(29 days)
Total Knee components are indicated for rheumatoid 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 cruciate ligaments are incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.
The subject devices of this Special 510(k) are the LEGION Inserts with JRNY Lock. The subject LEGION Inserts with JRNY Lock are tibia insert components, and a line extension of the LEGION Articular Inserts cleared under premarket notification K071071 (S.E. 09/16/2007). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the LEGION CR High Flex and CR Deep Dish Inserts with JRNY Lock, cleared under premarket notifications K200407 (S.E. 3/13/2020) respectively.
The subject LEGION Inserts with JRNY Lock have a size range of 1-2, 3-4, 5-6, 7-8 with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21, 25, 30mm, and come in cruciate-retaining standard (CR STD), posterior-stabilizing standard (PS STD), posterior-stabilizing high flexion (PS HF) and posterior-stabilizing Constrained (PS Constrained) varieties.
The subject LEGION PS Constrained, LEGION PS STD, and LEGION CR STD Inserts with JRNY Lock are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE) and the subject LEGION PS HF Inserts with JRNY Lock are manufactured from 7.5MRad Crosslinked Polyethylene (XLPE) conforming to ASTM F648 (FDA Recognition Number 8-569) and ISO 5834-2 (FDA Recognition Number 8-514).
This FDA 510(k) premarket notification describes a medical device, specifically knee joint components (LEGION Inserts with JRNY Lock), and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance is not applicable to this document.
This document outlines the regulatory pathway for a conventional medical device modification, demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing and a review of technological characteristics, rather than AI/ML algorithm performance.
Therefore, many of the requested fields for AI/ML performance evaluation are not present or relevant in the provided text. I will address the relevant sections based on the information available and indicate where information is not applicable.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document describes a Special 510(k) submission for a modified medical device, the LEGION Inserts with JRNY Lock. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical performance and a review of technological characteristics, rather than the performance metrics of an AI/ML algorithm.
The "study that proves the device meets the acceptance criteria" for this conventional device involves performance testing to show that the modified device's mechanical characteristics are equivalent to the predicate devices and that the modification does not raise new safety or effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical device, not an AI/ML algorithm, the acceptance criteria are not in the form of sensitivity, specificity, or AUC. Instead, they relate to mechanical properties. The document states a "review of the leveraged mechanical data indicates that the subject LEGION Inserts with JRNY Lock are substantially equivalent to one or more of the previously cleared predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Subject devices are substantially equivalent to predicate devices based on a review of leveraged mechanical data. No new issues related to safety and effectiveness identified. |
| Range of Motion and Constraint | Reviewed and found to be substantially equivalent to predicate devices. |
| Tibiofemoral Contact Area Analysis | Reviewed and found to be substantially equivalent to predicate devices. |
| Component Interlock Strength Testing | Reviewed and found to be substantially equivalent to predicate devices. |
| Bacterial Endotoxin | Testing completed and met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically. The "test set" refers to the specific LEGION Inserts with JRNY Lock samples that underwent mechanical and endotoxin testing. This would typically involve a statistically relevant number of samples for each test, but the exact count is not detailed in the summary.
- Data Provenance: The document implies the data was generated internally by Smith & Nephew, Inc. as part of their premarket notification. This would be prospective data generation for the purpose of regulatory submission. The country of origin for the testing itself is not specified but is presumably conducted at facilities associated with the submitter, Smith & Nephew, Inc. (Cordova, Tennessee, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For a mechanical device, "ground truth" established by experts in the context of test set labeling (e.g., radiologists for images) is not relevant. The "ground truth" for mechanical testing would be defined by established engineering standards and physical measurements. The evaluation of test results would be conducted by qualified engineers and scientists.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data, which is not relevant for mechanical performance testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is for evaluating human performance with and without AI assistance, which is not relevant for this mechanical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This device is a physical knee implant component, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Standards and Physical Measurements: For mechanical performance tests (Range of Motion, Constraint, Tibiofemoral Contact Area Analysis, Component Interlock Strength Testing), the "ground truth" is based on established engineering principles, material properties, and relevant ASTM/ISO standards. For bacterial endotoxin testing, the "ground truth" is defined by the acceptable limits set in FDA guidance and ANSI/AAMI ST72.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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April 26, 2022
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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Madison Padgett Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K220896
Trade/Device Name: Legion Inserts with JRNY Lock Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: March 25, 2022 Received: March 28, 2022
Dear Madison Padgett:
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
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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. 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) K220896
Device Name LEGION Inserts with JRNY Lock
Total Knee components are indicated for theumatoid 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 cruciate ligaments are incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Summary Submitted by: | Smith & Nephew, Inc.Orthopaedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Summary: | March 25, 2022 |
| Primary Contact Person: | Madison Padgett, Regulatory Affairs Specialist IIPhone: (901) 456-8789 |
| Secondary Contact Person | Michelle Huettner, Director, Regulatory AffairsPhone: (765) 426-6070 |
| Name of Device: | LEGION Inserts with JRNY Lock |
| Common Name: | Tibial Articular Insert Components |
| Device Classification Name andReference: | 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprothesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerMBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
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Predicate Device:
Primary Predicate – K071071 – Crosslinked Polyethylene Articular Inserts (S.E. 9/19/2007) JWH, MBH Secondary Predicate – K962137 – GENESIS II Constrained System (S.E. 8/2/1996) JWH Reference Predicate – K200407 – LEGION Inserts with JRNY Lock (S.E. 3/13/2020) JWH
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Device Description
The subject devices of this Special 510(k) are the LEGION Inserts with JRNY Lock. The subject LEGION Inserts with JRNY Lock are tibia insert components, and a line extension of the LEGION Articular Inserts cleared under premarket notification K071071 (S.E. 09/16/2007). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the LEGION CR High Flex and CR Deep Dish Inserts with JRNY Lock, cleared under premarket notifications K200407 (S.E. 3/13/2020) respectively.
The subject LEGION Inserts with JRNY Lock have a size range of 1-2, 3-4, 5-6, 7-8 with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21, 25, 30mm, and come in cruciate-retaining standard (CR STD), posterior-stabilizing standard (PS STD), posterior-stabilizing high flexion (PS HF) and posterior-stabilizing Constrained (PS Constrained) varieties.
The subject LEGION PS Constrained, LEGION PS STD, and LEGION CR STD Inserts with JRNY Lock are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE) and the subject LEGION PS HF Inserts with JRNY Lock are manufactured from 7.5MRad Crosslinked Polyethylene (XLPE) conforming to ASTM F648 (FDA Recognition Number 8-569) and ISO 5834-2 (FDA Recognition Number 8-514).
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. 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are incompetent.
The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.
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Technological Characteristics
The subject devices were modified by incorporating the identical locking mechanism cleared under premarket notification K200407 (S.E. 03/13/2020) to the primary predicate LEGION Articular Inserts cleared under K071071 (S.E. 09/16/2007). A review of the technological characteristics indicates that the subject LEGION Inserts with JRNY Lock are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. 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.
Substantial Equivalence Information
The subject devices are substantially equivalent to the predicate devices listed in the following table in function, intended use, indications for use, design, and material composition.
| Manufacturer | Submission Name | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew,Inc. | Crosslinked PolyethyleneArticular Inserts (LEGION) | K071071 | 09/16/2007 |
| Smith & Nephew,Inc. | GENESIS II ConstrainedSystem | K962137 | 08/02/1996 |
| Smith & Nephew,Inc. | LEGION Inserts withJRNY Lock | K200407 | 03/13/2020 |
Table 5.1: Substantially Equivalent Predicates
Performance Testing:
A review of the leveraged mechanical data indicates that the subject LEGION Inserts with JRNY Lock are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The following characteristics and performance testing were reviewed to determine the substantial equivalence.
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- . Range of Motion and Constraint
- . Tibiofemoral Contact Area Analysis
- Component Interlock Strength Testing .
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72 (FDA Recognition Number 14-541).
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the LEGION Inserts with JRNY Lock. Based on the similarities to the predicate devices and rationale to support substantial equivalence, the subject devices are substantially equivalent to the commercially available predicate devices listed in Table 5.1.
§ 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.