(77 days)
No
The summary describes a mechanical knee implant and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a total knee component, is used to treat conditions like rheumatic arthritis and osteoarthritis, which are diseases or injuries, classifying it as a therapeutic device.
No
The device description indicates it is a component of a total knee replacement system, which is a therapeutic device, not a diagnostic one. Its intended use is for conditions like arthritis, not for diagnosing them.
No
The device description clearly states it consists of physical components (tibial inserts) made of XLPE, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "Total knee component" consisting of "Tibial Inserts." These are implants designed to be surgically placed within the body.
- Intended Use: The intended use describes the conditions for which the knee components are indicated (arthritis, failed replacements) and how they function within the knee joint. This is a description of a surgical implant, not a diagnostic test.
The information provided describes a medical device used for treatment (surgical implantation), not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicoment, 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.
Product codes
JWH
Device Description
The Smith & Nephew Journey II Mid-Level Tibial Inserts consist of Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9mm-21mm) and Journey II Medial Dished XLPE Articular Inserts Size 1-8 Right and Left (9-18mm).
The Smith & Nephew Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9-21mm) are line additions to the existing Journey II BCS XLPE Articular Inserts Size 1-8 Right and Left (9-21mm) and the Journey II BCS Constrained Articular Inserts Size 1-8 Right and Left (9-25mm) cleared via premarket notification K111711 and K140555, respectively.
The Smith & Nephew Journey II Medial Dished XLPE Articular Insert Size 1-8 Right and Left 9-18mm are line additions to the existing Journey II CR XLPE Articular Insert Size 1-8 Right and Left (9-18mm) and the Journey II Insert XLPE Deep Dished Right and Left Size 1-8 (9-21mm) cleared via premarket notification K121443 and K113482, respectively.
The Journey II Articular Stabilized XLPE Articular Inserts offers total knee arthroplasty patients with soft tissue structures on the lateral side of the knee increased laxity an additional level of conformity to provide needed stability. The Journey II Articular Stabilized XLPE Articular Inserts provide additional posterolateral A/P stability compared to Journey II BCS but without the varus/valgus constraint provided by the more robust Journey II BCS Constrained post.
The Journey II Medial Dished XLPE Articular Inserts offers total knee arthroplasty patients having insufficient posterior cruciate ligament (PCL) function an additional level of medial anterior/posterior constraint over existing Journey II CR XLPE Articular Inserts while seeking to promote improved kinematics and lateral femoral rollback compared to the more constraining Journey II Inserts XLPE Deep Dished.
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, various types of preclinical testing were conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices described in Table 6.1 above. A review of the testing indicates that the Journey II Mid-Level Tibial Inserts are substantially equivalent to predicate devices listed in above. The specific types of pre-clinical testing include:
- Finite Element Analysis of the Post Strength of the Journey II Articular . Stabilized (AS) Insert as Compared to the Journey II Bi-Cruciate Stabilized (BCS) Insert (OR-20-140) - The primary goal of this study was to evaluate the structural strengths of the Journey II Articular Stabilized (AS) Insert Implants. Maximum principal stresses were calculated using Finite Element Analysis (FEA).
- Anterior/Posterior (A/P) 30° Fatigue Testing of the Journey II Articular . Stabilized (AS) Size 5-6 Tibial Insert (OR-21-058) – The purpose of this study was to evaluate the anterior/posterior (A/P) fatigue strength of the Journey II Articular Stabilized (AS) Insert as compared to the Journey II Bi-Cruciate Stabilized (BCS) Insert.
- . Tibiofemoral Constraint Testing According to ASTM F1223-20 of the Journey BCS Femoral in Conjunction with the Journey II Articular Stabilized (AS) Insert as Compared to the Journey II BCS Insert (OR-21-059) - The purpose of this study was to evaluate the anterior/posterior (A/P) draw constraint and flexion rotary laxity (R/L) torsional constraint for the Journey II Articular Stabilized (AS) insert as compared to the Journey II BCS insert.
- Tibiofemoral Contact Area Analysis of the Size 1 Journey II BCS Femoral ● Component on Size 1-2 Journey II Articular Stabilized (AS) Inserts from 0° to 160° of Angulation (OR-21-060) - The purpose of this study was to evaluate the tibiofemoral contact area of the Journey II BCS femoral component with the Journey II Articular Stabilized (AS) Inserts at Internal/External (I/E) rotation angles. These results were compared to the previously evaluated results of the tibiofemoral contact area of the Journey II BCS femoral with the Journey II BCS inserts.
- Tibiofemoral Contact Area Analysis of the Size 1 Journey II CR Femoral . Component on Size 1-2 Journey II Medial Dished (MD) Inserts from 0° to 160° Anqulation (OR-21-061) - The purpose of this study was to evaluate the tibiofemoral contact area of the Journey II CR femoral component with the Journey II Medial Dished (MD) Inserts at Internal/External (I/E) rotation angles. These results were compared to the previously evaluated results of the tibiofemoral contact area of the Journey II CR femoral with the Journey II CR Standard and Deep Dish Inserts.
- Tibiofemoral Constraint Testing of the Journey II CR Femoral in . Conjunction with the Journey II Medial Dished (MD) Insert (OR-21-062) -The purpose of this study was to evaluate the anterior/posterior (A/P) draw, medial/lateral (M/L) constraint, and rotary laxity (R/L) torsional constraint of flexion for the Journey II Medial Dished (MD) insert as compared to the Journey II CR insert and the Journey II Deep Dished insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111711, K140555, K121443, K113482
Reference Device(s)
Not Found
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
August 17, 2021
Image /page/0/Picture/1 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Kayla Franklin Regulatory Affairs Specialist I 1450 East Brooks Rd Memphis, Tennessee 38116
Re: K211671
Trade/Device Name: Journey II Mid-Level Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 6, 2021 Received: August 9, 2021
Dear Kayla Franklin:
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,
Ting Song, Ph.D., R.A.C. 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
2
Indications for Use
510(k) Number (if known)
Device Name Journey II Mid-Level Tibial Inserts Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use (Describe)
Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicoment, 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.
| FERENCE PERSONAL PROPERTY OF COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CO
| 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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510(k) Summary
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | August 17, 2021 |
| Contact Person: | Kayla Franklin, Regulatory Affairs Specialist I
T (901) 800-3398
M (901) 325-2471 |
| Name of Device: | Journey II Mid-Level Tibial Inserts |
| 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: | Orthopedics/87 |
| Product Code: | JWH |
| Predicate Device: | Journey II BCS XLPE Articular Inserts, Journey II BCS
Constrained Articular Inserts, Journey II CR XLPE
Articular Inserts, and Journey II Inserts XLPE Deep Dished |
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Device Description:
The purpose of this Special 510(k) is to notify FDA of our intent to market the Smith & Nephew Journey II Mid-Level Tibial Inserts. The Smith & Nephew Journey II Mid-Level Tibial Inserts consist of Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9mm-21mm) and Journey II Medial Dished XLPE Articular Inserts Size 1-8 Right and Left (9-18mm).
The Smith & Nephew Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9-21mm) are line additions to the existing Journey II BCS XLPE Articular Inserts Size 1-8 Right and Left (9-21mm) and the Journey II BCS Constrained Articular Inserts Size 1-8 Right and Left (9-25mm) cleared via premarket notification K111711 and K140555, respectively.
The Smith & Nephew Journey II Medial Dished XLPE Articular Insert Size 1-8 Right and Left 9-18mm are line additions to the existing Journey II CR XLPE Articular Insert Size 1-8 Right and Left (9-18mm) and the Journey II Insert XLPE Deep Dished Right and Left Size 1-8 (9-21mm) cleared via premarket notification K121443 and K113482, respectively.
The Journey II Articular Stabilized XLPE Articular Inserts offers total knee arthroplasty patients with soft tissue structures on the lateral side of the knee increased laxity an additional level of conformity to provide needed stability. The Journey II Articular Stabilized XLPE Articular Inserts provide additional posterolateral A/P stability compared to Journey II BCS but without the varus/valgus constraint provided by the more robust Journey II BCS Constrained post.
The Journey II Medial Dished XLPE Articular Inserts offers total knee arthroplasty patients having insufficient posterior cruciate ligament (PCL) function an additional level of medial anterior/posterior constraint over existing Journey II CR XLPE Articular Inserts while
5
seeking to promote improved kinematics and lateral femoral rollback compared to the more constraining Journey II Inserts XLPE Deep Dished.
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.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject devices, Journey II Mid-Level Tibial Inserts, are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, similar design, material and performance characteristics.
Substantial Equivalence Information
The overall design, materials, and indications for Journey II Mid-Level Tibial Inserts are substantially equivalent to the predicate devices listed in Table 6.1 below.
Table 6.1: Predicate Devices
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-------------------------|-------------------------------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew,
Inc. | Journey II BCS XLPE Articular
Inserts Size 1-8 Right and Left (9-
21mm) | K111711 | 09/16/2011 |
| Smith & Nephew,
Inc. | Journey II BCS Constrained
Articular Inserts Size 1-8 Right
and Left (9-25mm) | K140555 | 05/29/2014 |
| Smith & Nephew,
Inc. | Journey II CR XLPE Articular
Insert Size 1-8 Right and Left (9-
18mm) | K121443 | 08/13/2012 |
6
| Smith & Nephew,
Inc. | Journey II Insert XLPE Deep
Dished Right and Left Size 1-8
(9-21mm) | K113482 | 02/27/2012 |
| ------------------------- | --------------------------------------------------------------------------- | --------- | ------------ |
|---|
Preclinical Testing
To further support a determination of substantial equivalence, various types of preclinical testing were conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices described in Table 6.1 above. A review of the testing indicates that the Journey II Mid-Level Tibial Inserts are substantially equivalent to predicate devices listed in above. The specific types of pre-clinical testing include:
- Finite Element Analysis of the Post Strength of the Journey II Articular . Stabilized (AS) Insert as Compared to the Journey II Bi-Cruciate Stabilized (BCS) Insert (OR-20-140) - The primary goal of this study was to evaluate the structural strengths of the Journey II Articular Stabilized (AS) Insert Implants. Maximum principal stresses were calculated using Finite Element Analysis (FEA).
- Anterior/Posterior (A/P) 30° Fatigue Testing of the Journey II Articular . Stabilized (AS) Size 5-6 Tibial Insert (OR-21-058) – The purpose of this study was to evaluate the anterior/posterior (A/P) fatigue strength of the Journey II Articular Stabilized (AS) Insert as compared to the Journey II Bi-Cruciate Stabilized (BCS) Insert.
- . Tibiofemoral Constraint Testing According to ASTM F1223-20 of the Journey BCS Femoral in Conjunction with the Journey II Articular Stabilized (AS) Insert as Compared to the Journey II BCS Insert (OR-21-059) - The purpose of this study was to evaluate the anterior/posterior (A/P) draw constraint and flexion rotary laxity (R/L) torsional constraint for the
7
Journey II Articular Stabilized (AS) insert as compared to the Journey II BCS insert.
- Tibiofemoral Contact Area Analysis of the Size 1 Journey II BCS Femoral ● Component on Size 1-2 Journey II Articular Stabilized (AS) Inserts from 0° to 160° of Angulation (OR-21-060) - The purpose of this study was to evaluate the tibiofemoral contact area of the Journey II BCS femoral component with the Journey II Articular Stabilized (AS) Inserts at Internal/External (I/E) rotation angles. These results were compared to the previously evaluated results of the tibiofemoral contact area of the Journey II BCS femoral with the Journey II BCS inserts.
- Tibiofemoral Contact Area Analysis of the Size 1 Journey II CR Femoral . Component on Size 1-2 Journey II Medial Dished (MD) Inserts from 0° to 160° Anqulation (OR-21-061) - The purpose of this study was to evaluate the tibiofemoral contact area of the Journey II CR femoral component with the Journey II Medial Dished (MD) Inserts at Internal/External (I/E) rotation angles. These results were compared to the previously evaluated results of the tibiofemoral contact area of the Journey II CR femoral with the Journey II CR Standard and Deep Dish Inserts.
- Tibiofemoral Constraint Testing of the Journey II CR Femoral in . Conjunction with the Journey II Medial Dished (MD) Insert (OR-21-062) -The purpose of this study was to evaluate the anterior/posterior (A/P) draw, medial/lateral (M/L) constraint, and rotary laxity (R/L) torsional constraint of flexion for the Journey II Medial Dished (MD) insert as compared to the Journey II CR insert and the Journey II Deep Dished insert.
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Conclusion
In summary, this Special 510(k) Premarket Notification is being submitted to request clearance for the Journey II Mid-Level Tibial Inserts. Based on the similarities to the predicate devices, the subject devices are product derivatives and substantially equivalent to the commercially available predicate devices listed above.