(126 days)
No
The document describes a mechanical surgical instrument with a design modification and bench testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as an accessory instrument (Tibial Posterior Keel Punch) used to assist in the implantation of a knee system, not the knee system itself. It prepares the bone for the implant.
No
The device is described as an accessory device and reusable instrument intended to assist in the implantation of a total knee system, specifically to prepare for the posterior keel of the tibia baseplate implant. Its function is mechanical preparation and guiding, not diagnosing a condition or disease.
No
The device description explicitly states it is a "design modification (i.e. tip geometry) to the Journey II XR Tibial Posterior Keel Punch," which is a reusable instrument used to prepare for implanting a knee system. This describes a physical, hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Journey II XR Instruments are "accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System". This describes a surgical instrument used during a procedure on a patient.
- Device Description: The description details a "Tibial Posterior Keel Punch" which is a "reusable instrument" used to "prepare for the posterior keel of the tibia baseplate implant". This is a tool for physical manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide medical information. This device is a surgical instrument used directly on the patient during a knee replacement procedure.
N/A
Intended Use / Indications for Use
Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
Product codes
JWH
Device Description
The subject of this Traditional 510(k) is a design modification (i.e. tip geometry) to the Journey II XR Tibial Posterior Keel Punch. The Journey II XR Tibial Posterior Keel Punch are reusable instrument and are intended to be used to prepare for the posterior keel of the tibia baseplate implant and act as a guide for the Anterior Keel Punch. The Journey II XR Keel Punch were previously cleared for market notification K173331.
The Journey II XR Keel Punch are available in same size range as the predicate.
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)
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the Journey II XR Keel Punch. A review of the mechanical data and the technical memo, indicates that the Journey II XR Keel Punch are substantially equivalent to predicate devices listed in the Table above.
The following tests were used as a basis for the determination of substantial equivalence.
- Finite Element Analysis .
- . Stress Distribution Test
A review of the above testing demonstrated that there are no new issues related to the safety and effectiveness of the subject device and will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 4, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Brad Sheals, MS Senior Regulatory Affairs Specialist Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K200227
Trade/Device Name: Journey II XR Knee Instrument Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 11, 2020 Received: May 12, 2020
Dear Brad Sheals:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200227
Device Name JOURNEY II XR Knee Instruments
Indications for Use (Describe)
Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray, and "smith&nephew" in orange. The text is aligned horizontally, creating a clean and professional look.
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | June 3, 2020 |
| Contact Person: | Brad Sheals, Regulatory Affairs Manager
T (901) 399-6897
F (901) 566-7911 |
| Name of Device: | Journey II XR Knee Instrument |
| Common Name: | Knee Instrument |
| 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 |
| Predicate Device: | Smith & Nephew, Inc. Journey II XR Knee System
Instruments - K173331 |
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Image /page/4/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
Device Description:
The subject of this Traditional 510(k) is a design modification (i.e. tip geometry) to the Journey II XR Tibial Posterior Keel Punch. The Journey II XR Tibial Posterior Keel Punch are reusable instrument and are intended to be used to prepare for the posterior keel of the tibia baseplate implant and act as a guide for the Anterior Keel Punch. The Journey II XR Keel Punch were previously cleared for market notification K173331.
The Journey II XR Keel Punch are available in same size range as the predicate.
Indication for Use:
Journey II XR Instruments are accessory devices and intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication 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.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
The above indications are substantially equivalent to the indications cleared for the Smith & Nephew, Inc. Journey II XR Knee System Instruments cleared under K173331. The Smith & Nephew Journey II XR Total Knee systems were cleared under K141471 and K152726.
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Image /page/5/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject device Journey II XR Keel Punch are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.
Substantial Equivalence Information
As confirmed in the table below, the overall design, indications for use and sterilization for the subject Journey II XR Keel Punch is substantially equivalent to the following commercially available predicate device.
| Design
Features | Subject Journey II XR Tibial
Posterior Keel Punch | Predicate Journey II XR Tibial
Posterior Keel Punch |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Smith & Nephew, Inc. | Smith & Nephew, Inc
K173331 SE 11/16/2017 |
| Indication for
Use | Journey II XR Instruments are
accessory devices and intended to be
used to assist in the implantation of
Smith & Nephew Journey II XR Knee
systems and their cleared indication
for use | Journey II XR Instruments are
accessory devices and intended to be
used to assist in the implantation of
Smith & Nephew Journey II XR Knee
systems and their cleared indication 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. | Total knee components are indicated
for rheumatoid arthritis; post-traumatic
arthritis, osteoarthritis, or degenerative
arthritis;
failed osteotomies,
unicompartmental replacement, or total
knee replacement. |
| | The Journey II Total Knee system
components are indicated for use only
with cement and are single use
devices. | The Journey II Total Knee system
components are indicated for use only
with cement and are single use devices. |
| Material | Stainless Steel | Stainless Steel |
| Coating | Chrome Coat | Chrome Coat |
| Sizes | Same | Same |
| | 1-2, 3-4, 5-6, 7-8 | 1-2, 3-4, 5-6, 7-8 |
| Sterilization | Non-sterile | Non-sterile |
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Image /page/6/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
Performance Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the Journey II XR Keel Punch. A review of the mechanical data and the technical memo, indicates that the Journey II XR Keel Punch are substantially equivalent to predicate devices listed in the Table above.
The following tests were used as a basis for the determination of substantial equivalence.
- Finite Element Analysis .
- . Stress Distribution Test
A review of the above testing demonstrated that there are no new issues related to the safety and effectiveness of the subject device and will perform as intended.
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted for a design modification to the Journey II XR Tibial Posterior Keel Punch. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.