Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

The Smith & Nephew Legion CR Porous Plus HA Femoral components are indicated for use without bone cement and are single use devices.

Device Description

The subject of this Special 510(k) is to seek clearance for an additional hydroxyapatite (HA) coating supplier for Smith & Nephew's LEGION CR Porous Plus HA Femoral Components. The LEGION Porous Plus HA Primary Femoral Components were previously cleared for market via premarket notification K091543 (S.E. 12/21/2009). The subject device is used in total knee arthroplasty procedures and is available in sizes 2-8 in both left and right configurations. Like the predicate LEGION Porous Plus HA Primary Femoral Components, the subject device is manufactured from cast cobalt-chrome-molybdenum alloy (ASTM F75) with a cobalt-chromemolybdenum (ASTM F75) sintered bead porous coating (ROUGHCOAT). Additionally, the LEGION CR Porous Plus HA Femoral Components are coated with a thin layer of plasmasprayed hydroxyapatite (HA). There has been no change in femoral size, substrate material, porous coating, or device design as a result of this submission.

The only modification of the previously cleared LEGION CR Porous Plus HA Femoral Components is the addition of an alternate supplier to administer the HA coating process. The device design, principle of operation, substrate material, dimensional characteristics, and indications for use for the subject device will not change as a result of the implementation of an alternate HA coating supplier.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the LEGION CR Porous Plus HA Femoral Components. The primary change being cleared is the addition of an alternate supplier for the hydroxyapatite (HA) coating, with no changes to the device's design, materials, or indications for use.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance (with new HA supplier)
Coating Properties (General)	HA coating characteristics meet or exceed applicable FDA Guidance and ISO Standards.	The new HA coating characteristics meet or exceed the applicable FDA Guidance and ISO Standards.
Fatigue Performance	Dual-layer coating (ROUGHCOAT and HA) with the new HA coating supplier performs equivalently to the predicate device.	Fatigue testing demonstrated that the coating properties, via the subject alternate supplier, perform equivalent to the predicate LEGION Porous Plus HA Primary Femoral Components (K091543).
Safety and Effectiveness Risks	No new risks related to the safety and effectiveness as a result of the alternate HA coating supplier.	A review of testing has demonstrated that there are no new risks related to the safety and effectiveness of the subject device with the HA coating process performed by the subject alternate HA coating supplier.
Substantial Equivalence	Device remains substantially equivalent to the predicate device in terms of intended use, indications for use, design, materials, performance characteristics, and operational principles.	The device is identical in function, design features, intended use, indications for use, operational principles, manufacturing processes, and similar in materials as the commercially available predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the document. The text refers to "non-clinical fatigue testing" and "coating characterization" without specifying the number of samples or implants tested for these evaluations.
Data Provenance: The testing was conducted by Smith & Nephew, the manufacturer. The document doesn't specify the country of origin of the data beyond that it was performed internally. It's retrospective in the sense that it's comparing the performance of the modified device to a previously cleared predicate and its existing data. It's a lab-based, pre-market evaluation rather than a clinical study on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission relies on non-clinical, mechanical, and material characteristic testing. The "ground truth" is established by adherence to engineering standards (FDA Guidance, ISO Standards) and direct comparative performance against the predicate device in a laboratory setting. There were no human experts establishing ground truth in the context of clinical interpretation or diagnosis for this specific clearance.

4. Adjudication method for the test set:

Not applicable. This information is relevant for studies involving human interpretation (e.g., radiologists reviewing images). Since this is a non-clinical, laboratory-based performance study, adjudication methods for expert consensus are not relevant. The assessment is based on objective measurements and comparison to established benchmarks and predicate device performance.

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 or assistive devices involving human interpretation. This submission is for a knee implant component, and its clearance is based on non-clinical performance data.

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

Not applicable. This question pertains to AI/algorithm performance. This device is a passive implant component, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is based on:
- Engineering and Material Standards: Adherence to applicable FDA Guidance and ISO Standards for HA coating characteristics.
- Predicate Device Performance: Direct comparison of the fatigue and coating properties of the device (with the new HA supplier) to the established performance of the legally marketed predicate device (LEGION Porous Plus HA Primary Femoral Components – K091543).
- Objective Measurements: Results from non-clinical fatigue testing and precise HA coating characterizations (static shear, shear fatigue, and HA powder values).

8. The sample size for the training set:

Not applicable. This question applies to machine learning models that require a training set. This submission is for a medical device component, not an AI/ML product.

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

Not applicable. As stated above, there is no training set for this device.

Summary

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May 24, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K211246

Trade/Device Name: LEGION CR Porous Plus HA Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: April 23, 2021 Received: April 26, 2021

Dear Leah Hawkins:

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., 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

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Indications for Use

510(k) Number (if known) K211246

Device Name

LEGION CR Porous Plus HA Femoral Components

Indications for Use (Describe)

Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

The Smith & Nephew Legion CR Porous Plus HA Femoral components are indicated for use without bone cement and are single use devices.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Smith & Nephew – LEGION CR Porous Plus HA Femoral Components

510(k)Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Submission:	April 23, 2021
Contact Person:	Leah Hawkins, Regulatory Affairs SpecialistT (901) 800-3355M (901) 463-8447Additional Contact:Michelle Huettner, Director of Regulatory AffairsT (901) 800-3241M (765) 426-6070
Name of Device:	LEGION CR Porous Plus HA FemoralComponents
Common Name:	Femoral Knee Prosthesis
Device Classification Name andReference:	21 CFR 888.3565 - Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	MBH - Prosthesis, Knee, Patello/Femorotibial,Semi-Constrained, Uncemented, Porous, Coated,Polymer/Metal/Polymer
Predicate Device:	LEGION Porous Plus HA Primary FemoralComponents – K091543 (S.E. 12/21/2009)

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510(k) SUMMARY Smith & Nephew - LEGION CR Porous Plus HA Femoral Components

Device Description

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.

The Smith & Nephew Legion CR Porous Plus HA Femoral components are indicated for use without bone cement and are single use devices.

Technological Characteristics

The HA coating process from the previous supplier to the subject alternate supplier remains unchanged and the new HA coating characteristics meet or exceed the applicable FDA Guidance and ISO Standards. Device comparisons and non-clinical testing show that the subject device LEGION CR Porous Plus HA Femoral Components are substantially equivalent

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510(k) SUMMARY Smith & Nephew - LEGION CR Porous Plus HA Femoral Components

to the predicate LEGION Porous Plus HA Primary Femoral Components (K091543) in terms of intended use, indications for use, design, materials, performance characteristics, and operational principles.

Substantial Equivalence Information

The Smith & Nephew LEGION CR Porous Plus HA Femoral Components are identical in function, design features, intended use, indications for use, operational principles, manufacturing processes, and similar in materials as the commercially available predicate devices listed below in Table 6.1.

Table 6.1: Predicate Device

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	LEGION Porous PlusHA Primary FemoralComponent	K091543	12/21/2009

Performance Testing

Smith & Nephew conducted non-clinical fatigue testing of the dual-layer coating (ROUGHCOAT and HA) with the HA coating applied by the subject alternate supplier. The results of this testing demonstrated that the coating properties, via subject alternate supplier, perform equivalent to the predicate LEGION Porous Plus HA Primary Femoral Components (K091543).

Fatigue testing and coating characterization was completed in line with FDA's guidance document entitled, "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants," dated March 10, 1995 (revised 2/20/1997). A review of this testing has demonstrated that there are no new risks related to the safety and effectiveness of the subject device with HA coating process performed by the subject alternate HA coating supplier. Precise HA coating characterizations (static shear, shear fatigue, and HA powder values) are discussed in detail in the supplier's Master File.

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510(k) SUMMARY Smith & Nephew - LEGION CR Porous Plus HA Femoral Components

Based on the testing within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device.

Conclusion

As previously noted, this Special 510(k) Premarket Notification is to seek clearance of the addition of alternate hydroxyapatite (HA) coating supplier for the LEGION CR Porous Plus HA Femoral Components. Based on the similarities to the predicate device and HA coating testing justifications, there are no new risks related to the safety and effectiveness and the subject device is substantially equivalent to the commercially available cleared predicate device.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.