(72 days)
No
The summary describes a mechanical implant with modifications to its physical design and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device, a unicompartmental knee implant, is designed to restore function to a knee affected by various conditions like osteoarthritis and fractures, which directly addresses a health condition.
No
This device is a unicompartmental knee implant, which is a prosthetic device used for surgical implantation to restore a knee joint, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implant (tibial baseplate and inserts made of polyethylene and titanium alloy) and associated instruments, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for restoring a knee joint affected by various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee implant (tibial baseplate and inserts) made of materials like polyethylene and titanium alloy. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies described are mechanical tests related to the structural integrity and function of the implant, not diagnostic accuracy metrics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted into the body to treat a condition.
N/A
Intended Use / Indications for Use
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.
Product codes
HSX
Device Description
The Journey II Uni tibial baseplate and inserts are modifications of the existing Journey Uni tibial baseplate and inserts that were previously cleared for market via K102069 (baseplates) and K061011 (inserts). The subject of this premarket notification are modifications to the insert locking mechanism on the tibial baseplate and insert, articular surface geometry, sizing of baseplate and inserts, and characteristics of the cemented surface of the baseplate. Additional device specific instruments are also included as part of the submission.
The Journey II Uni inserts are available in left medial/right lateral and right medial/left lateral cross-linked polyethylene articular inserts and titanium alloy (Ti-6Al-4V) tibial bases which will be available in left medial/right lateral and right medial/left lateral.
The Journey II Uni tibial baseplate and inserts will use existing Journey Uni femoral components cleared via K081351 or GENESIS Uni femoral components cleared via K912735.
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
Mechanical verification testing/analysis conducted for the subject device includes:
- Unsupported Baseplate Fatigue Testing
- Static testing of the insert locking mechanism including ML/AP Shear Load
- Fully Supported Fatigue/Cement Adhesion Testing
- Contact Area Analysis
A review of the results indicates that the Journey II Uni 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 device(s). Clinical data was not needed to support the safety and effectiveness of the subject device(s).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other, forming a stylized representation of a person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2015
Smith & Nephew, Incorporated Mr. Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K152315 Trade/Device Name: Journey II Uni Tibial Base and Insert Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: October 1, 2015 Received: October 5, 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
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,
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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Premarket Notification Indications for Use Statement
K152315 510(k) Number (if known):
Device Name: Journey II Uni Tibial Base and Insert
Indications for Use:
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic � arthritis, or avascular necrosis;
- o Correction of functional deformity:
- o Revision procedures where other treatments or devices have failed; and
- . Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.
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
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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" in gray, and "smith&nephew" in orange. The text is arranged horizontally, with the flower symbol adding a visual element to the overall design.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 15, 2015 |
| Contact Person and Address: | Brad Sheals
Principal Regulatory Affairs Specialist
T 901-399-6897
F 901-566-7911 |
| Name of Device: | Smith & Nephew, Inc. Journey II Uni Tibial Baseplate
and Insert |
| Common Name: | Knee Prosthesis |
| Device Classification Name and
Reference: | 21 CFR 888.3520 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSX |
Device Description
The Journey II Uni tibial baseplate and inserts are modifications of the existing Journey Uni tibial baseplate and inserts that were previously cleared for market via K102069 (baseplates) and K061011 (inserts). The subject of this premarket notification are modifications to the insert locking mechanism on the tibial baseplate and insert, articular surface geometry, sizing of baseplate and inserts, and characteristics of the cemented surface of the baseplate. Additional device specific instruments are also included as part of the submission.
The Journey II Uni inserts are available in left medial/right lateral and right medial/left lateral cross-linked polyethylene articular inserts and titanium alloy (Ti-6Al-4V) tibial bases which will be available in left medial/right lateral and right medial/left lateral.
The Journey II Uni tibial baseplate and inserts will use existing Journey Uni femoral components cleared via K081351 or GENESIS Uni femoral components cleared via K912735.
4
Intended Use
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic . arthritis, or avascular necrosis;
- . Correction of functional deformity:
- . Revision procedures where other treatments or devices have failed; and
- . Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.
Technological Characteristics
Mechanical verification testing/analysis conducted for the subject device includes:
- Unsupported Baseplate Fatique Testing ●
- . Static testing of the insert locking mechanism including ML/AP Shear Load
- Fully Supported Fatigue/Cement Adhesion Testing ●
- Contact Area Analysis .
A review of the results indicates that the Journey II Uni 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 device(s). Clinical data was not needed to support the safety and effectiveness of the subject device(s).
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and very similar in overall design to the Journey Uni knee system cleared via premarket notification K102069 and K061011. The device subject of this premarket notification is a modification to the aforementioned device.
| Table 1: Substantially Equivalent Predicates to the Journey II Uni Tibial baseplates | |
|---|---|
| and inserts |
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|-------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Journey Uni tibial baseplates | K102069 | 10/5/2010 |
| Smith & Nephew | Competitor Unicondylar Tibial
Baseplate Components | K061011 | 07/11/2006 |
| Smith & Nephew, Inc. | Journey II XR Knee System | K141471 | 11/14/2014 |
| Smith & Nephew, Inc. | GENESIS Unicompartmental
Knee System | K912735 | 12/27/1991 |
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The substantial equivalence of the subject devices are 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 Uni | Journey Uni
Tibial Base | Journey Uni
Insert
(Competitor) | Journey II XR
(reference
predicate) | GENESIS Uni
Insert
(reference
predicate) |
|---------------------------------------------|--------------------------------|----------------------------|---------------------------------------|-------------------------------------------|---------------------------------------------------|
| 510(k) Number | Subject 510(k) | K1020269 | K061011 | K141471 | K912735 |
| Manufacturer | Smith & Nephew,
Inc. | Smith & Nephew,
Inc. | Smith &
Nephew, Inc. | Smith &
Nephew, Inc. | Smith &
Nephew, Inc. |
| Similar
Indications for
Use | Yes- HSX | Yes-HSX | Yes-HSX | No- JWH | Yes- HSX |
| Similar
Sterilization
Methods | ETO/Gamma | Yes | Yes | Yes | Yes |
| Unicondylar
Design | Yes | Yes | Yes | No (Total knee) | Yes |
| Insert material | XLPE | N/A | UHMWPE | XLPE | UHMWPE |
| Similar
Locking
Mechanism | Anterior/Posterior
snap fit | Yes | Yes | Yes | Medial/Lateral
snap fit |
| Similar
Articular
Surface
Geometry | Non-conforming | N/A | No (flat) | No (Conforming) | Non-conforming |
| Tibial base
material | Ti-6Al-4V | Ti-6Al-4V | N/A | Ti-6Al-4V | N/A |
| Similar
Manufacturing
Process | Yes | Yes | Yes | Yes | Yes |
Table 2: Comparison to Substantially Equivalent Devices
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Journey II Uni tibial baseplate and inserts, which are modifications of existing Smith & Nephew Unicondylar tibial baseplates and inserts. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the above predicate knee systems.