Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, 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 Legion Inserts with JRNY Lock are single use devices.

Device Description

The subject of this Special 510(k) is the LEGION Inserts with JRNY Lock (LEGION Inserts). The subject LEGION Inserts are tibia insert components, and a line extension of the LEGION CR High Flex and Deep Dish inserts cleared under premarket notification K071071. The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the JOURNEY II CR and JOURNEY II BCS inserts, cleared under premarket notifications K121443 and K111711 respectively.

The subject LEGION Inserts have a size range of 1-2, 3-4, 5-6, 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21mm, and come in cruciate-retaining high flexion (CR HF) and Deep Dish varieties. The LEGION Inserts are manufactured from 7.5MRad Cross-linked Polyethylene (XLPE) conforming to ASTM F648 and ISO 5834-2, as the predicate LEGION CR Inserts cleared under a premarket notification K071071.

AI/ML Overview

This document describes a 510(k) premarket notification for LEGION Inserts with JRNY Lock, which are tibial insert components for total knee replacement. The submission argues for substantial equivalence to existing predicate devices based on technological characteristics and mechanical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance testing section mentions the types of tests performed and concludes that the subject device is "substantially equivalent" to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Equivalent to predicate devices in:	- Range of Motion and Constraint: Performed
- Range of Motion and Constraint	- Tibiofemoral Contact Area Analysis: Performed
- Tibiofemoral Contact Area Analysis	- Component Interlock Strength Testing: Performed
- Component Interlock Strength Testing	- Substantially equivalent to predicate devices based on leveraged non-clinical bench (mechanical) testing.
Biocompatibility/Sterility: Meet acceptable endotoxin limits.	- Bacterial endotoxin testing: Completed and met acceptable endotoxin limits as stated in FDA guidance and ANSI/AAMI ST72.
Function, Intended Use, Indications for Use, Material Composition, Overall Design: Identical/very similar to predicate devices.	- Identical in function, intended use, indications for use, and material composition.- Very similar in overall design.
No new issues related to safety and effectiveness.	- No new issues related to the safety and effectiveness of the subject devices demonstrated by review of technological characteristics and testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "leveraged non-clinical bench (mechanical) testing." This indicates the use of physical samples or models for mechanical tests, not human data. The specific sample size for each test (e.g., number of inserts tested for range of motion) is not specified.
There is no information about the country of origin of the data as it's non-clinical bench testing, and it's not applicable to human data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study is non-clinical bench testing of a medical device (knee inserts) and does not involve establishing ground truth from expert readings of patient data. The "ground truth" for these tests would be the design specifications and performance characteristics of the predicate devices and relevant industry standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study is non-clinical bench testing. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical data to resolve discrepancies.

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 submission is for a knee implant component and relies on non-clinical mechanical testing and comparison to predicate devices, not AI assistance or human reader evaluations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This is not an AI-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

Established performance of predicate devices: The comparison standard for substantial equivalence.
Industry Standards: ASTM F648 and ISO 5834-2 for material properties (XLPE), and FDA Guidance/ANSI/AAMI ST72 for bacterial endotoxin testing.
Design Specifications: The documented design and intended function of both the subject device and the predicate devices.

8. The sample size for the training set

Not applicable. This submission is not for an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. (See point 8).

Summary

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March 13, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Smith & Nephew, Inc. Konrad Wolfmeyer Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K200407

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: February 17, 2020 Received: February 19, 2020

Dear Konrad Wolfmeyer:

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 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) K200407

Device Name LEGION Inserts with JRNY Lock

Indications for Use (Describe)

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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Smith Nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	March 11, 2020
Contact Person and Address:	Konrad WolfmeyerRegulatory Affairs SpecialistPhone: (901) 399-1367
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 prosthesis
	21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis.
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH, MBH
Predicate Device:	Primary Predicate - K071071 - CrosslinkedPolyethylene Articular InsertsPredicate - K121443 – JOURNEY II CR KneeSystemPredicate - K111711 – JOURNEY II BCS KneeSystem

Device Description

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Smith Nephew

(XLPE) conforming to ASTM F648 and ISO 5834-2, as the predicate LEGION CR Inserts cleared under a premarket notification K071071.

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.

The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.

Technological Characteristics

A review of the technological characteristics indicates that the 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. Clinical data was not needed to support 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 identical in function, intended use, indications for use, and material composition, and very similar in overall design to the predicate devices listed in the following table.

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Crosslinked PolyethyleneArticular Inserts (LEGION)	K071071	9/19/2007
Smith & Nephew,Inc.	JOURNEY II CR KneeSystem	K121443	8/13/2012
Smith & Nephew,Inc.	JOURNEY II BCS KneeSystem	K111711	9/16/2011

Table 5.1: Substantially Equivalent Predicates

Performance Testing:

To further support a determination of substantial equivalence, leveraged non-clinical bench (mechanical) testing was utilized. A review of the leveraged mechanical data indicates that the subject LEGION Inserts are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The following performance testing were used as a basis for the determination of substantial equivalence.

. Range of Motion and Constraint

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Smith Nephew

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.

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, the devices are substantially equivalent to the commercially available predicate devices listed above.

Regulation Number and Section

§ 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.