Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
Inflammatory degenerative joint disease including rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Porous-coated total knee replacement components are for use without bone cement.

Device Description

The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:

All-poly patellae manufactured from UHMWPE
Available in sizes 25-41, single- or tri-peg design
Metal-backed patellae manufactured from UHMWPE and CoCr alloy
Available in sizes 29-38, tri-peg design with porous coating

AI/ML Overview

The provided document is a 510(k) Summary for the ADVANCE® Total Knee System, specifically for the addition of new patellar components. It outlines the device's indications for use, description, and claims of substantial equivalence to predicate devices. However, this type of regulatory submission does not typically include detailed acceptance criteria or a dedicated study report with performance metrics in the way a clinical trial or algorithm validation study would.

Here's an analysis based on the information provided, and where the requested details are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the evaluation of the new patellar components through "mechanical testing and engineering analyses." It states a general conclusion rather than specific numerical acceptance criteria and performance data.

Acceptance Criteria (Inferred)	Reported Device Performance
Capable of withstanding expected in vivo loading without failure	"A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure."
Mechanical (static stability, contact area, interface strength) and porous coating characteristics comparable to predicate devices	"The design features and materials of the subject devices are identical to those of the predicate devices."

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

This information is not provided in the 510(k) summary. The evaluation described involves "mechanical testing and engineering analyses" on the device itself, not a test set of patient data.

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

This is not applicable/not provided as the evaluation is based on mechanical testing and engineering analysis of the device, not a human reader assessment of medical imagery or patient outcomes.

4. Adjudication Method for the Test Set:

This is not applicable/not provided for the same reasons as above.

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

This is not applicable/not provided. The document describes mechanical testing of device components, not a study involving human readers or AI assistance.

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

This is not applicable/not provided. This document pertains to a physical medical device (knee implant components), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the results of standardized mechanical and engineering tests, as well as material characterization, demonstrating that the new patellar components perform equivalently to existing predicate devices and can withstand in vivo conditions. This is a physical/material ground truth, not a clinical one.

8. The Sample Size for the Training Set:

This is not applicable/not provided. There is no "training set" in the context of mechanical device testing.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable/not provided for the same reasons as above.

Summary of Study (Based on Provided Text):

The "study" described in the 510(k) summary is a mechanical and engineering evaluation of new patellar components for the ADVANCE® Total Knee System.

Objective: To demonstrate that the new patellar components (all-poly and metal-backed) are substantially equivalent to existing predicate devices and are safe and effective for their intended use.
Methodology:
- Mechanical Testing: Performed on the new patellar components to evaluate:
  - Static stability
  - Contact area
  - Interface strength
- Engineering Analyses: Used to interpret the mechanical testing results and compare them to performance expectations.
- Material Characterization: Fully characterized the porous coating for the metal-backed design and tested its static shear properties.
- Comparison to Predicate Devices: The results of these tests and analyses were used to establish "equivalence" with the design features and materials of the predicate devices (ADVANCE® Total Knee System, AXIOM® Total Knee System).
Conclusion: The review of these results indicated that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

Key Missing Information (for the requested table structure):

As this is a 510(k) Summary for a physical orthopedic implant, the provided document focuses on demonstrating substantial equivalence through mechanical and material characterization, rather than clinical performance data, AI algorithm validation, or human reader studies. Therefore, many categories in your requested table are not directly applicable or are not detailed in this type of submission. Specific numerical values for the mechanical tests (e.g., specific load tolerances, displacement limits, wear rates) would typically be found in a more detailed test report, but are summarized in the 510(k) for regulatory review.

Summary

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K122218
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 2 1 2013

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® Total Knee System.

Submitted By:

Date:

Contact Person:

Danielle Mueller Project Manager

February 19, 2013

(800) 238-7188

Proprietary Name:

Common Name:

Classification Name and Reference:

Project manager.

Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002

ADVANCE® Total Knee System

Patella

21 CFR 888.3560 Knee joint Patellofemorotibial Polymer / Metal / Polymer Semi-Constrained Cemented Prosthesis Class II

21 CFR 888.3565 Knee joint Patellofemorotibial Metal / Polymer Porous-Coated Uncemented Prosthesis Class II

Subject Product Code and Panel Code:

Predicate Devices:

Orthopedics/87/JWH, MBH

ADVANCE® Total Knee System AXIOM® Total Knee System 510(k)s: K953439, K061223, K894334

DEVICE INFORMATION

A. Intended Use

The ADVANCE® Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
1. Correction of functional deformity;
Revision procedures where other treatments or devices have failed; and treatment of fractures 4. that are unmanageable using other techniques.

Porous-coated total knee replacement components are for use without bone cement.

B. Device Description

The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:

. All-poly patellae manufactured from UHMWPE
- . Available in sizes 25-41, single- or tri-peg design

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Metal-backed patellae manufactured from UHMWPE and CoCr alloy .

Available in sizes 29-38, tri-peg design with porous coating ■
The ADVANCE® patellar components were evaluated via mechanical testing and engineering analyses; including static stability, contact area, and interface strength. In addition, the porous coating for the metal-backed design was fully characterized as well as tested in static shear. A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

C. Substantial Equivalence Information

The indications for use of the ADVANCE® Total Knee System are unchanged as a result of the addition of the subject patellar components. The design features and materials of the subject devices are identical to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the patellae of the ADVANCE® Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.

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

March 21, 2013

Wright Medical Technology, Incorporated % Ms. Danielle Mueller Project Manager 5677 Airline Road Arlington, Tennessee 38002

Re: K122218

Trade/Device Name: ADVANCE® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH, JWH Dated: February 19, 2013 Received: February 20, 2013

Dear Ms. Mueller:

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 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

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Page 2 – Ms. Danielle Mueller

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,

Image /page/3/Picture/7 description: The image shows the name "Erin J. Keith" in a stylized font. The letters are bold and black, with a decorative design around the "J" and "Keith". The overall design appears to be a logo or signature.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122218

Device Name: ADVANCE® Total Knee System

Indications For Use:

The ADVANCE® Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. Inflammatory degenerative joint disease including rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Porous-coated total knee replacement components are for use without bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.