Rheumatoid arthritis
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
The posterior-stabilized knee system is 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 Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

Device Description

Subject of this premarket notification is a review of changes to the Profix Porous Tibial Baseplates (previously cleared for market via premarket notification K030623) to result in the Legion Porous + HA Tibial Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti-6Al-4V material and feature a porous coating of CP Ti beads and an HA coating. The devices will be available in left and right configurations in sizes 2 through 8.
When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:

Utilization of the Genesis II style periphery, profile, and locking detail
Addition of HA coating
Increase in thickness of baseplate

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Legion Porous + HA Tibial Baseplates." This regulatory document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against specific acceptance criteria in the way one might see for a novel AI device or a new drug.

Therefore, many of the requested categories regarding acceptance criteria, study design, expert involvement, and training/test sets for AI/algorithms are not applicable to this type of medical device submission. The submission relies on design verification testing to demonstrate that modifications do not introduce new safety or effectiveness issues, in comparison to the predicates.

Here's a breakdown of the available information based on your request, with an emphasis on what is not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated in terms of pass/fail numbers)	Reported Device Performance (Summary)
Safety and Effectiveness (as per FDA guidance)	Design verification testing demonstrated "no new issues related to the safety or effectiveness of the subject devices."
Functional equivalence to predicate devices	"Substantially equivalent" to predicate devices (K030623, K032683).

Note: The FDA's 510(k) process for devices like this typically doesn't define quantitative "acceptance criteria" in the same way an AI performance study would. Instead, it relies on demonstrating that design changes do not adversely affect safety and effectiveness compared to predicate devices, often through mechanical testing and comparison of materials and intended use. The "performance" here is primarily about functional equivalence and mechanical integrity, not statistical clinical outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable in the traditional sense of a clinical test set. The "testing" appears to be mechanical design verification, which uses physical samples of the device components. The document doesn't specify the number of physical samples, but it's not a "test set" of patient data.
Data Provenance: Not applicable for patient data. The "data" comes from engineering and mechanical testing of the physical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. There is no "ground truth" in the clinical data sense for this type of submission. The evaluation is based on engineering principles and regulatory guidelines.

4. Adjudication Method for the Test Set:

Not Applicable. There's no clinical adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an MRMC study. These studies are typically for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated. This submission is for an orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

Not Applicable in the clinical sense. The "truth" in this context is adherence to engineering specifications, material properties, and mechanical performance standards (e.g., fatigue strength, fixation strength) as outlined in FDA guidance documents for knee implants. There's no pathology, expert consensus on images, or outcomes data used to establish "ground truth" for the device's basic function in this submission.

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.

Summary of the Study/Evaluation:

The submission for the Legion Porous + HA Tibial Baseplates is a 510(k) premarket notification, specifically a "Special 510(k)" which indicates minor changes to a previously cleared device. The "study" proving the device meets criteria is primarily design verification testing and a comparison to predicate devices.

Purpose: To demonstrate that the modified device (Legion Porous + HA Tibial Baseplates) is substantially equivalent to legally marketed predicate devices (Profix Total Knee System K030623 and Genesis II Porous + HA Knee System K032683).
Methodology:
- Design Verification Testing: Performed based on FDA guidance documents for knee joint prostheses and modular implant components. This type of testing typically involves mechanical bench tests (e.g., fatigue, static strength, wear) to ensure the device meets engineering specifications and regulatory standards. The document states this testing "demonstrated that there are no new issues related to the safety or effectiveness."
- Substantial Equivalence Argument: The submission argues that despite modifications (Genesis II style periphery, HA coating, increased thickness), the "overall design philosophy, intended use, and material choices" remain unchanged compared to the predicate devices.
Clinical Data: Explicitly stated as "not needed to support the safety and effectiveness of the subject device," reinforcing that the evaluation relied on non-clinical (mechanical) testing and comparison.

In essence, the "study" is a regulatory submission demonstrating mechanical integrity and equivalence, not a clinical trial or an AI performance study with patient data.

Summary

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K(∞89 7

Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.

Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340

Date of Summary: April 14, 2010

MAY 1 3 2010

Name of Device: Legion Porous + HA Tibial Baseplate Common Name: Total Knee Prosthesis Device Classification Name and Reference: 21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Device Class: Class II Panel Code: Orthopaedics/87 MBH

Device Description

When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:

0 Utilization of the Genesis II style periphery, profile, and locking detail
. Addition of HA coating
트 Increase in thickness of baseplate

Intended Use

Total knee components are indicated for:

1. Rheumatoid arthritis
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
এ. The posterior-stabilized knee system is 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 Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

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Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.

Performance Data

Design verification testing has been performed based on requirements outlined in FDA's Class 2 Special Controls Guidance Document Knee Joint Patellofemoratibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and Staff, dated January 16, 2003 and Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components dated May 1, 1995. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.

Clinical data was not needed to support the safety and effectiveness of the subject device.

Substantial Equivalence Information

The Legion Porous + HA Tibial Baseplates are substantially equivalent to previously cleared devices listed below. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate knee systems.

Description	510(k)	Clearance Date
Profix Total Knee System	K030623	5/22/03
Genesis II Porous + HA Knee System	K032683	10/15/03

Table 1. Predicate knee systems

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Legion Porous + HA Tibial Baseplates. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K030623 and K032683.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Orthopaedic Division Ms. Megan Bevill Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116

MAY 1 3 2010

Re: K100897

Trade/Device Name: Legion Porous + HA Tibial Baseplates Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: April 14, 2010 Received: April 15, 2010

Dear Ms. Bevill:

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. 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

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Page 2 - Ms. Megan Bevill

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/default.htm.

Sincerely yours,

Barbara Buechner

Mark N. Melke 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 + HA Tibial Baseplate

Total knee components are indicated for:

ﺒﺴﺘ Rheumatoid arthritis
1. Post-traumatic arthrilis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
The posterior-stabilized knee system is designed for use in patients in primary and revision 4. surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart Cl

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omitted for nxm
(Claim Signed)

Division of Surgical and Restorative Devices

510(k) Number K100897

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.