JOURNEY II DEEP DISHED ARTICULAR INSERTS
Device Facts
| Record ID | K113482 |
|---|---|
| Device Name | JOURNEY II DEEP DISHED ARTICULAR INSERTS |
| Applicant | Smith & Nephew, Inc. |
| Product Code | JWH · Orthopedic |
| Decision Date | Feb 27, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Journey II Deep Dished articular inserts are cruciate-substituting tibial components for knee arthroplasty. Designed for use with Journey II BCS and Journey BCS knee systems when the posterior cruciate ligament (PCL) is sacrificed and a post-style insert is not viable. Manufactured from 7.5 Mrad cross-linked polyethylene (XLPE) or conventional UHMWPE; trial implants made of Radel. Used in clinical settings by orthopedic surgeons during primary or revision knee surgery. Components are cemented in place. Inserts provide a bearing surface to restore joint function and stability in patients with ligamentous incompetence. Benefits include improved joint kinematics and stability for patients where standard cruciate-retaining options are unsuitable.
Clinical Evidence
Bench testing only. No clinical data was required or provided to support the safety and effectiveness of the subject devices. Mechanical testing included tibiofemoral contact area analysis and tibiofemoral constraint testing.
Technological Characteristics
Cruciate-substituting (deep dished) tibial articular inserts. Materials: 7.5 Mrad cross-linked polyethylene (XLPE) and conventional UHMWPE. Trial implants: Radel. Form factor: Sizes 1-8, thicknesses 9-21 mm. Energy source: N/A (mechanical). Connectivity: N/A. Sterilization: Consistent with predicate devices.
Indications for Use
Indicated for patients requiring primary or revision total knee arthroplasty due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, or following failed osteotomies, unicompartmental, or total knee replacement, specifically where anterior and posterior cruciate ligaments are incompetent and collateral ligaments remain intact.
Regulatory Classification
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).
Predicate Devices
- Journey II BCS Knee System (K111711)
- High Performance Knee System (K042515)
- VKS Knee System (K022204)
- Profix Conforming Plus Tibial Insert (K946236)
- Profix Flex Cruciate Retaining Articular Insert (K051229)
- Genesis II Total Knee System (K951987)
Related Devices
- K211671 — Journey II Mid-Level Tibial Inserts · Smith & Nephew, Inc. · Aug 17, 2021
- K023724 — DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT · Howmedica Osteonics Corp. · Feb 3, 2003
- K021451 — DURACON CS TIBIAL INSERT · Howmedica Osteonics Corp. · Oct 18, 2002
- K110837 — REVISION PROTHESIS · Smith & Nephew, Inc. · Apr 22, 2011
- K050539 — SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT · Howmedica Osteonics Corp. · Mar 29, 2005
Submission Summary (Full Text)
{0}------------------------------------------------
Ne are smith&nephew
FEB 27 2012
| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | February 21, 2012 |
| Contact Person and Address: | Shereen Myers, Senior Regulatory Affairs Specialist<br>T (901) 399-6325 >JWH |
# 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.
# 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.
1
{1}------------------------------------------------
### Intended Use
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.
### 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 Aspect<br>Reviewed | Journey II<br>Deep<br>Dished<br>Inserts | Journey<br>။ BCS<br>Knee<br>System | High<br>Performance<br>Knee System | VKS Knee<br>System | Profix<br>Contorming<br>Plus Tibial<br>Insert | Profix Flex<br>Cruciate<br>Retaining<br>Articular<br>Insert | Genesis II<br>Total Knee<br>System |
|---------------------------------------------|-----------------------------------------|-------------------------------------------------|------------------------------------|----------------------------------|-----------------------------------------------|-------------------------------------------------------------|------------------------------------|
| 510(k) Number | Subject<br>510(k) | K111711 | K042515 | K022204 | K946236 | K051229 | K951987 |
| Manufacturer | Smith &<br>Nephew, Inc | Smith &<br>Nephew,<br>Inc | Smith &<br>Nephew, Inc | Plus<br>Orthopaedics | Smith &<br>Nephew, Inc. | Smith &<br>Nephew,<br>Inc. | Smith &<br>Nephew,<br>Inc. |
| Similar<br>Indications for<br>Use | Subject<br>device | Y | Y | N | Y | Y | Y |
| Dished Insert<br>(Cruciate<br>Substituting) | Y | N | N | Y | Y | N | Y |
| Similar<br>Sterilization<br>Method | Subject<br>device | Y | Y | Y | Y | Y | Y |
| Material | XLPE and<br>UHMWPE | Articular<br>Inserts -<br>XLPE<br>and<br>UHMWPE | Articular<br>Inserts -<br>UHMWPE | Articular<br>Inserts -<br>UHMWPE | Articular<br>Inserts -<br>UHMWPE | Articular<br>Inserts -<br>UHMWPE | Articular<br>Inserts -<br>UHMWPE |
| Similar<br>Manufacturing<br>Process | Subject<br>device | 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.
{2}------------------------------------------------
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
{3}------------------------------------------------
# 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
{4}------------------------------------------------
# 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
