(86 days)
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a total knee replacement system used to treat conditions like arthritis and failed previous knee replacements, making it a therapeutic device designed to restore knee function and alleviate symptoms.
No
Explanation: This document describes a total knee replacement system, which is an implantable medical device used to treat joint conditions, not to diagnose them. Its intended use is for treatment, not diagnostic purposes.
No
The device description clearly outlines physical components made of materials like OXINIUM, cobalt chrome, and UHMWPE, which are hardware. The performance studies also focus on mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for treating various conditions of the knee joint (rheumatoid arthritis, osteoarthritis, etc.) by replacing components of the knee. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details physical components like femoral components, articular inserts, tibial trays, and patellar components, all designed to be implanted in the knee.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on in vitro testing.
This device is a surgical implant used for total knee replacement.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthrilis; failed osteotomies, unicompartmental replacement, or total knee replacement.
Smith & Nephew, Inc. Journey CR 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 510(k) premarket notification is the Journey. CR Knee System. The subject device is a cruciate retaining (CR) total knee system which is designed to provide the potential ability for greater flexion to those patients who have the anatomic capability to allow a greater flexion range. Components of this premarket notification include the following components:
- Cruciate retaining femoral components available in sizes 1-10 in right and left designs in . OXINIUM material.
- Cruciate retaining femoral components available in sizes 1-9 in right and left designs in cobalt – chrome material
- Cruciate retaining articular inserts available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left . designs. Journey CR articular inserts will be offered in 9-21mm thicknesses (9, 10, 11, 13, 15, 18, 21) and manufactured from UHMWPE.
The Journey CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with 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
Not Found
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)
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 CR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey CR Knee system was performed:
- Mechanical testing, removal torque, push-out and torque to failure of the Journey CR femoral . lugs
- Static testing of the Journey CR tibial insert locking mechanism .
- Tibiofemoral contact area analysis .
- Tibiofemoral constraint testing
- Patellofemoral contact area analysis
- Patellofemoral lateral subluxation
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 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.
K951987, K023211, K041825, K040267, K042515, K062654
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
K101499 (1 of 2)
. We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 | AUG 2 6 2010 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| Date of Summary: | August 25, 2010 | |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist
T (901) 399-6325 F (901) 566-7075 | |
| Name of Device: | Smith & Nephew, Inc. Journey CR Knee System | |
| Common Name: | Knee prosthesis | |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis | |
| Device Class: | Class II | |
| Panel Code: | Orthopaedics/87 | |
| Product Code: | JWH | |
Device Description
Subject of this Abbreviated 510(k) premarket notification is the Journey. CR Knee System. The subject device is a cruciate retaining (CR) total knee system which is designed to provide the potential ability for greater flexion to those patients who have the anatomic capability to allow a greater flexion range. Components of this premarket notification include the following components:
- Cruciate retaining femoral components available in sizes 1-10 in right and left designs in . OXINIUM material.
- Cruciate retaining femoral components available in sizes 1-9 in right and left designs in cobalt � chrome material
- Cruciate retaining articular inserts available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left . designs. Journey CR articular inserts will be offered in 9-21mm thicknesses (9, 10, 11, 13, 15, 18, 21) and manufactured from UHMWPE.
The Journey CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with 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 CR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey CR Knee system was performed:
- Mechanical testing, removal torque, push-out and torque to failure of the Journey CR femoral . lugs
- Static testing of the Journey CR tibial insert locking mechanism .
- Tibiofemoral contact area analysis .
Confidential
1
- Tibiofemoral constraint testing
- Patellofemoral contact area analysis
- Patellofemoral lateral subluxation
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 safety and effectiveness of the subject devices.
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthrilis; failed osteotomies, unicompartmental replacement, or total knee replacement.
Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.
Substantial Equivalence Information
The substantial equivalence of the Journey CR Knee System is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate systems listed in the table below.
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------------|-------------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Genesis II Knee System | K951987 | 8/22/1995 |
| Zimmer | Nexgen Complete Knee Solution
Cruciate Retaining (CR)-Flex
Femoral Components | K023211 | 10/17/2002 |
| Smith & Nephew, Inc. | Genesis II Deep Flexion Cruciate
Retaining Articular Insert | K041825 | 7/6/2004 |
| Howmedica, Inc | Triathlon Cruciate Retaining (CR)
Total Knee | K040267 | 5/5/2004 |
| Smith & Nephew | High Performance Knee¹ | K042515 | 3/14/2005 |
| DePuy Orthopaedics
Inc. | Sigma Cruciate Retaining (C/R)
Porocoat® Femoral Components | K062654 | 9/29/2006 |
Conclusion
As previously noted, this Abbreviated 510|k) Premarket Notification is being submitted to request clearance for the Journey CR Knee System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate knee systems.
l The High Performance Knee System cleared via K042515 is now marketed by Smith & Nephew as the Journey BCS Knee System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Orthopaedic Division % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
AUG 2 6 2010
Re: K101499
Trade Name: Journey CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis
Regulatory Class: II Product Code: JWH Dated: May 27, 2010 Received: June 12, 2010
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 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/ucm1158001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 3 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Proc 807.97). For questions regarding the reporting of adverse events under the MDR regultivn (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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K111499
Premarket Notification Indications for Use Statement
510(k) Number (if known): K101499
Device Name: Journey 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.
Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.
Prescription Use _ X (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onita for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101499
Page 1 of _ 1