Indicated for use in total 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; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. For cemented use only.

Device Description

The ADVANCE® Modular Tibial Component is part of the ADVANCE® Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE® Modular Tibial Component is a modular component consisting of a tibial base, optional tibial augments, and optional stem extensions, all manufactured from titanium alloy. The base is offered both nonporous and porous coated, and features screw holes for optional fixation of the augments or for screw fixation. The base is designed for use with the ADVANCE® tibial inserts and the ADVANCE® femoral and patellar components cleared in previous premarket notifications. All components are intended to be used only with bone cement.

AI/ML Overview

The ADVANCE® Modular Tibial Component is a medical device for knee arthroplasty. The provided text outlines the acceptance criteria and the studies conducted to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Cyclic Fatigue Testing	Withstand at least 2.2 x body weight at 10 million cycles (ASTM F04.22.12)	Porous and nonporous titanium tibial bases demonstrated the ability to withstand at least 2.2 x body weight at 10 million cycles under test conditions.
Fatigue Testing	Withstand loads of up to 492 pounds for 1 million cycles (ASTM F04.22.01)	Results demonstrate the assembly's ability to withstand loads of up to 492 pounds for 1 million cycles.
Axial Distraction Testing	Demonstrate adequate results under extreme conditions	Testing demonstrates adequate results under extreme conditions. Testing confirms the taper connection's integrity.
Static Shear Strength	Adequate (ASTM F-1044)	Results from testing performed according to ASTM F-1044 demonstrate that the static shear strength of the porous coating is adequate.
Porous Coating Morphology	Distance between particles and mean intercept length in the range of 50 to 114 microns (suggested as optimum for bone ingrowth by Bobyn, et al.)	Stereological evaluation of the porous coating demonstrates that the distance between particles and mean intercept length measured are in the range of 50 to 114 microns suggested as optimum for bone ingrowth by Bobyn, et al.

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

The provided text does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for cyclic fatigue). The data provenance is from retrospective laboratory testing performed by Wright Medical Technology, Inc., for regulatory submission in the United States.

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

Not applicable. The ground truth for this device's performance is established through physical and mechanical engineering tests against pre-defined ASTM standards and scientific literature (e.g., Bobyn, et al. for porous coating). Expert clinical judgment is not directly used to establish the "ground truth" for these performance metrics, but rather to define the standards themselves.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation by multiple human readers (e.g., radiologists). The performance of this device is assessed through objective, quantitative, and standardized engineering tests, not subjective interpretation.

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. This is a medical device (implantable component), not an AI diagnostic or assistive technology. MRMC studies are not relevant to its type of assessment.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacture, not an algorithmic output.

7. The type of ground truth used

The ground truth used for evaluating the ADVANCE® Modular Tibial Component is based on established engineering and material science standards (ASTM standards) and scientific literature (e.g., research by Bobyn, et al. on bone ingrowth). These standards define the acceptable performance parameters for the device's mechanical integrity and biological interaction (porous coating).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set. The "training" in this context would be the iterative design and development process, which is not quantified by a "sample size" in the same way an AI model's training data is.

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

Not applicable, as this is not an AI device. The "ground truth" for the device's design and manufacturing specifications would be established through a combination of engineering principles, biomechanical analysis, clinical needs assessment, and adherence to industry regulations and standards.

Summary

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K9 7 35 24

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number: 901-867-9971.

DEC 1 2 1997

Contact Person: Kim Tompkins Date Prepared: September 16, 1997

510(k) Summary

Trade Name:	ADVANCE® Modular Tibial Component
Common Name:	Metal-backed Tibial Component
Product Classification:	II
Predicate Device:	AXIOM® Modular Tibial Component and ADVANCE® Cobalt Chrome Tibial Component manufactured by Wright Medical Technology, Inc.

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.

Description/Intended Use

The ADVANCE® Modular Tibial Base Component is indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflam-matory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.

Testing Summary

Cyclic fatigue testing was performed according to ASTM F04.22.12. The porous and nonporous titanium tibial bases demonstrated to ability to withstand at least 2.2 x body weight at 10 million cycles under test conditions. Fatigue testing was performed according to ASTM F04.22.01. Results demonstrate the assembly's ability to withstand loads of up to 492 pounds for 1 million cycles. Axial distraction testing demonstrates adequate results under extreme conditions. Testing confirms the taper connection's integrity. Results from testing performed according to ASTM F-1044 demostrate that the static shear strength of the porous coating is adequate. Stereological evaluation of the porous coating demonstrates that the distance between particles and mean intercept length measured are in the range of 50 to 114 microns suggested as optimum for bone ingrowth by Bobyn, et al

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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 with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 1997

Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technoloqy, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re : K973524 ADVANCE® Modular Tibial Component Regulatory Class: II Product Code: JWH Dated: September 16, 1997 Received: September 17, 1997

Dear Ms. Tompkins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

The thinnest tibial insert available is the nominal 1 . "10mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.0 mm.
1. This device may not be labeled or promoted for noncemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Ms. Kim Tompkins

1. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
  The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ರ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Ms. Kim Tompkins

obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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C. Indications For Use of the Device

Page 1 of 1

510(k) Number (if known):	K973524
Device Name:	ADVANCE® Modular Tibial Component
Indications for Use:
	Indicated for use in total 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;
	2) inflammatory degenerative joint disease including rheumatoid arthritis;
	3) correction of functional deformity;
	4) revision procedures where other treatments or devices have failed; and
	5) treatment of fractures that are unmanageable using other techniques.
	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)

Signature
(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K973524

Prescription Use_X_ Or (Per 21 CFR 801.109)

Over-the-Counter Use____

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.