(28 days)
Unknown
The summary 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 that AI/ML is used. 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 interventions.
No
This device is a total knee replacement system, which is a prosthetic device used for treatment, not for diagnosing conditions.
No
The device is a knee replacement system which includes physical implants made of metal and polyethylene, as well as surgical instruments. While software is used in the design process, the device itself is not solely software.
Based on the provided text, 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: The iTotal CR Knee Replacement System is a surgical implant intended to replace a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat knee joint pain and disability through surgical replacement, not to diagnose a condition using a sample from the body.
- No Mention of Samples: The description does not mention the analysis of any biological samples. The "patient imaging" is used for designing the implant, not for diagnostic testing of a sample.
Therefore, the iTotal CR Knee Replacement System falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JWH, OOG, OIY
Device Description
The iTotal® CR 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 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 (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly XE™ (a highly cross-linked vitamin E infused polyethylene) The patellar component is also manufactured from either UHMWPE or iPoly XE.
For user convenience, and similar to the predicate iTotal CR KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K160025.
Mentions image processing
Using patient imaging 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 following non-clinical testing was performed to establish substantial equivalence:
- Sterilization Validation to confirm a Sterility Assurance Level (SAL) of 1.0x10-6
- Ethylene Oxide (EO) Residual Testing
- Mechanical, Material, and Chemical Property Testing Post- EO Sterilization for iPoly XE
- Non-pyrogenic status for the iTotal CR was determined using the LAL test method with an identified acceptable testing limit of
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2016
ConforMIS, Incorporated Ms. Amita Shah Sr. Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K161366
Trade/Device Name: ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) 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, OOG, OIY Dated: May 13, 2016 Received: May 17, 2016
Dear Ms. Amita 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
1
(21 CFR Part 807); labeling Parts 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161366
Device Name
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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8.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name and
Address: | ConforMIS, Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | May 13, 2016 |
| Contact Person:
Telephone Number:
Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs
(781) 345-9164
(781) 345-0147 |
| Name of the Device: | ConforMIS iTotal® Cruciate Retaining Knee Replacement System
(iTotal CR KRS) |
| Common Name: | Total Knee Replacement System |
| Regulatory Status and
Regulation Number: | Class II
21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis |
| Device Classification: | Product Code:
JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
OOG: Knee Arthroplasty Implantation System.
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.
OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,
polymer + additive/metal/polymer + additive.
This generic type of device includes prosthesis that have a femoral
component made of alloys, such as cobalt-chromium-molybdenum, and
a tibial component(s) and/or a retropatellar resurfacing component
made of ultra-high molecular weight polyethylene plus an additive, such
as α-tocopherol. |
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510(K) SUMMARY (PAGE 2 OF 5)
| 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.
ldentification of the Legally Marketed Device (Predicate Device):
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: ll Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K160025 & K122870
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510(K) SUMMARY (PAGE 3 OF 5)
Device Description: The iTotal® CR 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 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 (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly XE™ (a highly cross-linked vitamin E infused polyethylene) The patellar component is also manufactured from either UHMWPE or iPoly XE.
For user convenience, and similar to the predicate iTotal CR KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K160025.
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510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The proposed iTotal CR KRS and predicate iTotal CR KRS have the same technological characteristics. There have been no changes to the proposed iTotal CR KRS devices with respect to design, materials, and methods of manufacture, or packaging. The designs of the devices remain similar to those cleared via K160025.
This submission proposes the addition of ethylene oxide sterilization as an alternative sterilization method for the iPoly XE components. The iPoly XE components of the iTotal CR KRS are cleared for sterilization via VHP (Gas Plasma) (K122870). EO Sterilization was cleared as an alternative method of sterilization for the iTotal CR KRS (K133256).
Table 8.0-1: Comparison Between the Proposed and Predicate Implant Components
| Component
Material | Predicate iTotal CR
KRS
(K160025) | Proposed iTotal CR
KRS
(This submission) |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| CrCoMo Femoral and
Tibial Implant | Sterilized via VHP (Gas
Plasma) or Ethylene Oxide
to an SAL of $1.0x10^{-6}$ | Sterilized via VHP (Gas
Plasma) or Ethylene Oxide
to an SAL of $1.0x10^{-6}$ |
| UHMWPE Tibial
Inserts and Patella | Sterilized via VHP (Gas
Plasma) or Ethylene Oxide
to an SAL of $1.0x10^{-6}$ | Sterilized via VHP (Gas
Plasma) or Ethylene Oxide
to an SAL of $1.0x10^{-6}$ |
| iPoly XE (Vitamin E
infused highly cross-
linked UHMWPE) Tibial
Inserts and Patella | Sterilized via VHP (Gas
Plasma) to an SAL of
$1.0x10^{-6}$ | Sterilized via VHP (Gas
Plasma) or Ethylene Oxide
to an SAL of $1.0x10^{-6}$ |
Substantial Equivalence:
The proposed iTotal CR KRS is substantially equivalent to the predicate iTotal CR KRS (K160025 cleared March 7, 2016 and K122870 cleared January 14, 2013). The following non-clinical testing was performed to establish substantial equivalence:
- Sterilization Validation to confirm a Sterility Assurance Level . (SAL) of 1.0x10-6
- Ethylene Oxide (EO) Residual Testing ●
- Mechanical, Material, and Chemical Property Testing Post-. EO Sterilization for iPoly XE
- . Non-pyrogenic status for the iTotal CR was determined using the LAL test method with an identified acceptable testing limit of