Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.

Device Description

Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants. The subject devices will be initially offered in both cruciate retaining (CR) and posterior stabilizing (PS) designs in sizes 1-8 in right and left hand configurations. The subject devices will utilize the same articular inserts as the non-HA coated Legion Porous Primary femoral components cleared via K073325 and will use existing Genesis II tibial baseplate and patellar components cleared via K030612.

AI/ML Overview

This 510(k) premarket notification for the LEGION Porous Plus HA Primary Femoral Components does not present a study proving the device meets specific acceptance criteria in the way a clinical study for diagnostic accuracy would.

Instead, this submission establishes substantial equivalence to previously cleared predicate devices through a comparison of design, indications, and mechanical testing. The acceptance criteria here are related to demonstrating this equivalence, rather than a quantifiable performance metric for a new claim.

Here's a breakdown of the requested information based on the provided document, noting where information is not applicable due to the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Comparison	Reported Device Performance
Mechanical Equivalence	Withstand expected in vivo loading without failure.	"A review of the mechanical testing results indicated that the Legion Porous Plus HA Primary Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Geometric Equivalence	Geometrically identical to Legion Porous Primary femoral components (K073325).	"Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325."
Indications for Use Equivalence	Similar indications to predicate device.	"The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are similar in overall design, indications, and materials to the Legion Porous Primary femoral components cleared via K073325." (Indications for use are listed explicitly and are consistent with predicate devices).
HA Coating Equivalence	Same HA coating as devices in Genesis II Porous Plus HA Knee System (K032683).	"The subject devices feature the same HA coating as devices in the Genesis II Porous Plus HA Knee System cleared via K032683."
Material Equivalence	Similar materials to predicate device.	"The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are similar in overall design, indications, and materials to the Legion Porous Primary femoral components cleared via K073325."

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

Not applicable in the context of a clinical test set. The provided document describes mechanical testing and a comparison to predicate devices, not a clinical study with a test set of patient data. The "test set" here would refer to the samples of the device undergoing mechanical evaluation. The document does not specify the number of samples used for mechanical testing. Data provenance is not specified.

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)

Not applicable. This submission relies on engineering and regulatory review (mechanical testing, equivalence to predicate device specifications), not expert clinical adjudication of a test set for diagnostic performance.

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

Not applicable. See point 3.

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. This is not a diagnostic AI device.

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

No. This is not an algorithm or AI device.

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

The "ground truth" in this context is established by:
- Mechanical Engineering Standards: The ability of the device to withstand expected in vivo loading, demonstrated through standard mechanical tests.
- Predicate Device Specifications: The established design, indications, materials, and HA coating of previously cleared devices (K073325 and K032683).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

Summary of the Study/Evidence:

The "study" in this 510(k) is primarily a comparison of the new device (Legion Porous Plus HA Primary Femoral Components) to legally marketed predicate devices and verification through mechanical testing. The core argument is manufactured equivalence and performance consistency with devices already on the market.

The key "evidence" presented is:

Geometric identity to the Legion Porous Primary femoral components (K073325).
Use of the same HA coating as devices in the Genesis II Porous Plus HA Knee System (K032683).
Mechanical testing results showing the device is capable of withstanding expected in vivo loading without failure, indicating equivalence to clinically used devices.
Similar overall design, indications, and materials to the predicate device.

This approach is typical for 510(k) submissions where a new device is very similar to an already cleared one, with minor modifications (in this case, the addition of an HA coating to an existing femoral component design). The "acceptance criteria" are met by demonstrating this substantial equivalence.

Summary

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K091543

510(k) Summary of Safety and Effectiveness LEGION® Porous Plus HA Primary Femoral Components

Date of Summary: May 22, 2009

Contact Person and Address Jason Sells Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-5520

DEC 2 1 2009

Name of Device: Smith & Nephew Legion Porous Plus HA Primary Femoral Components Common Name: Femoral Knee Prosthesis

Device Classification Name and Reference: 21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (Class II)

Device Product Code: MBH

Device Description

Mechanical Testing

A review of the mechanical testing results indicated that the Legion Porous Plus HA Primary Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative anthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.

Substantial Equivalence Information

The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are similar in overall design, indications, and materials to the Legion Porous Primary femoral components cleared via K073325. The subject devices feature the same HA coating as devices in the Genesis II Porous Plus HA Knee System cleared via K032683.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human welfare. The logo is simple and recognizable, often used in official documents and communications related to the department.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Mr. Jason Sells Orthopaedic Division 1450 E Brooks Road Memphis, Tennessee 38116

DEC 2 1 2009

Re: K091543

Trade/Device Name: Legion Porous Plus HA Primary 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: December 8, 2009 Received: December 9, 2009

Dear Mr. Sells:

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. 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.

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

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Page 2 - Mr. Jason Sells

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dgfault.htm.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: LEGION Porous Plus HA Primary Femoral Components

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091543

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.