(86 days)
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.
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).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Journey CR Knee System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission for the Smith & Nephew Journey CR Knee System (K101499) does not explicitly list quantitative "acceptance criteria" in the way a diagnostic AI device would. Instead, it refers to a "review of the mechanical data indicates that the Journey CR Knee System is capable of withstanding expected in vivo loading without failure" and that "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."
The "performance" is demonstrated through various mechanical tests, implicitly aiming to show the device is as safe and effective as its predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstanding expected in vivo loading without failure. | Mechanical testing of the Journey CR Knee system was performed on: - Journey CR femoral lugs (mechanical testing, removal torque, push-out and torque to failure) - Journey CR tibial insert locking mechanism (static testing) - Tibiofemoral contact area analysis - Tibiofemoral constraint testing - Patellofemoral contact area analysis - Patellofemoral lateral subluxation Conclusion: "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
| Substantial equivalence to predicate devices in safety and effectiveness. | The submission states that "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." This is supported by the mechanical testing results, which are deemed sufficient to show no new issues. |
2. Sample Size Used for the Test Set and Data Provenance
This is a medical device (knee implant), not a diagnostic AI algorithm. Therefore, the concept of a "test set" with clinical data provenance does not directly apply in the same way. The evaluation relies on mechanical testing of the device components.
- Sample Size for Test Set: Not specified in terms of number of patient cases. The testing was performed on physical components of the Journey CR Knee System. The document implies a sufficient number of samples were tested to gain confidence in the mechanical properties, but the exact number isn't stated.
- Data Provenance: The "data" comes from in vitro mechanical tests conducted on the physical device components. There is no mention of country of origin for clinical data, as clinical data was not required for this submission. The study is in vitro (bench testing) rather than retrospective or prospective clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Again, this is a mechanical device, not an AI diagnostic. Therefore, the concept of "ground truth" derived from expert consensus on patient data is not applicable. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The experts involved would be qualified engineers and test technicians in a laboratory setting, but their number and specific qualifications are not detailed in this regulatory document.
4. Adjudication Method for the Test Set
Not applicable, as this is a mechanical device undergoing bench testing, not a clinical study involving human readers or expert consensus on medical images. The "adjudication" is implicitly done by the engineers and regulatory affairs personnel reviewing the raw mechanical test data against established engineering principles and relevant standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a knee prosthesis, not an AI diagnostic system. There were no human readers or AI involved in the evaluation of this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop) performance study was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device evaluation is based on mechanical engineering principles, established material properties, and standardized mechanical testing protocols designed to simulate in vivo loading conditions. The performance is compared against known characteristics of predicate devices that have a history of safe and effective use.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no AI model with a training set. The "design" and "development" of the device would involve engineering iterations, but these are not referred to as a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI model or training set, this question is not relevant. The "ground truth" for engineering design would be based on biomechanical principles, clinical requirements for knee function, material science, and the performance characteristics of existing, successful knee implants.
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K101499 (1 of 2)
. We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 | AUG 2 6 2010 |
|---|---|---|
| Date of Summary: | August 25, 2010 | |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075 | |
| Name of Device: | Smith & Nephew, Inc. Journey CR Knee System | |
| Common Name: | Knee prosthesis | |
| Device Classification Name andReference: | 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis | |
| 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
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- 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 | SubmissionNumber | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | Genesis II Knee System | K951987 | 8/22/1995 |
| Zimmer | Nexgen Complete Knee SolutionCruciate Retaining (CR)-FlexFemoral Components | K023211 | 10/17/2002 |
| Smith & Nephew, Inc. | Genesis II Deep Flexion CruciateRetaining 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 OrthopaedicsInc. | 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.
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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
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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
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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
§ 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.