is comprised of physical implants (Femoral Implant and Tibial Component made of CoCrMo and UHMWPE) and ancillary instrumentation, in addition to the software used for design.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The ConforMIS Unicondylar Knee Replacement System is a surgical implant designed to replace a damaged part of the knee joint. It is a physical device implanted into the body to restore function.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body in vitro. While it uses imaging data (MRI or CT scans) to design the implant, this is for the purpose of creating a patient-specific physical device, not for providing diagnostic information from a biological sample.
Therefore, the ConforMIS Unicondylar Knee Replacement System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ConforMIS Unicondylar Knee Replacement System (iUni) 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 replacement 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
- valgus or varus deformity of the knee
- revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
Product codes
HSX, OOG
Device Description
ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the 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
Yes
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
Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use: Detailed software description and software verification and validation testing of proprietary software SegSurf. Detailed software description and software verification and validation testing of proprietary software iUniWorks. Detailed software description and software verification and validation testing of proprietary software iUni FemJigs.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(K) SUMMARY (PAGE 1 OF 4) 6.0
| Submitter's Name and Address: | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3009844603 and 3004153240 |
| | DEC 0 5 2013 |
| Date of Summary: | August 21, 2013 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number: | (781) 345-9164 |
| Fax Number: | (781) 345-0104 |
| Name of the Device: | ConforMIS iUni Unicondylar Knee Replacement System (KRS) |
| Common Name: | Unicondylar Knee Replacement System |
| Regulatory Status and Regulation Number: | Class II
21 CFR 888.3520 |
| Classification Name: | HSX - Prosthesis, knee, femorotibial, nonconstrained, cemented, metal/polymerOOG - Knee Arthroplasty Implantation System |
| Indications for Use: | The ConforMIS Unicondylar Knee Replacement System (iUni) 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 replacement include those with: |
| | joint impairment due to osteoarthritis or traumatic arthritis of the kneeprevious femoral condyle or tibial plateau fracture, creating loss of functionvalgus or varus deformity of the kneerevision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans |
| | This implant is intended for cemented use only. |
| Identification of the Legally Marketed Device (Predicate Device): | ConforMIS iUni Unicondylar Knee Replacement System (KRS)
Device Class: II
Product Code: HSX, OOG
Regulation Number: 21 CFR 888.3520
510(k) Number: K121974 and K111916 |
TradItional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0
·
.
-.
1
510(K) SUMMARY (PAGE 2 OF 4)
Device Description: ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the 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 The product subject of this premarket notification is substantially Equivalence: equivalent to the iUni Unicondylar Knee Replacement System (K121974 cleared September 06, 2012 and K111916 cleared September 29, 2011. The following testing was performed to establish substantial equivalence:
Software verification and validation testing of
proprietary software
Traditional 510(k) - Modification of the iUni Knee Replacement System - SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0
.
23
2
K132640 (3/4)
510(K) SUMMARY (PAGE 3 OF 4)
Device Comparison
| Characteristic | Predicate
iUni Unicondylar Knee Replacement System
(K121974 & K111916) | iUni Unicondylar Knee Replacement System
(This submission) |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The ConforMIS Unicondylar Knee
Replacement System (iUni) 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. | The ConforMIS Unicondylar Knee
Replacement System (iUni) 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
replacement 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
• revision procedures provided that
anatomic landmarks necessary for
alignment and positioning of the
implant are identifiable on patient
imaging scans
This implant is intended for cemented use
only. | Candidates for unicondylar knee
replacement 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
• valgus or varus deformity of the knee
• revision procedures provided that
anatomic landmarks necessary for
alignment and positioning of the
implant are identifiable on patient
imaging scans
This implant is intended for cemented use
only. |
| Cement Use Only | Yes | Yes |
| Product
Classification | 21 CFR 888.3520 (HSX) | 21 CFR 888.3520 (HSX) |
| Components and
Materials | • Femoral Implant: CoCrMo
• Metal Backed Tibial Components:
o Tibial tray: CoCrMo
o Tibial Inserts: UHMWPE
• All-Polyethylene Tibial Component:
UHMWPE | • Femoral Implant: CoCrMo
• Metal Backed Tibial Components:
o Tibial tray: CoCrMo
o Tibial Inserts: UHMWPE
• All-Polyethylene Tibial Component:
UHMWPE |
| Design | Prosthesis, knee, femorotibial,
nonconstrained, cemented, metal/polymer | Prosthesis, knee, femorotibial,
nonconstrained, cemented, metal/polymer |
| Patient Matched | Yes | Yes |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Characteristic | Predicate
iUni Unicondylar Knee Replacement System.
(K121974 & K111916) | iUni Unicondylar Knee Replacement System
(This submission) |
| Proprietary
Software for
Segmenting and
Surfacing | SegSurf version 2.0 | SegSurf version 3.0 |
| Proprietary
Software for
Femoral
Components | iUniWorks version 3.0 | iUniWorks version 4.0 |
| Proprietary
Software for the
Femoral Trial | iUni FemJigs version 1.3 | iUni FemJigs version 2.0 |
Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0
3
510(K) SUMMARY (PAGE 4 OF 4)
..
| Description and
Conclusion of
Testing: | Nonclinical Testing: The determination of substantial
equivalence for this device was based on a detailed device
description. The following non-clinical laboratory testing was
performed demonstrating that the device is safe and can be
considered substantially equivalent to the predicate device for
the intended use:
Detailed software description and software verification
and validation testing of proprietary software SegSurfDetailed software description and software verification
and validation testing of proprietary software iUniWorksDetailed software description and software verification
and validation testing of proprietary software iUni
FemJigs |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance: | 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 intended use. Clinical data is not necessary to
demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iUni
Unicondylar Knee Replacement System with the use of SegSurf
v3.0, iUniWorks v4.0, and iUni FemJigs v2.0 production
software modules is substantially equivalent to the iUni
Unicondylar Knee Replacement System (K121974 cleared
September 06, 2012 and K111916 cleared September 29, 2011. |
Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0
.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K132640
Trade/Device Name: ConforMIS" iUni Unicondylar Knee Replacement System (iUni) Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint fomorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II. Product Code: HSX, OOG Dated: September 5, 2013 Received: September 9, 2013
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 10 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. Please note: CDRFI docs not evaluate information related to contract liability warrantics. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
Page 2 - Ms. Amita Shah
device-related adverse events) (21 CFR 803); good manufacturing practive 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/dcfault.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K132640
Device Name:
ConforMIS® iUni Unicondylar Knee Replacement System (iUni)
Indications for Use:
The ConforMIS Unicondylar Knee Replacement System (iUni) 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 replacement 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 .
- valgus or varus deformity of the knee .
- o revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopedic Devices |
Traditional 510(k) - Modification of the iUnl Knee Replacement System - SegSurf v3.0iUniWorks v4.0