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.

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.

AI/ML Overview

This document pertains to the clearance of a medical device, specifically the Journey II Uni Tibial Base and Insert, a unicompartmental knee implant. The information provided outlines the reasoning for its substantial equivalence to previously cleared devices rather than a study designed to meet specific acceptance criteria for a novel device. Therefore, many of the requested fields regarding acceptance criteria and study details are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the form of quantitative thresholds for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing and design similarities. The "performance" reported is that the device is equivalent to existing, legally marketed predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical equivalence to predicate devices	"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."
No new issues related to safety and effectiveness	"and that there are no new issues related to the safety and effectiveness of the subject device(s)."

2. Sample sized used for the test set and the data provenance

Sample Size: The document lists types of mechanical tests performed (Unsupported Baseplate Fatigue Testing, Static testing of the insert locking mechanism, Fully Supported Fatigue/Cement Adhesion Testing, Contact Area Analysis). However, it does not specify the sample sizes used for these tests.
Data Provenance: The data is generated from mechanical verification testing/analysis conducted by Smith & Nephew, Inc. It is not clinical data, nor is its country of origin or retrospective/prospective nature specified, as these are mechanical tests, not human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The ground truth for mechanical testing is based on engineering principles and established testing standards, not expert consensus as in diagnostic accuracy studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as there is no human interpretation or adjudication involved in the mechanical tests described.

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

This section is not applicable. This submission is for a knee implant, not an AI-powered diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the assessment of this device is its mechanical performance relative to established predicate devices, as determined by engineering tests and analyses, adhering to relevant standards for medical device design and manufacturing.

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable. No training set was used.

Summary

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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

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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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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 Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 15, 2015
Contact Person and Address:	Brad ShealsPrincipal Regulatory Affairs SpecialistT 901-399-6897F 901-566-7911
Name of Device:	Smith & Nephew, Inc. Journey II Uni Tibial Baseplateand Insert
Common Name:	Knee Prosthesis
Device Classification Name andReference:	21 CFR 888.3520 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HSX

Device Description

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.

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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	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	Journey Uni tibial baseplates	K102069	10/5/2010
Smith & Nephew	Competitor Unicondylar TibialBaseplate Components	K061011	07/11/2006
Smith & Nephew, Inc.	Journey II XR Knee System	K141471	11/14/2014
Smith & Nephew, Inc.	GENESIS UnicompartmentalKnee 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 AspectReviewed	Journey II Uni	Journey UniTibial Base	Journey UniInsert(Competitor)	Journey II XR(referencepredicate)	GENESIS UniInsert(referencepredicate)
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.
SimilarIndications forUse	Yes- HSX	Yes-HSX	Yes-HSX	No- JWH	Yes- HSX
SimilarSterilizationMethods	ETO/Gamma	Yes	Yes	Yes	Yes
UnicondylarDesign	Yes	Yes	Yes	No (Total knee)	Yes
Insert material	XLPE	N/A	UHMWPE	XLPE	UHMWPE
SimilarLockingMechanism	Anterior/Posteriorsnap fit	Yes	Yes	Yes	Medial/Lateralsnap fit
SimilarArticularSurfaceGeometry	Non-conforming	N/A	No (flat)	No (Conforming)	Non-conforming
Tibial basematerial	Ti-6Al-4V	Ti-6Al-4V	N/A	Ti-6Al-4V	N/A
SimilarManufacturingProcess	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.

Regulation Number and Section

§ 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.