Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthrilis, or degenerative arthritis; failed osteotomies, unicompartment, 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.

Device Description

Subject of this Traditional Premarket Notification are the Journey II Deep Dished articular inserts. The Journey II Deep Dished articular insert is a cruciate stabilizing tibial insert that is intended to be used with the Journey II BCS (K111711) and Journey BCS (K042515) knee systems when the posterior cruciate ligament (PCL) is sacrificed and an insert with a post is not a viable option for the patient. Components of this premarket notification include:

Cruciate substituting (deep dished) articular inserts which will initially be available in sizes 1-2, . 3-4, 5-6, and 7-8 in right and left designs. Journey II Deep Dished inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (7.5 Mrad XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
. Cruciate substituting (deep dished) articular insert trial implants manufactured from Radel.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Journey II Deep Dished Articular Inserts:

Acceptance Criteria and Device Performance

The provided document describes the Journey II Deep Dished Articular Insert as a cruciate stabilizing tibial insert. The acceptance criteria are indirectly established through mechanical testing designed to demonstrate the device's capability to withstand "expected in vivo loading without failure."

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Withstand expected in vivo loading without failure	"Capable of withstanding expected in vivo loading without failure."
Demonstrate proper tibiofemoral contact area	Tibiofemoral Contact Area Analysis performed
Demonstrate sufficient tibiofemoral constraint	Tibiofemoral Constraint Testing performed
Ensure no new issues related to safety and effectiveness compared to predicates	"A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

Note: The document does not explicitly state quantitative acceptance criteria (e.g., minimum load capacity, specific contact area values, or constraint ranges). Instead, it refers to the performance by indicating that the device "is capable of" meeting the implicit criteria.

Study Details

The document refers to mechanical testing that was performed to support the substantial equivalence of the new device to previously cleared predicate devices.

1. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (number of inserts tested) for the mechanical tests.
The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. However, as this is a 510(k) submission to the U.S. FDA, the testing was likely conducted in accordance with recognized U.S. or international standards for medical device testing.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the described studies are mechanical bench tests, not clinical studies involving human subject data or expert assessment for ground truth.

3. Adjudication Method for the Test Set

This information is not applicable for mechanical bench tests.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable. The submission focuses on the mechanical properties and substantial equivalence to predicate devices, not on the improvement of human reader performance with or without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not performed, nor is it applicable. The device is a physical knee implant component, not an algorithm or AI-powered system meant for diagnostic or assistive purposes.

6. Type of Ground Truth Used

The "ground truth" for the mechanical tests would be the physical measurements and observations derived directly from the laboratory testing (e.g., force-displacement curves, contact area measurements, failure modes). This is an objective, empirically derived ground truth based on engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.

7. Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

8. How the Ground Truth for the Training Set Was Established

This information is not applicable as no training set was used.

Summary

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Ne are smith&nephew

FEB 27 2012

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	February 21, 2012
Contact Person and Address:	Shereen Myers, Senior Regulatory Affairs SpecialistT (901) 399-6325 >JWH

Device Description

Cruciate substituting (deep dished) articular inserts which will initially be available in sizes 1-2, . 3-4, 5-6, and 7-8 in right and left designs. Journey II Deep Dished inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (7.5 Mrad XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
. Cruciate substituting (deep dished) articular insert trial implants manufactured from Radel.

Technological Characteristics

A review of the mechanical data indicates that the Journey II Deep Dished Articular Insert is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II Deep Dished inserts was performed:

Tibiofemoral Contact Area Analysis ●
. Tibiofemoral Constraint Testing

A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Due to the similarities to predicate devices, no additional biocompatibility or mechanical testing was required to support the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

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Intended Use

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 Deep Dished Articular Inserts is 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 IIDeepDishedInserts	Journey။ BCSKneeSystem	HighPerformanceKnee System	VKS KneeSystem	ProfixContormingPlus TibialInsert	Profix FlexCruciateRetainingArticularInsert	Genesis IITotal KneeSystem
510(k) Number	Subject510(k)	K111711	K042515	K022204	K946236	K051229	K951987
Manufacturer	Smith &Nephew, Inc	Smith &Nephew,Inc	Smith &Nephew, Inc	PlusOrthopaedics	Smith &Nephew, Inc.	Smith &Nephew,Inc.	Smith &Nephew,Inc.
SimilarIndications forUse	Subjectdevice	Y	Y	N	Y	Y	Y
Dished Insert(CruciateSubstituting)	Y	N	N	Y	Y	N	Y
SimilarSterilizationMethod	Subjectdevice	Y	Y	Y	Y	Y	Y
Material	XLPE andUHMWPE	ArticularInserts -XLPEandUHMWPE	ArticularInserts -UHMWPE	ArticularInserts -UHMWPE	ArticularInserts -UHMWPE	ArticularInserts -UHMWPE	ArticularInserts -UHMWPE
SimilarManufacturingProcess	Subjectdevice	Y	Y	Y	Y	Y	Y

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 Deep Dished Articular Inserts. 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 7 2012

Smith & Nephew. Inc. % Ms. Shereen Myers Senior Regulatory Affairs Specialist 1450 East Brooks Road Memphis. Tennessee 38116

Re: K113482

Trade/Device Name: Journey II Deep Dished Articular Inserts

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: February 21, 2012 Received: February 23, 2012

Dear Ms. Myers:

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.

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

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Page 2 - Ms. Shereen Myers

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours,

Erinal Keith

Mark N. Melkerson Director . Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

KII 3482 510(k) Number (if known): __

Device Name: Journey II Deep Dished Articular Inserts

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. 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.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Diysion Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113482

Regulation Number and Section

§ 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.