(78 days)
Not Found
No
The document describes patient-specific implants designed using patient imaging, but there is no mention of AI or ML being used in the design process or any other aspect of the device or its use.
Yes
The device is a knee replacement system intended for the treatment of severe pain and disability of the knee, which is a therapeutic purpose.
No.
The device descriptions clearly state that these are knee replacement systems (implants) intended for treatment of severe pain and/or disability of the knee. They are used to replace damaged parts of the knee, not to diagnose conditions.
No
The device description explicitly states that the device consists of physical components (femoral, tibial, and/or patellar components made of CoCrMo alloy and UHMWPE) which are implanted into the patient. While software is used in the design process, the final device is a physical implant, not software only.
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 Description and Intended Use: The provided text clearly describes the ConforMIS knee replacement systems as implants intended for surgical use to replace damaged knee joints. They are physical devices inserted into the body.
- Input: The input is patient imaging (CT or MR scans), which is used for designing the patient-specific implant, not for analyzing biological samples.
- Performance Studies: The non-clinical testing described focuses on sterilization validation and compatibility, which are relevant to implantable devices, not IVDs.
Therefore, the ConforMIS knee replacement systems are medical devices, specifically implants, and do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
iTotal
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The indications for use include:
- . Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- . Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- . Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- 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.
iUni
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.
iDuo
The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to :
- . Painful joint disease due to osteoarthritis
- Traumatic arthritis of the knee .
- Post traumatic loss of joint function .
- . Failed osteotomies, hemiarthroplasties and unicondylar implants
The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.
The iDuo implant is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, NPJ, HSX
Device Description
ConforMIS knee replacement systems are patient-specific semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
The femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging (either CT or MR scans)
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)
Nonclinical Testing: The determination of substantial equivalence for these devices was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the devices are safe and can be considered substantially equivalent to the predicate devices for the intended use:
Sterilization Validation testing to establish a SAL of 1x10-6
EO residual testing
Product and packaging compatibility with ethylene oxide sterilization
The determination of substantial equivalence for these devices was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the devices are safe and can be considered substantially equivalent to the predicate devices for the proposed intended use. Clinical data is not necessary to demonstrate substantial equivalence.
Based on the testing conducted it is concluded that the modified devices are substantially equivalent to the predicate devices and can be sterilized to a SAL of 1x10-6 using ethylene oxide sterilization.
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.
K131467, K131019, K121974, K111916, K093513
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JAN - 9 2014
| 6.0 510(K) SUMMARY | |
|---|---|
| Submitter's Name | ConforMIS Inc. |
| 28 Crosby Drive | |
| Bedford, MA 01730 | |
| Establishment | |
| Registration | |
| Number: | 3009844603 and 3004153240 |
| Date of Summary: | October 22, 2013 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and |
| Quality Affairs | |
| Telephone Number: | (781) 345-9164 |
| Fax Number: | (781) 345-0147 |
| Name of the | |
| Device(s): | ConforMIS iTotal CR Knee Replacement System |
| ConforMIS iUni Unicondylar Knee Replacement System | |
| ConforMIS iDuo Bicompartmental Knee Repair System | |
| Common Name(s): | Total Knee Replacement System |
| Unicondylar Knee Replacement System | |
| Bicompartmental Knee Replacement System | |
| Regulatory Status | |
| and Regulation | |
| Number: | Class II |
| 21 CFR 888.3560, 21 CFR 888.3520 | |
| Device | |
| Classification: | Class II |
| Product Codes: | |
| JWH, Knee joint patellofemorotibial | |
| polymer/metal/polymer semi-constrained cemented | |
| prosthesis |
.
11
`,
1
OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
NPJ, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
HSX, Knee joint femorotibial metal/polymer nonconstrained cemented prosthesis
Indications for Use:
iTotal
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The indications for use include:
- . Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- . Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- . Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that . anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
2
This implant is intended for cemented use only.
iUni
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.
iDuo
The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to :
- . Painful joint disease due to osteoarthritis
- Traumatic arthritis of the knee .
- Post traumatic loss of joint function .
- . Failed osteotomies, hemiarthroplasties and unicondylar implants
The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.
The iDuo implant is intended for cemented use only.
3
| Identification of the
Legally Marketed
Device(s) (Predicate
| Device): | |
|---|---|
| ConforMIS iTotal CR Knee Replacement System | |
| Device Class: II | |
| Product Code: JWH, OOG | |
| Regulation Number: 21 CFR 888.3560 | |
| 510(k) Number: K131467 and K131019 | ConforMIS knee replacement systems are patient- |
| specific semi-constrained knee implants which consist of | |
| a femoral, tibial, and/or patellar components. The | |
| products are intended for treatment of severe pain and/or | |
| disability of the knee damaged by osteoarthritis or | |
| trauma. |
Using patient imaging (either CT or MR scans), a patient-
specific implant is designed that best meets the
geometric and anatomic requirements of the specific
patient. The femoral components of the devices are
manufactured from cobalt chromium molybdenum
(CoCrMo) alloy. The tibial component includes a metal
tray manufactured from CoCrMo alloy and polyethylene
inserts manufactured from UHMWPE or an all
polyethylene tibial component. The patellar components
are manufactured from UHMWPE. |
| ConforMIS iUni Unicondylar Knee Replacement System
Device Class: II
Product Code: HSX, OOG
Regulation Number: 21 CFR 888.3520
510(k) Number: K121974 and K111916 | |
| ConforMIS iDuo Bicompartmental Knee Repair System
Device Class: II
Product Code: NPJ, OOG
Regulation Number: 21 CFR 888.3560
510(k) Number: K093513 | |
| Device Description: | |
·
·
4
| Substantial | The products subject to this premarket notification are |
|---|---|
| Equivalence: | substantially equivalent to the predicate devices. |
| The following testing was performed to establish | |
| substantial equivalence: |
- Sterilization Validation to Sterility Assurance . Level (SAL) of 1x10-6 .
- . Ethylene Oxide (EO) Residual Testing
- Product and packaging compatibility with ethylene . oxide sterilization
5
Device Comparison
| | iTotal CR Knee Replacement
System (K131467 and K131019)
iUni Unicondylar Knee Replacement
System (K121974 and K111916)
Duo Bicompartmental Knee Repair
System (K093513 | Replacement System
Duo Bicompartmental Kne |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Femoral Implant: CoCrMo
Tibial Implant
o All Poly Tibial component -
UHMWPE
o Metal Backed Tibial Components:
Tibial tray: CoCrMo
ಂ
Tibial Inserts: UHMWPE
0
Patellar Component: UHMWPE | Same |
| Design &
Principle of
Operation | Knee joint semi-constrained cemented
prosthesis
Cemented Use Fixed Bearing Design | Same |
| ndications for | iTotal
The iTotal CR Knee Replacement System
(KRS) is intended for use as a total knee
replacement in patients with knee joint pain
and disability whose conditions cannot be
solely addressed by the use of a prosthetic
device that treats only one or two of the
three knee compartments, such as a
unicondylar, patellofemoral or
bicompartmental prosthesis.
The Indications for Use include:
• Painful joint disease due to
osteoarthritis, traumatic arthritis,
rheumatoid arthritis or osteonecrosis
of the knee.
Post traumatic loss of joint function.
Moderate varus, valgus or flexion
deformity in which the ligamentous
structures can be returned to
adequate function and stability.
· Failed osteotomies,
hemiarthroplasties, and unicondylar,
patellofemoral or bicompartmental
implants.
Revision procedures provided that | Same |
| Attribute | Predicate Devices | Modified Device
(This submission) |
| | iTotal CR Knee Replacement
System (K131467 and K131019) iUni Unicondylar Knee Replacement
System (K121974 and K111916) iDuo Bicompartmental Knee Repair
System (K093513) | iTotal CR Knee Replacement
System iUni Unicondylar Knee
Replacement System iDuo Bicompartmental Knee
Repair System |
| | anatomic landmarks necessary for
alignment and positioning of the
implant are identifiable on patient
imaging scans.
This implant is intended for cemented use
only.
iUni
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. | Same |
| | iDuo
The ConforMIS iDuo Bicompartmental
Knee Repair System is intended for use in
patients with severe knee joint pain and
disability whose conditions cannot be solely
addressed by the use of a prosthetic device | Same |
| Attribute | Predicate Devices | Modified Device
(This submission) |
| | iTotal CR Knee Replacement
System (K131467 and K131019)
iUni Unicondylar Knee Replacement
System (K121974 and K111916)
iDuo Bicompartmental Knee Repair.
System (K093513)
that treats only a single knee compartment,
such as unicondylar or patellofemoral
prosthesis. The indications for use include
| iTotal CR Knee Replacement
System
iUni Unicondylar Knee
Replacement System
iDuo Bicompartmental Knee
Repair System |
| Patient Matched
implants and
instruments | Yes | Same |
| Instrumentation | Patient specific Nylon jigs | Same |
| Packaging | Device components are double-pouched
using Tyvek®/film pouches which are
sealed and labeled | Same |
| Sterility Method/
Assurance Level | VHP Gas Plasma with SAL of 1x10-6 | VHP Gas Plasma with SAL of 1x10-6
and
Ethylene oxide with SAL of 1x10-6 |
| Initial Shelf-Life | 6 months | Same |
| Labeled Non- | No | Same |
Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization
6
K133256 (7/9)
.
·
·
·
"
Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization
・
7
Traditional 510(k)
ConforMIS – Addition of Ethylene Oxide Sterilization
8
. .
.
| iUni Unicondylar Knee Replace
stem (K121974 and K11191
nin
ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
5 | eblacement
Bicc |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | |
| Description and
Conclusion of
Testing | Nonclinical Testing: The determination of substantial equivalence
for these devices was based on a detailed device description. The
following non-clinical laboratory testing was performed
demonstrating that the devices are safe and can be considered
substantially equivalent to the predicate devices for the intended
use:
Sterilization Validation testing to establish a SAL of 1x10-6 EO residual testing Product and packaging compatibility with ethylene oxide
sterilization |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | The determination of substantial equivalence for these devices was
based on a detailed device description. Non-clinical laboratory
testing was performed demonstrating that the devices are safe and
can be considered substantially equivalent to the predicate devices
for the proposed intended use. Clinical data is not necessary to
demonstrate substantial equivalence. |
| Conclusion | Based on the testing conducted it is concluded that the modified
devices are substantially equivalent to the predicate devices and
can be sterilized to a SAL of 1x10-6 using ethylene oxide
sterilization. |
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
ConforMIS, Incorporated Ms. Amita S. Shah Senior Vice President. Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K133256
Trade/Device Name: ConforMIS® iTotal Cruciate Retaining Knee Replacement System (iTotal CR KRS), ConforMIS® iUni Unicondylar Knee Replacement System, ConforMIS® iDuo Bicompartmental Knee Repair System (iDuo KRS)
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
Regulatory Class: Class II Product Code: JWH. HSX, NPJ, OOG Dated: October 22, 2013 Received: October 23, 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
10
Page 2 - Ms. Amita S. Shah
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, 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.
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" (21 CFR 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.
Sincercly yours.
Ronaldillean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure.
11
iTotal CR Knee Replacement System
510(k) Number (if known): K133256
Device Name: ConforMIS® Total Cruciate Retaining Knee Replacement System (iTotal CR KRS)
Indications for Use:
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include:
- . Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or . bicompartmental implants.
- 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 X
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 1 of 3
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey Li Division
Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterilization
12
iUni Unicondylar Knee Replacement System
510(k) Number (if known): K133256
Device Name: ConforMIS® iUni Unicondylar Knee Replacement 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 knee
AND/OR -
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.
Prescription Use _ X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 2 of 3
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterilization
13
iDuo Bicompartmental Knee Replacement System
510(k) Number (if known): K133256
Device Name: ConforMIS® iDuo Bicompartmental Knee Repair System (iDuo KRS)
Indications for Use:
The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:
- Painful joint disease due to osteoarthritis .
- Traumatic arthritis of the knee. .
- Post traumatic loss of joint function .
- . Failed osteotomies, hemiarthroplasties, and unicondylar implants.
The iDuo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions.
The iDuo 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 ANOTHER PAGE IF NEEDED)
Page 3 of 3
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Traditional 510(k) ConforMIS - Addition of Ethylene Oxide Sterllization