(90 days)
No
The summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not analyses of data or images.
Yes
The device is a total knee system indicated for various forms of arthritis and failed joint replacements, which are conditions that impair normal body function and require intervention to restore or replace that function.
No
Explanation: This device is a total knee replacement system, which is a prosthetic implant used in orthopedic surgery to replace a damaged knee joint. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like OXINIUM, cobalt chrome, and polyethylene, which are hardware. There is no mention of software as the primary or sole component.
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 treating various forms of arthritis and failed previous knee surgeries. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components of a knee replacement system (femoral components, articular inserts, tibial tray, patellar components). IVD devices are typically reagents, kits, or instruments used to analyze biological samples.
- Performance Studies: The performance studies focus on mechanical testing of the implant's strength and function (contact area analysis, constraint testing). IVD performance studies would involve evaluating the accuracy and reliability of a test to detect a specific condition or substance in a biological sample.
The device described is a total knee replacement system, which is a type of surgical implant.
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 Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:
- Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and . left designs in OXINIUM material.
- Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and . left designs in cobalt chrome material
- Cruciate retaining 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 CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE.
The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)
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)
The following mechanical testing of the Journey II CR Knee system was performed:
- Patellofemoral Contact Area Analysis
- Tibiofemoral Contact Area Analysis
- Patellofemoral Resistance to Lateral Subluxation ♥
- 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. Clinical data was not needed to support the safely 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.
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.
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
We are smith&nephew
Submitted by:
Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
1 3 2012 AUG
Date of Summary:
Name of Device: Common Name:
Contact Person and Address:
Device Classification Name and
July 25, 2012
Shereen Myers, Senior Regulatory Affairs Specialist T (901) 399-6325 F (901) 566-7075
Smith & Nephew, Inc Journey II CR Knee System
Knee prosthesis
Orthopaedics/87
21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Device Class:
Panel Code:
Reference:
Product Code:
JWH
Class II
Device Description
Subject of this Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:
- Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and . left designs in OXINIUM material.
- Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and . left designs in cobalt chrome material
- Cruciate retaining 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 CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE.
The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)
Technological Characteristics
This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. A review of the mechanical data indicates that the Journey II CR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II CR Knee system was performed:
- Patellofemoral Contact Area Analysis
- Tibiofemoral Contact Area Analysis
1
- Patellofemoral Resistance to Lateral Subluxation ♥
- 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. Clinical data was not needed to support the safely and effectiveness of the subject devices
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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.
Substantial Equivalence Information
The substantial equivalence of the Journey II CR Knee system 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 CR Knee System | Journey II BCS Knee
System | Journey CR Knee System |
|-------------------------------------|-------------------------------------------------------|-------------------------------------------------------|----------------------------------------------|
| 510(k) Number | Subject 510(k) | K111711 | K101499 |
| Manufacturer | Smith & Nephew, Inc | Smith & Nephew, Inc | Smith & Nephew, Inc |
| Similar Indications
for Use | Subject device | Y | Y |
| Insert Locking
Mechanism | Y | Y | Y |
| Similar Sterilization
Method | Subject device | Y | Y |
| Material | Femoral - OXNIUM and CoCr
Insert - XLPE and UHMWPE | Femoral - OXNIUM and CoCr
Insert - XLPE and UHMWPE | Femoral - OXNIUM and CoCr
Insert - UHMWPE |
| Similar
Manufacturing
Process | Subject device | Y | Y |
Table 1: Comparison to Substantially Equivalent Devices
Conclusion
As previously noted, this Abbreviated 510{k} Premarket Notification is being submitted to request clearance for the Journey II CR Knee System. 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 Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 3 2012
Smith & Nephew, Inc. % Ms. Shereen Myers Senior Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K121443
Trade/Device Name: Journey II CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II
Product Code: JWH Dated: May 14, 2012 Received: May 15, 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. 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
3
Page 2 - Ms. Shereen Myers
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erica 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
121443 510(k) Number (if known):
Device Name: Journey II CR Knee System
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)
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K121443 |
|---|---|
| --------------- | --------- |