(259 days)
Not Found
No
The description focuses on patient-specific design based on imaging and material properties, with no mention of AI/ML for analysis, diagnosis, or treatment planning.
Yes
The device is a knee replacement system intended to treat painful joint disease due to various conditions and post-traumatic loss of joint function, which are therapeutic indications.
No
The device is a knee replacement system used to treat joint pain and disability, not to diagnose a condition.
No
The device description explicitly states it is a "patient specific tri-compartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system" consisting of physical components (femoral, tibial, and patellar) made from materials like CoCrMo alloy and UHMWPE. While it uses patient imaging for design, the device itself is a physical implant.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The iTotal® CR Knee Replacement System is a physical implant designed to replace a damaged knee joint. Its intended use is to treat pain and disability in the knee through surgical implantation.
- Lack of Biological Sample Analysis: The description and intended use do not involve the analysis of any biological samples from the patient. The device is a physical prosthesis.
- Input Imaging Modality: The input is imaging data (CT or MR scans), which is used for designing the patient-specific implant, not for analyzing biological markers.
Therefore, the iTotal® CR Knee Replacement System falls under the category of a medical device (specifically, a surgical implant), not an in vitro diagnostic device.
N/A
Intended Use / 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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal® CR Knee Replacement System is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The proposed iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tri-compartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system.. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a 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 device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is 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 joint
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 laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate devices for the proposed intended use. The following testing was performed on the subject device: Femoral Fatigue Testing, Kinematic Range of Motion Testing, Stability Characteristics Testing, Patello-Femoral Lateral Stability Testing, Contact Area and Surface Stress for the Patello-Femoral Articulation testing, Tibial-Femoral Contact Areas and Stress Testing, Modular Assembly and Disassembly Characteristics of the iTotal Tibial Plateau Testing and UHMWPE Characterization. Clinical data is not necessary to demonstrate substantial equivalence. Results of the bench testing conducted demonstrate that the iTotal KRS is substantially equivalent to the Predicate Knee Systems.
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
§ 888.3560 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
K094050 #1/5
5.0 510(k) SUMMARY
SEP 1 3 2010
This 510(k) Summary for the ConforMIS iTotal® Cruciate Retaining (CR) 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.
2 Fourth Ave.
Burlington, MA 01804 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amita S. Shah, Director, Quality Assurance and Regulatory Affairs |
| Date: | December 29, 2009 |
| Name of Medical Device: | Device Regulation: 21 CFR 888.3560
Product Code: OR (87) JWH, Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis
Common/Usual Name: Cruciate Retaining Total Knee Replacement System
Proprietary Name: ConforMIS iTotal Cruciate Retaining Knee Replacement System |
| Device Classification: | Class II |
| 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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal® CR Knee Replacement System is intended for cemented use only. |
| Device Description: | The proposed iTotal CR Knee Replacement System (hereafter
referred to as the "iTotal CR KRS") is a patient specific tri-
compartmental faceted posterior cruciate ligament (PCL) retaining
knee replacement system.. The iTotal CR KRS is a semi-constrained
cemented knee implant which consists of a femoral, tibial and
patellar component. The product design incorporates a bone
preserving approach with minimal bone resection of the tibia and
femur for the treatment of severe pain and/or disability of a 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 device is manufactured
from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial
component includes a metal tray manufactured from CoCrMo alloy
and either one or two polyethylene inserts manufactured from
UHMWPE of identical configuration. The patellar component is
manufactured from UHMWPE. |
| Substantial Equivalence: | The product subject of this premarket notification is substantially
equivalent to the ConforMIS Tri-Compartmental Resurfacing (tCR)
device (K052687), the Stryker Triathlon CR Total Knee System
(K040267) and the Smith & Nephew Journey Bicruciate Stabilized
Knee System (K042515) all of which are cemented total knee
replacement systems. See Table 5-1 below for a more detailed
comparison. |
1
K094050 #2/5
510(k) SUMMARY
Table 5-1: Comparison of the Proposed iTotal CR KRS and Predicate Knee Systems
| Feature | Proposed Device
iTotal CR Knee
Replacement System | Predicate Device
ConforMIS
Tri-
Compartment
al
Resurfacing
(tCR) device
(K052687) | Predicate Device
Stryker Triathlon
CR Total Knee
System
(K040267) | Predicate Device
Journey Bicruciate
Stabilized Knee System
(K042515) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The iTotal® CR Knee
Replacement System is
intended for use as a total | The ConforMIS
Inc., Tri-
Compartmental | The Triathlon CR Total
Knee System consists of
femoral component, tibial | Total knee components are
indicated for rheumatoid arthritis;
post-traumatic arthritis, |
| 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 bi-compartmental
prosthesis. The indications
for use include:
Painful joint disease
due to osteoarthritis,
traumatic arthritis or
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,
hemiarthoplasties,
unicondylar,
patellofemoral or
bicompartmental
implants. The iTotal® CR Knee
Replacement System is
intended for cemented use
only. | Resurfacing (ICR)
Device is intended
for use in patients
with severe knee
joint pain and
disability. The
indication for use
include:
Painful joint
disease due
to
osteoarthritis
, traumatic
arthritis or
rheumatoid
arthritis of the
knee Post
traumatic loss
of joint
function Valgus or
varus
deformity of
the knee The ConforMIS Tri-
compartmental
Resurfacing (tCR)
device is intended
for use only with
bone cement. | insert, and all
polyethylene patellar
components that are
intended to be used with
previously cleared
Triathlon Primary
Cemented Tibial Tray in
primary or revision total
knee arthroplasty. The
Triathlon All Polyethylene
Patellar components are
intended to be used with
femoral components of
the previously released
Duracon Total Knee
System, as well as the
previously released
Triathlon PS femoral
component in situations
where replacement of the
articular surface of the
patella is required. The
Triathlon CR Total Knee
System is intended to
accommodate the
posterior cruciate ligament
(PCL) if it is present.
Specific indication and
contraindications are
listed below
Indications:
Painful, disabling
joint disease of the
knee resulting from:
non inflammatory
degenerative joint
disease (including
osteoarthritis,
traumatic arthritis or
avascular necrosis)
or rheumatoid
arthritis Post- traumatic loss
of knee joint
configuration and
function Moderate varus,
valgus or flexion
deformity in which
the ligamentous
structures can be
returned to adequate
function and
stability. Revision of previous
unsuccessful knee
replacement or other
procedure | osteoarthritis, or degenerative
arthritis in older patients whose
age, weight, and activity level are
compatible with an adequate long-
term result: failed osteotomies,
unicompartmental replacement, or
total knee replacement. Posterior
stabilized knee systems are
designed for use in patients in
primary and revision surgery,
where the anterior and posterior
cruciate are absent or
incompetent and collateral
ligaments remain intact. Smith &
Nephew, Inc., High Performance
Knee components are indicated
for use only with cement and are
single use devices. | |
| | | | | |
| | | | femur and/or
proximal tibia that
cannot be stabilized
by standard fracture
management
techniques. | |
| Intended for
Cement use only | Yes | Yes | Yes | Yes |
| Components | • Femoral Component
• Tibial Implant
• Metal backed tibial
component
• Patellar component | • Femoral
Component
• Tibial Implant
• All Poly
tibial
component
• Patellar
component | • Femoral Component
• Tibial Implant
• Metal backed
tibial
component
• Patellar component | • Femoral Component
• Tibial Implant
• Metal backed tibial
component
• Patellar component |
| Materials | • Femoral Implant-
CoCrMo
• Metal-Backed Tibial
Components:
• Tibial tray-
CoCrMo
• Tibial Inserts-
UHMWPE
• All Polymer Patellar
Component-
(UHMWPE) | • Femoral
Implant-
CoCrMo
• All poly tibia
component
-UHMWPE
• All Polymer
Patellar
Component-
(UHMWPE | • Femoral Implant-
CoCrMo
• Metal-Backed Tibial
Components:
• Tibial tray* -
CoCrMo
• Tibial Insert-
UHMWPE with
CoCrMo
locking wire
• All Polymer Patellar
Component-
(UHMWPE) | • Femoral Implant- Oxidized
Zirconium
• Metal-Backed Tibial
Components:
• Tibial tray- CoCrMo
• Tibial Insert-UHMWPE
• All Polymer Patellar
Component-(UHMWPE) |
| Design | Knee joint
patellofemorotibial semi -
constrained cemented
prosthesis | Same | Same | Same |
| Principle of
Operation | Cemented Use
fixed Bearing Design | Same | Same | Same |
| Patient-
Specific | Yes | Yes | No | No |
| Patellar
Design/Dimensions | Symmetrical, offered in
sizes ranging from 32, 35,
38 and 41 mm, with
corresponding heights of
6, 7, 8.5 and 10 mm | Offset Dome | Symmetrical or
Asymmetrical, offered in
sizes ranging from 27 to
39 mm in diameter and 8
to 11 mm in thickness. | Symmetrical, offered in sizes
ranging from 26 to 41mm in
diameter and 7 to 9 mm in
thickness |
| Minimum
Thickness of
Tibial Insert
(UHMWPE) | 6 mm | All poly tibial
component -6mm | 6mm | 6mm |
| Posterior
Cruciate
Ligament
(PCL) Sparing | Yes | Yes | Yes | No
Posterior stabilized |
Traditional 510(k) – ConforMIS iTotal CR Knee Replacement System
2
K094050-03/5
Traditional 510(k) – ConforMIS iTotal CR Knee Replacement System
・
36
3
Koryato 4/5
Traditional 510(k) – ConforMIS iTotal CR Knee Replacement System
37
4
K094050 * 5/5
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 devices for the proposed intended use.
The following testing was performed on the subject device: Femoral Fatigue Testing, Kinematic Range of Motion Testing, Stability Characteristics Testing, Patello-Femoral Lateral Stability Testing, Contact Area and Surface Stress for the Patello-Femoral Articulation testing, Tibial-Femoral Contact Areas and Stress Testing, Modular Assembly and Disassembly Characteristics of the iTotal Tibial Plateau Testing and UHMWPE Characterization. Clinical data is not necessary to demonstrate substantial equivalence. Results of the bench testing conducted demonstrate that the iTotal KRS is substantially equivalent to the Predicate Knee Systems.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS, Inc. % Ms. Amita S. Shah 2 Fourth Avenue Burlington, Massachusetts 01803
SEP 1 3 2010
Re: K094050
Trade/Device Name: ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement
System
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis
Regulatory Class: II Product Code: JWH Dated: July 16, 2010 Received: July 19, 2010
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
6
Page 2 - Ms. Amita S. Shah
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 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/Resourcesfor You/Industry/default.htm1.
Sincerely yours,
Mark A. Milkein
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATION FOR USE STATEMENT 4.0
510(k) Number (if known): KO9YOSO
SEP 1 © 2010
Device Name: ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System
Indications for Use:
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 bothe use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental . implants.
The iTotal CR KRS 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutu for mxm
and Restorative Devices
510(k) Number Ko 94050
Traditional 510(k) - ConforMIS iTotal CR Knee Replacement System