The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity:
revision procedures where other treatments or devices have failed; and 4)
treatment of fractures that are unmanageable using other techniques. ૨)

The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

Device Description

The design features of the ADVANCE® Spiked Porous Tibial Base are described below.

4 spikes on the distal surface .
. Available with or without screw holes
Manufactured from titanium alloy .
Titanium porous coating .

AI/ML Overview

This submission describes a medical device, the ADVANCE® Spiked Porous Tibial Base, which is a knee implant component. The provided text is a 510(k) summary for premarket notification to the FDA. For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance as one might expect for a digital health or AI/ML device is not directly applicable.

Instead, the FDA 510(k) process for devices like the ADVANCE® Spiked Porous Tibial Base relies on demonstrating substantial equivalence to a previously cleared predicate device. This means showing that the new device is as safe and effective as a legally marketed device.

Here's how to interpret the request based on the provided document:

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

Since this is a substantial equivalence submission for a physical implant, "acceptance criteria" isn't about specific performance metrics like sensitivity, specificity, or accuracy (as it would be for a diagnostic AI). Instead, the "acceptance criteria" are implied by the requirements for substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence via 510(k))	Reported Device Performance (as demonstrated by the submission)
Intended Use Equivalence: The new device has the same intended use as legally marketed predicate device(s).	The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions such as noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, revision procedures, and treatment of unmanageable fractures. This aligns with the generally accepted indications for knee arthroplasty components. The submission states, "The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices."
Technological Characteristics Equivalence: The new device has the same technological characteristics as the predicate device(s), or if there are differences, those differences do not raise different questions of safety and effectiveness.	Design Features: - 4 spikes on the distal surface. - Available with or without screw holes. - Manufactured from titanium alloy. - Titanium porous coating. The submission explicitly states, "The design features of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to the design features of other devices previously cleared for market." Materials: Manufactured from titanium alloy with titanium porous coating. The submission states, "The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices." This implies the material is also equivalent or does not raise new safety/effectiveness concerns.
Performance Data: If differences in technological characteristics exist, appropriate data (e.g., non-clinical bench testing, clinical data) are provided to demonstrate that the device is as safe and effective as the predicate device.	The summary states: "The safety and effectiveness of the ADVANCE® Spiked Porous Tibial Base is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." While specific bench testing results (e.g., fatigue, wear, fixation strength) are not detailed in this summary, the general statement confirms that such data were provided to the FDA as part of the full 510(k) submission to support the claim of substantial equivalence. This type of submission would typically include biomechanical testing relevant to the implant's function and material properties.

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

For a 510(k) submission based on substantial equivalence for a physical implant, there is typically no "test set" in the sense of a clinical dataset used to evaluate diagnostic accuracy or AI model performance. The "testing" primarily refers to non-clinical bench testing (e.g., mechanical strength, corrosion, wear) and material characterization, guided by established standards for orthopedic implants.

Sample Size: Not applicable in the context of a "test set" for performance metrics like AI. For bench testing, samples are typically specimens of the device or its materials. The number of samples would depend on the specific test and relevant ASTM/ISO standards.
Data Provenance: Not applicable in the context of clinical data. Bench testing is performed in laboratories, not on patient data.

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. There is no concept of "ground truth" established by experts for a test set in a 510(k) for a physical implant. The evaluation is against engineering specifications, material standards, and comparisons to legally marketed predicate devices.

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

Not applicable. This is relevant for clinical or image-based studies requiring consensus, not for mechanical device equivalence.

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:

Not applicable. MRMC studies are used for evaluating diagnostic imaging devices or AI-assisted diagnostic tools, not physical implants.

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

Not applicable. This device is a physical knee implant, not an algorithm.

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

Not applicable. The "ground truth" for this type of device relies on established engineering principles, material science, and the long-term clinical performance and safety profile of the predicate devices. The "truth" is that the device meets safety and performance standards equivalent to similar, already-approved devices.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

Not applicable.

Summary

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K063128

MAR 2 1 2007 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® Spiked Porous Tibial Base.

Submitted By:	Wright Medical Technology, Inc.
Date:	October 11, 2006
Contact Person:	Theresa Leister
	Regulatory Affairs Specialist II
Proprietary Name:	ADVANCE® Spiked Porous Tibial Base
Common Name:	Tibial Base
Classification Name and Reference:	21 CFR 888.3565 Prosthesis, Knee,Patello/femorotibial, Semi-Constrained,Uncemented, Porous Coated,Polymer/Metal/Polymer - Class II
Device Product Code and Panel Code:	Orthopedics/87/MBH

DEVICE INFORMATION

A. INTENDED USE

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity:
revision procedures where other treatments or devices have failed; and 4)
treatment of fractures that are unmanageable using other techniques. ર)

The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

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B. DEVICE DESCRIPTION

The design features of the ADVANCE® Spiked Porous Tibial Base are described below.

4 spikes on the distal surface .
. Available with or without screw holes
Manufactured from titanium alloy .
Titanium porous coating .

The design features of ADVANCE® Spiked Porous Tibial Base are substantially equivalent to the design features of other devices previously cleared for market.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ADVANCE® Spiked Porous Tibial Base is 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 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Theresa Leister Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

MAR 2 1 2007

Re: K063128

Trade/Device Name: ADVANCE Spiked Porous Tibial Base 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: March 8, 2007 Received: March 9, 2007

Dear Ms. Leister:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Theresa Leister

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oarbara Bneelus

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K063128

Device Name: ADVANCE® Spiked Porous Tibial Base

Indications For Use:

noninflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis, or avascular necrosis;
inflammatory degenerative joint disease including rheumatoid arthritis; 2)
correction of functional deformity; 3)
revision procedures where other treatments or devices have failed; and 4)
1. treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

Prescription Use × (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)

1 of 1

Barbara Buelup

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K063128

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.