(78 days)
Not Found
No
The summary describes a patient-specific knee implant designed based on CT or MR scans, but it does not mention the use of AI or ML in the design process or any other aspect of the device. The focus is on the patient-specific nature and materials.
Yes
The device is a knee replacement system intended to treat painful joint disease and post traumatic loss of joint function, which are therapeutic indications.
No
The device is a knee replacement system intended for treatment of knee joint pain and disability, not for diagnosis.
No
The device description clearly states that the system consists of physical components (femoral, tibial, and patellar components) made of materials like CoCrMo alloy and UHMWPE, which are implanted into the patient. While it uses patient imaging for design, the final product is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The iTotal CR Knee Replacement System is a physical implant designed to be surgically placed within the knee joint. It does not analyze blood, urine, tissue, or any other bodily fluid or substance in vitro (outside the body).
- The intended use is a surgical implant. The description clearly states it's a "total knee replacement" and an "implant." Its purpose is to replace damaged joint components, not to diagnose a condition based on analyzing biological samples.
- The device description focuses on materials and design for surgical implantation. It discusses metal alloys, polyethylene, and patient-specific design based on imaging, all of which are characteristic of a surgical implant.
The use of imaging (CT or MR scans) is for planning and designing the patient-specific implant, not for performing a diagnostic test on a biological sample.
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 implant 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT or MR scans
Anatomical Site
Knee joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 device for the proposed intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
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ConforMIS iTotal CR Knee Repair System
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JAN - 7 2011
510(K) SUMMARY
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: | October 20, 2010 |
| Name of Medical
Device: | Device Regulation: 21 CFR 888.3560 |
| | Product Code: 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 |
| | In accordance with per 21 CFR 888.3560, a knee joint |
| | patellofemorotibial polymer/metal/polymer non-constrained cemented
prosthesis is classified by the FDA as a Class II Medical Device. |
| 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 implant is intended for cemented use only. |
1
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ConforMIS iTotal CR Knee Repair System
!
VID311
22/06/10
ાવ્
| 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 iTotal Cruciate Retaining Knee Replacement System
(K094050 cleared September 16, 2010) and other currently marketed,
cemented total knee replacement systems. The following testing was
performed to establish substantial equivalence:
Tibiofemoral contact area/contact stress testing Modular assembly and disassembly testing of the tibial tray/insert Constraint testing The proposed iTotal CR KRS has the same technological characteristics
i.e. design, material intended use and function as the predicate iTotal
CR KRS (K094050) as outlined in the table below: |
·
2
ConforMIS iTotal CR Knee Repair System