(128 days)
Not Found
Unknown
The description mentions "proprietary and off the shelf software" used with patient imaging to design a patient-specific implant. While this process could potentially involve AI/ML for image analysis or design optimization, the summary does not explicitly state the use of these technologies. Without further information, it's impossible to confirm.
Yes
The device is a knee replacement system intended to treat painful joint disease and restore joint function, which are therapeutic purposes.
No
Explanation: The iTotal® CR Knee Replacement System is a patient-specific knee implant designed for joint replacement, not for diagnosing medical conditions. It uses imaging for patient-specific design but its primary function is therapeutic (replacement) rather than diagnostic.
No
The device description clearly states that the system includes physical components such as a femoral component, tibial component (metal tray and polyethylene inserts), and a patellar component, all of which are hardware implants. While software is used for patient-specific design, the core device is a physical implant system.
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 the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The iTotal® CR Knee Replacement System is a surgical implant intended to replace a damaged knee joint. Its purpose is to restore function and alleviate pain in patients with various knee conditions. It is a physical device implanted into the body, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information for diagnosis based on in vitro analysis.
The device utilizes imaging and software for patient-specific design, but this is for the purpose of creating a customized implant for surgical implantation, not for in vitro diagnostic testing.
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, 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
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY, OOG
Device Description
The iTotal Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental 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.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCr) alloy. The tibial component includes a metal tray manufactured from CoCr alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE).
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.
The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate iTotal CR 510(k)s (K131467, K131019 and K122870).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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)
The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. Testing on the femoral components manufactured from an additive manufacturing process is outlined below:
• Material properties tests
• Mechanical properties testing
• Biocompatibility tests
• Contact area/contact stress testing
• Fatigue testing of femoral implant
Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate device for the intended use.
The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices. 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.
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
6.0 510(K) SUMMARY
MAR 2 8 2014
| Submitter's Name
and Address | ConforMIS Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number | 3004153240
3009844603 |
| Date of Summary | November 19, 2013 |
| Contact Person | Amita S. Shah, Senior Vice President, Regulatory and Quality Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0147 |
| Name of the Device | ConforMIS iTotal® Cruciate Retaining Knee Replacement System |
| Common or Usual
Name | Cruciate Retaining Total Knee Replacement System |
| Classification
Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis |
| Regulation Number | 21 CFR 888.3560 |
| Device
Classification | Product Code:
JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented,
Polymer/Metal/Polymer
OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented,
Polymer + Additive/Metal/Polymer +Additive
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. |
| 510(k) Summary
continued | |
| 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 |
| Identification of the
Legally Marketed
Devices
(Predicate Devices) | ConforMIS iTotal CR Knee Replacement System (KRS)
Device Class: II
Product Code: JWH, OOG, OIY
Regulation Number: 21 CFR 888.3560
510(k) number: K131467, K131019, K122870 |
| 510(k) Summary
continued | |
| Device Description | The iTotal Cruciate Retaining Knee Replacement System (hereafter
referred to as the "iTotal CR KRS") is a patient specific tricompartmental
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. |
| | Using patient imaging (either CT or MR scans) and a combination of
proprietary and off the shelf software a patient-specific implant is designed
that best meets the geometric and anatomic requirements of the specific
patient. The femoral component is manufactured from cobalt chromium
molybdenum (CoCr) alloy. The tibial component includes a metal tray
manufactured from CoCr alloy and either one or two polyethylene inserts.
The polyethylene inserts may be manufactured from either UHMWPE or a
highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The
patellar component is also manufactured from either UHMWPE or from a |
| | highly cross-linked Vitamin E infused polyethylene (iPoly XE). |
| | For user convenience, and similar to the predicate iTotal CR KRS,
accessory orthopedic manual surgical instruments designed for use with
the modified iTotal CR KRS are provided to assist with implantation. The
ancillary instruments are provided sterile and for single-use only. These
patient specific instruments are provided to assist in the positioning of total
knee replacement components intra-operatively and in guiding the cutting
of bone. |
| | The function and general design features of the patient specific ancillary
instruments remain similar to those described in the predicate iTotal CR
510(k)s (K131467, K131019 and K122870). |
| 510(k) Summary
continued | |
| Substantial
Equivalence | The product subject of this premarket notification is substantially equivalent
in design and functionality to the iTotal Cruciate Retaining Knee
Replacement System (K131467 cleared July 18, 2013, K131019 cleared
May 24, 2013, and K122870 cleared January 14, 2013). The proposed
femoral components will be manufactured by an additive manufacturing
process using CoCr alloy in a powdered form.
The following non-clinical laboratory testing was performed to determine
substantial equivalence:
Material properties of CoCr implants manufactured by an additive
manufacturing process Mechanical properties testing Physical properties testing Biocompatibility Testing of implants manufactured by the additive
manufacturing process Performance testing of femoral implants manufactured through the
additive manufacturing process Fatigue testing Contact stress/area testing All testing has demonstrated the device is substantially equivalent to the
predicate devices. |
1
2
.
3
.
4
510(k) Summary continued: Device Comparison
| Characteristic | iTotal CR KRS with femoral component
manufactured via an additive manufacturing
process (This submission) | Predicate iTotal CR KRS (K131467, K131019
and K122870) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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 | 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 bi-compartmental
implants. Revision procedures provided that
anatomic landmarks necessary for
alignment and positioning of the
implant are identifiable on patient
imaging scans |
| | The implant is intended for cemented use only | The implant is intended for cemented use only |
| Intended for
Cemented Use Only | Yes | Yes |
| Product
Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) |
| Design | Knee joint patellofemorotibial semi -constrained
cemented prosthesis | Knee joint patellofemorotibial semi -constrained
cemented prosthesis |
| Tibial Implant | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin E
infused highly cross-linked UHMWPE Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin E
infused highly cross-linked UHMWPE Single or Dual inserts Insert sizes: 6-16mm Profile: patient specific |
| Femoral Implant | CoCr - cast, wrought or additive manufacturing process Patient specific | CoCr - cast or wrought material Patient specific |
| Patella Implant | UHMWPE or Vitamin E infused highly cross-linked UHMWPE | UHMWPE or Vitamin E infused highly cross-linked UHMWPE |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| Principle of Operation | Cemented use
Fixed Bearing Design | Cemented use
Fixed Bearing Design |
| Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| Packaging | Device components are individually double
pouched using Tyvek® /film pouches which are
sealed and labeled | Device components are individually double
pouched using Tyvek® /film pouches which are
sealed and labeled |
| Sterility Method/
Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 |
| Initial Shelf-Life | 6 months | 6 months |
| Labeled Non-pyrogenic | No | No |
5
6
・
| 510(k) Summary
| continued | |
|---|---|
| Description and | |
| Conclusion of | |
| Testing | The determination of substantial equivalence for this device was based |
| on a detailed device description and non-clinical laboratory testing. | |
| Testing on the femoral components manufactured from an additive | |
| manufacturing process is outlined below: | |
| • Material properties tests | |
| • Mechanical properties testing | |
| • Biocompatibility tests | |
| • Contact area/contact stress testing | |
| • Fatigue testing of femoral implant | |
| Test results demonstrated that the device is safe and can be considered | |
| substantially equivalent to the predicate device for the intended use. | |
| Safety and | |
| Performance | The determination of substantial equivalence for this device was based |
| on a detailed device description and non-clinical laboratory testing. The | |
| testing demonstrated that the device is safe for its intended use and can | |
| be considered substantially equivalent to the predicate devices. Clinical | |
| data is not necessary to demonstrate substantial equivalence. | |
| Conclusion | Based on the testing conducted, it is concluded that the iTotal Cruciate |
| Retaining Knee Replacement System with femoral components made | |
| from an additive manufacturing process is substantially equivalent to the | |
| iTotal Cruciate Retaining Knee Replacement System (K131467, | |
| K131019 and K122870) |
7
Image /page/7/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is black and the background is white.
March 28, 2014
ConforMIS, Incorporated Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts, USA
Re: K133560
Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG Dated: March 3, 2014 Received: March 4, 2014
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 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
8
Page 2 - Ms. Amita Shah
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/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,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): _K133560
Device Name: iTotal 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 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 |
|---|---|
| (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
| Casey L. Hanley, Ph.D |
|---|
| Division of Orthopedic Devices |
Traditional 510(k) - Modified iTotal® CR KRS - Additive manufacturing