Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:

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.
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.

Device Description

The ADVANCE® Unicondylar modular metal-backed tibia is part of the ADVANCE® Unicondylar Knee System that was previously submitted and cleared under 510(k): K012591- ADVANCE® Unicondylar Knee System. Wright Medical Technology is now enhancing the ADVANCE® Unicondylar Knee System by adding a modular titanium metal-backed UHMWPE tibial component. The ADVANCE® Unicondylar Knee System now contains the following components; Co-Cr femoral component, all-poly ultra-high molecular-weight polyethylene (UHMWPE) tibial component and modular titanium metal-backed UHMWPE tibial component.
The ADVANCE® Unicondylar femoral component is identical to the femoral component previously submitted and cleared under ADVANCE® Unicondylar Knee System -510(k): K012591.
The ADVANCE® Unicondylar all-poly tibial component is identical to the all-poly tibial component previously submitted and cleared under ADVANCE® Unicondylar Knee System - 510(k): K012591.
The ADVANCE® Unicondylar modular metal-backed tibial base is manufactured from The ADVANCE® Unicondylar modular tibial insert is titanium (ASTM F136). manufactured from the identical UHMWPE as the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The profile and sizing (Sizes 1, 2, 3 & 4) of the ADVANCE® Unicondylar modular metal-backed tibial components are identical to the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The cement interface for the ADVANCE® Unicondylar modular metal-backed tibial components consist of a peripheral dovetail and two pegs and is substantially equivalent to the cement interface of the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The articulating surface is identical for both the ADVANCE® Unicondylar modular metal-backed tibial insert and the all-poly tibial component (510(k): K012591). The locking mechanism for the ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANTIM® Unicondylar modular metalbacked tibial components (510(k): K881779).

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the ADVANCE® Unicondylar Knee System, specifically for an enhancement to the system by adding a modular titanium metal-backed UHMWPE tibial component. It is a premarket notification to the FDA, demonstrating "substantial equivalence" to legally marketed predicate devices, rather than a study proving performance against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and sample size/ground truth for training sets) are not applicable or available in this type of regulatory submission.

The document demonstrates compliance through "substantial equivalence" to previously cleared devices. This means the new device is as safe and effective as a legally marketed device (the predicate device) that is already on the market.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison)
Intended Use (Must be the same as or very similar to predicate devices)	The ADVANCE® Unicondylar Knee System has an identical intended use to previously cleared devices (K012591 and K881779) for knee arthroplasty to reduce pain/improve function in skeletally mature patients with specified conditions (degenerative joint disease, inflammatory disease, functional deformity, revision procedures, unmanageable fractures) and unicompartmental joint disease with intact ligaments.
Material (Must be the same as or bioequivalent to predicate devices)	Tibial Insert Material: UHMWPE, identical to the material used for the ADVANCE® Unicondylar All-Poly Tibial Component (K012591) and the ADVANTIM® Unicondylar modular metal-backed tibial base (K881779). Tibial Base Material: Titanium, identical to the material used for the ADVANTIM® Unicondylar modular metal-backed tibial base (K881779).
Cement Interface (Must be substantially equivalent to predicate devices)	Design: 2 pegs with a peripheral dovetail. Performance: Substantially equivalent to the ADVANCE® Unicondylar All-Poly Tibial Component (K012591).
Articulating Surface (Must be identical or substantially equivalent)	Design: Identical to the articulating surface used on the ADVANCE® Unicondylar All-Poly Tibial Component (K012591).
Profile/Sizing (Must be identical or substantially equivalent)	Design: Identical profile and sizing scheme (Sizes 1, 2, 3 & 4) as the ADVANCE® Unicondylar All-Poly Tibial Component (K012591).
Locking Mechanism (For modular components, compared to similar predicate designs)	Design: Peripheral lock. Performance: Substantially equivalent to the ADVANTIM® Unicondylar modular metal-backed tibial components (K881779). This feature is not applicable to the all-poly component as it is one piece.
Overall Safety and Effectiveness (Supported by substantial equivalence information, materials data, and testing results)	The safety and effectiveness of the ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification, concluding it is substantially equivalent to the ADVANTIM® Unicondylar Femoral component (K881779) and other previously cleared predicate devices.

Important Note: The "device performance" in this context refers to the demonstration of equivalence to existing devices, not clinical outcomes from a new study against specific performance metrics for a novel technology.

Study Details (as inferable from a 510(k) submission)

Sample size used for the test set and the data provenance: Not applicable. A 510(k) submission for substantial equivalence generally does not involve a "test set" or clinical study with patient data in the way a novel device might. The "test set" here would be the design features and materials compared against predicate devices. The data provenance is regulatory history of predicate devices (K012591, K881779) and material performance data which would be referenced but not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context is established by the design specifications and regulatory clearances of the predicate devices themselves, as well as established industry standards for materials and mechanical testing (though specific experts for this are not mentioned in this summary).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This device is a knee implant, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for demonstrating substantial equivalence is the safety and effectiveness profile of the legally marketed predicate devices, as established by their prior FDA clearances and accepted manufacturing standards. This includes material specifications (ASTM F136 for titanium, UHMWPE), design parameters, and functional characteristics.
The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning/AI device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Wright Medical Technology, Inc. The logo includes a stylized "W" and the company name in bold, sans-serif font. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002. At the top of the image is the number K014171.

MAR 1 5 2002

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® Unicondylar Knee System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

December 19, 2001

Ehab M. Esmail Manager, Regulatory Affairs

ADVANCE® Unicondylar Knee System

UNICONDYLAR KNEE SYSTEM

21 CFR 888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer -Class II

21 CFR 888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer -Class II

Device Product Code and Panel Code:

Orthopedics/87/ HSX, HRY

DEVICE INFORMATION

A. INTENDED USE

Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:

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
1. treatment of fractures that are unmanageable using other techniques.

Image /page/0/Picture/27 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of the word "WRIGHT" in a bold, sans-serif font, with the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font below it. Above the word "WRIGHT" is a stylized "W" shape, which is formed by two overlapping triangles. The logo is black and white.

Image /page/0/Picture/28 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is depicted in black and white and appears to be a simple illustration. The continents are outlined, and the oceans are left blank, creating a clear contrast. The globe is set on a stand, suggesting it is a physical object.

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K014171

Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.

The ADVANCE® Unicondylar Knee System components are for single use only.

The ADVANCE® Unicondylar Knee System components are for cemented use only.

B. DEVICE DESCRIPTION

The ADVANCE® Unicondylar femoral component is identical to the femoral component previously submitted and cleared under ADVANCE® Unicondylar Knee System -510(k): K012591.

The ADVANCE® Unicondylar all-poly tibial component is identical to the all-poly tibial component previously submitted and cleared under ADVANCE® Unicondylar Knee System - 510(k): K012591.

The ADVANCE® Unicondylar modular metal-backed tibial base is manufactured from The ADVANCE® Unicondylar modular tibial insert is titanium (ASTM F136). manufactured from the identical UHMWPE as the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The profile and sizing (Sizes 1, 2, 3 & 4) of the ADVANCE® Unicondylar modular metal-backed tibial components are identical to the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The cement interface for the ADVANCE® Unicondylar modular metal-backed tibial components consist of a peripheral dovetail and two pegs and is substantially equivalent to the cement interface of the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The articulating surface is identical for both the ADVANCE® Unicondylar modular metal-backed tibial insert and the all-poly tibial component (510(k): K012591). The locking mechanism for the ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANTIM® Unicondylar modular metalbacked tibial components (510(k): K881779). Table 1 is a comparison chart summarizing the above design features for the ADVANCE® Unicondylar modular metalbacked tibial components.

Image /page/1/Figure/10 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

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Abbreviated 510(k) ADV ANCE® Unicondylar Knee System 510(K) SUMMARY Page 3 of 3

Design Feature	ADVANCE® Unicondylar All-PolyTibial Component(510(k): K012591)	ADVANCE® Unicondylar ModularMetal-Backed Tibial Components
Material	All-poly Tibial Component - UHMWPE(previously submitted and cleared underADVANCE® Unicondylar Knee System –510(k): K012591)	Tibial Insert - UHMWPE – Insert (Identical to thematerial used for the ADVANCE® Unicondylar All-Poly Tibial Component - 510(k): K012591 and theADVANTIM® Unicondylar modular metal-backedtibial base- 510(k): K881779)Tibial Base - Titanium (Identical to material usedfor the ADVANTIM® Unicondylar modular metal-backed tibial base- 510(k): K881779)
Cement Interface	2 pegs with peripheral dovetail (previouslysubmitted and cleared under ADVANCE®Unicondylar Knee System – 510(k): K012591)	2 pegs with peripheral dovetail (substantiallyequivalent to the ADVANCE® Unicondylar All-Poly Tibial Component - 510(k): K01259)
ArticulatingSurface	Previously submitted and cleared underADVANCE® Unicondylar Knee System –510(k): 012591 -Exhibit 1	Identical to the articulating surface used on theADVANCE® Unicondylar All-Poly TibialComponent - 510(k): K012591
Profile/Sizing	Previously submitted and cleared underADVANCE® Unicondylar Knee System –510(k): 012591 -Exhibit 1	Identical profile and sizing scheme as theADVANCE® Unicondylar All-Poly TibialComponent - 510(k): K012591
LockingMechanism	Not Applicable (one piece all-poly tibialcomponent)	Peripheral lock is substantially equivalent to theADVANTIM® Unicondylar modular metal-backedtibial components (510(k): K881779)

Table 1 - Comparison Between the ADVANCE® Unicondylar Modular Metal-Backed Tibia
Components and the ADVANCE® Unicondylar All-Poly Tibial Component

The design features of ADVANCE® Unicondylar modular metal-backed tibial components are substantially equivalent to the design features of the ADVANCE® Unicondylar All-Poly Tibial Component - 510(k): K012591 and the ADVANTIM® Unicondylar modular metal-backed tibial base (Submitted and cleared under 510(k) -K881779 Whiteside Ortholoc II Unicondylar Knee System).

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the ADVANCE® Unicondylar Knee System are substantially equivalent to the ADVANTIM® Unicondylar Femoral component (Submitted and cleared under 510(k) - K881779 Whiteside Ortholoc II Unicondylar Knee System) and also to predicate devices previously cleared for market. The safety and effectiveness of the ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

Image /page/2/Picture/6 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and does not have a lot of detail.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K014171

Trade/Device Name: ADVANCE® Unicondylar Knee System Regulation Number: 21 CFR 888.3530 and 888.3520 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis and knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY and HSX

Dated: December 19, 2001 Received: December 20, 2001

Dear Mr. Esmail:

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 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.

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Page 2 - Mr. Ehab M. Esmail

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark McMullen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ADVANCE® Unicondylar Knee System

INDICATIONS STATEMENT

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:

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
1. treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Unicondylar Knee System components are for single use only.

The ADVANCE® Unicondylar Knee System components are for cemented use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Malkerson

General, Restorative ological Devices

510(k) Number K014171

Prescription Use (Per21 CFR 801.109) OR

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Over-The Counter Use (Optional Format 1-2-96)

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INDICATIONS STATEMENT

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.