(96 days)
No
The summary describes a mechanical knee implant component and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device components are indicated for various forms of arthritis and failed knee replacements, aiming to restore knee function, which directly addresses a health condition.
No
The document describes a medical implant (Journey II Deep Dished articular inserts for total knee replacement) and its mechanical testing, not a device used to diagnose a medical condition.
No
The device description clearly states the device is a physical implant (articular inserts) made from polyethylene and Radel, intended for surgical implantation in the knee. It also describes mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a "Cruciate substituting (deep dished) articular insert" for a total knee system. This is a physical implant designed to be surgically placed within the knee joint.
- Intended Use: The intended use describes the conditions for which the total knee components are indicated (rheumatoid arthritis, osteoarthritis, etc.) and the specific use of the articular inserts in primary and revision surgery. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a medical device, specifically a surgical implant, used to treat conditions affecting the knee joint. It does not perform any diagnostic function on samples taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111711, K042515, K022204, K946236, K051229, K951987
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Ne are smith&nephew
FEB 27 2012
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | February 21, 2012 |
| Contact Person and Address: | Shereen Myers, Senior Regulatory Affairs Specialist
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
Reviewed | Journey II
Deep
Dished
Inserts | Journey
။ BCS
Knee
System | High
Performance
Knee System | VKS Knee
System | Profix
Contorming
Plus Tibial
Insert | Profix Flex
Cruciate
Retaining
Articular
Insert | Genesis II
Total Knee
System |
|---------------------------------------------|-----------------------------------------|-------------------------------------------------|------------------------------------|----------------------------------|-----------------------------------------------|-------------------------------------------------------------|------------------------------------|
| 510(k) Number | Subject
510(k) | K111711 | K042515 | K022204 | K946236 | K051229 | K951987 |
| Manufacturer | Smith &
Nephew, Inc | Smith &
Nephew,
Inc | Smith &
Nephew, Inc | Plus
Orthopaedics | Smith &
Nephew, Inc. | Smith &
Nephew,
Inc. | Smith &
Nephew,
Inc. |
| Similar
Indications for
Use | Subject
device | Y | Y | N | Y | Y | Y |
| Dished Insert
(Cruciate
Substituting) | Y | N | N | Y | Y | N | Y |
| Similar
Sterilization
Method | Subject
device | Y | Y | Y | Y | Y | Y |
| Material | XLPE and
UHMWPE | Articular
Inserts -
XLPE
and
UHMWPE | Articular
Inserts -
UHMWPE | Articular
Inserts -
UHMWPE | Articular
Inserts -
UHMWPE | Articular
Inserts -
UHMWPE | Articular
Inserts -
UHMWPE |
| Similar
Manufacturing
Process | Subject
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