(164 days)
Not Found
No
The document describes a mechanical knee implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
The device is a total knee replacement system, which replaces a damaged joint and does not actively treat or cure a disease or condition in a therapeutic manner.
No
The device is a total knee replacement system, which is a therapeutic device implanted during surgery, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components made of materials like polyethylene and titanium alloy, indicating it is a hardware device. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a total knee replacement system, which is an implantable device used to replace damaged knee joints. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for treating various forms of arthritis and failed previous knee surgeries, which are clinical conditions, not for diagnosing them through laboratory tests.
The description focuses on the physical components of the implant and mechanical testing, which are characteristic of orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:
- . Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
- o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
A review of the mechanical data indicates that the Journey II XR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II XR Knee system was performed:
- Tibiofemoral Contact Area Analysis
- Tibiofemoral Constraint Testing
- Construct Fatigue Strength Testing ●
- Static testing of the insert locking mechanism
- Tibial base plate fatigue performance ●
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices
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.
K904448, K121443, K951987, K041825
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping faces creating a sense of depth and dimension. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Smith and Nephew, Incorporated Ms. Shereen Bienz Senior Regulatory Affairs Specialist 7135 Goodlet Farm Parkway Cordova, Tennessee 38018
Re: K141471 Trade/Device Name: Journey II XR Knee 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 Dated: October 16, 2014 Received: October 17, 2014
Dear Ms. Bienz:
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
1
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/Resourcesfor You/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
2
Premarket Notification Indications for Use Statement
510(k) Number (if known): K141471
Device Name: Journey II XR Knee System
Indications for Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1
3
Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew" in gray and orange. The words "We are" are in gray, while "smith&nephew" is in orange.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | November 12, 2014 |
| Contact Person and Address: | Shereen Bienz
Senior Regulatory Affairs Specialist
T (901) 399-6325
F (901) 566-7075 |
| Name of Device: | Smith & Nephew, Inc. Journey II XR Knee System |
| Common Name: | Knee Prosthesis |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH |
Device Description
Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:
- . Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
- o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.
Technological Characteristics
A review of the mechanical data indicates that the Journey II XR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II XR Knee system was performed:
- Tibiofemoral Contact Area Analysis
- Tibiofemoral Constraint Testing
- Construct Fatigue Strength Testing ●
- Static testing of the insert locking mechanism
- Tibial base plate fatigue performance ●
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices
4
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
Substantial Equivalence Information
The substantial equivalence of the Journey II XR Knee system is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed in the following table.
| Design Aspect
Reviewed | Journey II XR
Knee System | Townley Total
Knee (BioPro) | Journey II CR | Genesis II CR | Genesis II High
Flex Inserts |
|-------------------------------------|------------------------------|--------------------------------|-------------------------|-------------------------|---------------------------------|
| 510(k) Number | Subject 510(k) | K904448 | K121443 | K951987 | K041825 |
| Manufacturer | Smith &
Nephew, Inc. | BioPro, Inc | Smith &
Nephew, Inc. | Smith &
Nephew, Inc. | Smith &
Nephew, Inc. |
| Similar
Indications for
Use | Yes | Yes | Yes | Yes | Yes |
| Similar
Sterilization
Methods | Yes | Yes | Yes | Yes | Yes |
| Bi-cruciate
retaining | Yes | Yes | No | No | No |
| Insert material | XLPE | UHMWPE | XLPE and
UHMWPE | UHMWPE | UHMWPE |
| Similar
Locking
Mechanism | Yes | Yes | Yes | Yes | Yes |
| Tibial base
material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Similar
Manufacturing
Process | Yes | Unknown | Yes | Yes | Yes |
Table 1: Comparison to Substantially Equivalent Devices
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Journey II XR Knee System. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.