(89 days)
Not Found
No
The summary describes patient-specific implant design based on CT scans using proprietary and off-the-shelf software, but does not mention AI or ML. The focus is on patient-specific design and manufacturing, not on automated interpretation or decision-making using AI/ML.
Yes
The device is a knee replacement system intended to treat painful joint diseases and post-traumatic loss of joint function, which are conditions that alleviate symptoms and improve function, classifying it as a therapeutic device.
No
Explanation: The provided text describes the iTotal PS Knee Replacement System, which is an implantable medical device used to replace a damaged knee joint. Its purpose is to treat pain and disability, not to diagnose a condition.
No
The device description clearly states that the system includes physical components (femoral, tibial, and patellar components made of CoCrMo alloy and UHMWPE) and ancillary surgical instruments. While software is used in the design process, the device itself is a physical implant system.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The iTotal PS 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.
- Input: While it uses a CT scan for design, the input is imaging data of the anatomical structure, not a biological sample for diagnostic testing.
Therefore, the iTotal PS Knee Replacement System falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iTotal PS 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, polyarthritis or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- 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, OOG, OIY
Device Description
The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.
The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.
Using patient imaging (CT scan) 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is 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), ancillary orthopedic manual surgical instruments designed for use with the iTotal PS 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 intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K131467 & K131019. There are only a few differences such as the addition of jigs to guide the bone cutting for the femoral box, the introduction of a full thickness flexion spacer to help assess joint space, and the insert trials that are made to match the tibial insert with the spine feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 this device was based on a detailed device description and non-clinical laboratory testing. Testing on the iTotal PS Knee Replacement System included functional testing in compliance with The FDA Guidance Class II Special Controls Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003.
Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:
Femoral Component Fatigue Testing
Tibial Tray Fatigue Testing
Tibial Insert Spine-Femoral Cam Fatigue Testing
Tibiofemoral Contact Area and Surface Stress Testing
Patellofemoral Contact Area and Surface Stress Testing
Patellofemoral Lateral Stability Testing
Tibiofemoral Constraint Analysis
Rotational Laxity Testing
Range of Motion Analysis
Tibial Interlock Strength Testing
Tibial Insert Push-in/Push-out Testing
Cadaveric Evaluation
Software verification and validation testing
MR Compatibility Testing
Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate devices for the intended use.
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, K111433, K113369
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 (PAGE 1 OF 5)
JUN 3 0 2014
| Submitter's Name and
Address: | ConforMIS, Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | March 31, 2014 |
| 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 ® Posterior Stabilized Knee Replacement System
(iTotal PS KRS) |
| Common Name: | Posterior Stabilized 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 a-tocopherol. |
1
510(K) SUMMARY (PAGE 2 OF 5)
Indications for Use:
The iTotal PS 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, polyarthritis or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity. �
- 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.
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: ============================================================================================================================================================================== Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K131467 & K131019
DePuy Attune Knee System Device Class: == Product Code: JWH, OIY Regulation Number: 21 CFR 888.3560 510(k) number: K111433
Zimmer Persona Personalized Knee System Device Class: ll Product Code: JWH Regulation Number: 21 CFR 888.3560 510(k) number: K113369
Identification of the Legally Marketed Device (Predicate Device):
2
510(K) SUMMARY (PAGE 3 OF 5)
Device Description:
The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.
The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.
Using patient imaging (CT scan) 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is 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), ancillary orthopedic manual surgical instruments designed for use with the iTotal PS 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 intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K131467 & K131019. There are only a few differences such as the addition of jigs to guide the bone cutting for the femoral box, the introduction of a full thickness flexion spacer to help assess joint space, and the insert trials that are made to match the tibial insert with the spine feature.
3
510(K) SUMMARY (PAGE 4 OF 5)
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); the DePuy Attune PS Total Knee System (K111433, cleared August 30, 2011); and the Zimmer Persona PS Personalized Knee System (K113369, cleared March 27, 2012).
Functional testing was conducted in compliance with the FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003.
Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:
- Femoral Component Fatigue Testing .
- . Tibial Tray Fatigue Testing
- Tibial Insert Spine-Femoral Cam Fatigue Testing .
- Tibiofemoral Contact Area and Surface Stress Testing .
- Patellofemoral Contact Area and Surface Stress Testing .
- Patellofemoral Lateral Stability Testing .
- Tibiofemoral Constraint Analysis .
- Rotational Laxity Testing .
- Range of Motion Analysis t
- Tibial Interlock Strength Testing .
- . Tibial Insert Push-in/ Push-out Testing
- Cadaveric Evaluation .
- Software verification and validation testing .
- . MR Compatibility Testing
All testing has demonstrated that the device is substantially equivalent to the predicate devices.
4
.
.
·
.
· ·
| Description and
Conclusion of Testing: | Nonclinical Testing: The determination of substantial equivalence for this
device was based on a detailed device description and non-clinical
laboratory testing. Testing on the iTotal PS Knee Replacement System
included functional testing in compliance with The FDA Guidance Class II
Special Controls Class II Special Controls Guidance Document: Knee Joint
Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated
Uncemented Prostheses; Guidance for Industry and FDA, issued January
16, 2003.
Specifically, the following non-clinical laboratory tests were performed to
determine substantial equivalence:
Femoral Component Fatigue Testing Tibial Tray Fatigue Testing Tibial Insert Spine-Femoral Cam Fatigue Testing Tibiofemoral Contact Area and Surface Stress Testing Patellofemoral Contact Area and Surface Stress Testing Patellofemoral Lateral Stability Testing Tibiofemoral Constraint Analysis Rotational Laxity Testing Range of Motion Analysis Tibial Interlock Strength Testing Tibial Insert Push-in/Push-out Testing Cadaveric Evaluation Software verification and validation testing MR Compatibility Testing Test results demonstrated that the device is safe and can be considered
substantially equivalent to the predicate devices 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 Posterior
Stabilized Knee Replacement System is substantially equivalent to the
predicate devices: the iTotal Cruciate Retaining Knee Replacement
System (K131467, cleared July 18, 2013, & K131019, cleared May 24,
2013); the DePuy Attune PS Total Knee System (K111433, cleared August
30, 2011); and the Zimmer Persona PS Personalized Knee System
(K113369, cleared March 27, 2012). |
:
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 0903 New Hamnshire Avenue Document Control Control Conter - WC66-G609 Silver Spring, MI) 20993-0002
June 30, 2014
ConforMIS. Incorporated Ms. Amita Shah Senior Vice-President, Regulatory & Quality Affairs 28 Crosby Drive Bedford. Massachusetts 01730
Re: K140833
Trade/Device Name: ConforM1S iTotal* Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS) 、 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OOG. OIY Dated: March 31, 2014 Received: April 2, 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. Ilisting 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
6
Page 2 - Ms. Amita Shah
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 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" (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. T
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.
ﻨﺘﻬﺎ
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
7
K140833
Indications for Use
K140833 510(k) Number (if known): _
Device Name:
ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (ITotal PS KRS)
Indications for Use:
The iTotal PS 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, theumatoid arthritis, polyarthritis . or osteonecrosis of the knee.
- . Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity. .
- 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 Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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) - iTotal PS KRS