(77 days)
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.
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 provided text describes a 510(k) premarket notification for a medical device called "Journey II Mid-Level Tibial Inserts." This submission aims to demonstrate that the new device is substantially equivalent to previously cleared predicate devices. Since this is a submission for substantial equivalence based on similar design, material, and performance characteristics compared to existing devices, it primarily relies on preclinical testing rather than clinical studies involving human patients, multi-reader multi-case (MRMC) comparative effectiveness studies, or extensive standalone algorithm performance evaluations.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the overall device in terms of specific performance metrics with numerical thresholds. Instead, the "acceptance criteria" are implied by demonstrating that the new device's performance in various preclinical tests is comparable to or within acceptable limits relative to existing predicate devices. The "reported device performance" is the outcome of these preclinical tests, showing that the subject device performs similarly to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Structural Integrity (Post Strength): Maximum principal stresses are comparable to predicate devices. | Finite Element Analysis (OR-20-140): Evaluated structural strengths; maximum principal stresses calculated using FEA. Implicitly, these were found to be acceptable relative to the Journey II Bi-Cruciate Stabilized (BCS) Insert. |
| Fatigue Strength (A/P 30°): Anterior/posterior fatigue strength is comparable to predicate devices. | Anterior/Posterior (A/P) 30° Fatigue Testing (OR-21-058): Evaluated A/P fatigue strength. Implicitly, the Journey II Articular Stabilized (AS) Insert was found comparable to the Journey II BCS Insert. |
| Tibiofemoral Constraint (A/P Draw, Flexion Rotary Laxity): Constraint characteristics are comparable to predicate devices (ASTM F1223-20). | Tibiofemoral Constraint Testing (OR-21-059): Evaluated A/P draw constraint and flexion rotary laxity (R/L) torsional constraint. Implicitly, the Journey II AS insert was found comparable to the Journey II BCS insert. |
| Tibiofemoral Contact Area (0°-160° Angulation): Contact area characteristics are comparable to predicate devices. | Tibiofemoral Contact Area Analysis (OR-21-060, OR-21-061): Evaluated tibiofemoral contact area at various angulations and rotation angles. - OR-21-060: Journey II BCS femoral component with Journey II AS Inserts compared to Journey II BCS inserts. - OR-21-061: Journey II CR femoral component with Journey II Medial Dished (MD) Inserts compared to Journey II CR Standard and Deep Dish Inserts. Implicitly, contact area characteristics were found to be comparable. |
| Tibiofemoral Constraint (A/P Draw, M/L Constraint, Rotary Laxity): Constraint characteristics are comparable to predicate devices. | Tibiofemoral Constraint Testing (OR-21-062): Evaluated A/P draw, medial/lateral (M/L) constraint, and rotary laxity (R/L) torsional constraint of flexion. Implicitly, the Journey II MD insert was found comparable to the Journey II CR insert and the Journey II Deep Dished insert. |
2. Sample Size Used for the Test Set and Data Provenance:
The studies described are preclinical tests, meaning they are conducted in a laboratory setting using physical devices, not human patients. Therefore, terms like "test set" in the context of human data, "country of origin," and "retrospective or prospective" do not directly apply here. The "sample size" would refer to the number of device samples tested for each study. While the specific number of units tested per study (e.g., how many AS Inserts were tested for fatigue) is not explicitly provided in this summary, the studies were conducted by Smith & Nephew, Inc. in the US, as indicated by the submission information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies are preclinical, bench-top tests, not clinical evaluations requiring expert consensus for ground truth. The "ground truth" in these studies is derived from physical measurements and accepted engineering standards (e.g., ASTM F1223-20).
4. Adjudication Method for the Test Set:
This is not applicable as the studies are preclinical tests, not clinical evaluations that typically involve adjudication of human reader findings.
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:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation of medical images. The device in question is a knee implant component, and the evaluations are preclinical performance tests.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical knee implant component, not an algorithm. The "standalone" performance here refers to the physical properties and mechanical performance of the implant itself, which is what the preclinical tests evaluated.
7. The Type of Ground Truth Used:
The ground truth used for these preclinical tests is based on engineering measurements, physical properties, and established industry standards (e.g., ASTM F1223-20 for tibiofemoral constraint testing). The performance of the subject device is compared to these standards or to the known performance of predicate devices.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical medical implant, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reason as point 8.
{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 COType 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
ﻧﻬ
{3}------------------------------------------------
510(k) Summary
| Submitted by: | Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Submission: | August 17, 2021 |
| Contact Person: | Kayla Franklin, Regulatory Affairs Specialist IT (901) 800-3398M (901) 325-2471 |
| Name of Device: | Journey II Mid-Level Tibial Inserts |
| 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: | Orthopedics/87 |
| Product Code: | JWH |
| Predicate Device: | Journey II BCS XLPE Articular Inserts, Journey II BCSConstrained Articular Inserts, Journey II CR XLPEArticular Inserts, and Journey II Inserts XLPE Deep Dished |
{4}------------------------------------------------
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 | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew,Inc. | Journey II BCS XLPE ArticularInserts Size 1-8 Right and Left (9-21mm) | K111711 | 09/16/2011 |
| Smith & Nephew,Inc. | Journey II BCS ConstrainedArticular Inserts Size 1-8 Rightand Left (9-25mm) | K140555 | 05/29/2014 |
| Smith & Nephew,Inc. | Journey II CR XLPE ArticularInsert Size 1-8 Right and Left (9-18mm) | K121443 | 08/13/2012 |
{6}------------------------------------------------
| Smith & Nephew,Inc. | Journey II Insert XLPE DeepDished 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.
{8}------------------------------------------------
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.
§ 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.