(29 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
The Journey II XR tibial baseplate and inserts were previously cleared for market via premarket notification K141471. Subject of this premarket notification are minor modifications to the insert locking mechanism on the tibial baseplate and insert.
The Journey II XR components are available in medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand and 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.
This document is a 510(k) premarket notification for the "Journey II XR Knee System." It details the submission by Smith & Nephew, Inc. for minor modifications to an existing device.
Here's an analysis of the provided text in response to your questions:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets. Instead, it describes the types of verification testing conducted to demonstrate equivalence to a predicate device. The "reported device performance" is a general statement that the device is equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices with no new safety/effectiveness issues related to: | "A review of the results indicates that the Journey II XR tibial baseplate and inserts are equivalent to the existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices." |
| - Component Interlock Strength of the Tibial Insert Locking Mechanism | (Demonstrated to be equivalent) |
| - Fatigue Strength Testing Of The Tibial Metal Base Tray, Cement And Polyethylene Insert Construct | (Demonstrated to be equivalent) |
| - Tibial Base Fatigue Testing- FEA | (Demonstrated to be equivalent) |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the mechanical verification tests.
The data provenance is not explicitly stated as in country of origin, nor whether it was retrospective or prospective. Given it's mechanical testing for a medical device submission, it would be laboratory-generated data, likely conducted by or for Smith & Nephew.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this document. The "ground truth" here is established through mechanical engineering principles and testing protocols, not by medical experts interpreting data like in a diagnostic study.
4. Adjudication method for the test set
This is not applicable. There's no mention of an adjudication method as would be used in a study involving expert interpretation or consensus. The assessment is based on the results of the mechanical tests themselves.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a knee implant, which is a physical device, not an AI-powered diagnostic tool requiring human reader studies. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical knee implant, not an algorithm or AI system.
7. The type of ground truth used
For this device, the "ground truth" for demonstrating performance is based on mechanical engineering standards and test results, confirming that the modified device's mechanical properties (interlock strength, fatigue strength) are equivalent to those of the predicate device.
8. The sample size for the training set
This is not applicable. There is no training set mentioned or implied for this submission. The evaluation is based on mechanical testing of the physical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Smith & Nephew, Incorporated Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K152726 Trade/Device Name: Journey II XR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 18, 2015 Received: September 22, 2015
Dear Mr. Sheals:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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,
Mark N. Melkerson -S
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) K152726
Device Name Journey II XR Knee System
Indications for Use (Describe)
Total knee components are indicated for theumatoid arthritis, osteoarthritis, 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.
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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| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | September 18, 2015 |
| Contact Person and Address: | Brad ShealsPrincipal Regulatory Affairs SpecialistT 901-399-6897F 901-566-7911 |
| Name of Device: | Smith & Nephew, Inc. Journey II XR |
| Common Name: | Knee Prosthesis |
| Device Classification Name andReference: | 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH |
Device Description
The Journey II XR tibial baseplate and inserts were previously cleared for market via premarket notification K141471. Subject of this premarket notification are minor modifications to the insert locking mechanism on the tibial baseplate and insert.
The Journey II XR components are available in medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand and 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.
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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
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Technological Characteristics
Mechanical testing has been conducted to address the locking mechanism design change. The following verification testing has been conducted:
- Component Interlock Strength of the Tibial Insert Locking Mechanism ●
- Fatigue Strength Testing Of The Tibial Metal Base Tray, Cement And ● Polyethylene Insert Construct - Rationale
- Tibial Base Fatigue Testing- FEA
A review of the results indicates that the Journey II XR tibial baseplate and inserts are equivalent to the existing, legally marketed predicate devices with regards to mechanical performance and 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.
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the Journey II XR knee system cleared via premarket notification K141471. The device subject of this premarket notification is a modification to the aforementioned device.
Table 1: Substantially Equivalent Predicates to the Modified Journey II XR components
| Manufacturer | Description | SubmissionNumber | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | Journey II XR Knee System | K141471 | 11/14/2014 |
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the modified Journey II XR tibial baseplate and inserts. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate knee system.
§ 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.