Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

Device Description

The NexGen® Trabecular Metal™ Femoral Cone Augments are manufactured wholly of Trabecular Metal™, porous tantalum. The existing, commercially available NexGen® Trabecular Metal™ Femoral Cone Augments have a tapered elliptical cross-section. The periphery of the distal end is larger than that of the proximal end. The cone is not fully enclosed at its top most proximal section (giving the impression of U-Shape through slot). A similar pattern is also present in the modified femoral cones, with the exception that these cones are fully enclosed at its top most proximal section.

Both the modified femoral cones augments and the existing, commercially available femoral cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems -both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Femoral Implant and the femoral component of Zimmer's Rotating Hinge Knee (RHK) System. When used with the RHK System, the Trabecular Metal™ Femoral Cone Augments are for cemented use only. Fixation of all of the cone augments to the femoral implant is accomplished by cementing the internal portion of the augment to the superior side (non-articulating side) of the femoral component. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK femoral implant and with cement for the RHK femoral implant.

The existing, commercially available augments come in three sizes; small, medium and large and three height options. The proposed additional femoral cones will come in the same three sizes: small, medium and large and two height options.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

This document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for novel performance criteria. As such, information regarding AI-specific studies, ground truth establishment, and expert involvement for evaluation of an AI model will not be found in this type of submission.

Therefore, many of the requested categories related to AI performance metrics cannot be directly extracted from this document. The "device" in question is a physical orthopedic implant, not an AI system.

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

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Material Properties	Properties of Trabecular Metal™ (porous tantalum) defined by:	- Static compression- Static shear- Axial compression fatigue- Rotational beam fatigue- Young's modulus of elasticity (in tension and compression)
Mechanical Performance (Predicate Devices)	Maintain assembly integrity using surgical technique instructions after:	- Fatigue testing- Wear testing- Assembly torque testing
Mechanical Performance (Proposed Device - Strength)	Adequately meets predetermined requirements for mechanical performance during normal gait activities (walking, stair ascent/decent, deep flexion).	- Comparative Finite Element Analysis (FEA) study demonstrated adequate strength.
Substantial Equivalence	- Same material as previously cleared predicate devices.- Identical intended use and indications for use as predicate devices.- Similar sizes, cross-sectional dimensions, design features, and overall geometry to predicate device.- No significant differences that would adversely affect product use.- No new issues of safety and efficacy raised by technological characteristics.	- All criteria met and detailed in the "DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES" and "CONCLUSION" sections. The FDA concurred with substantial equivalence (K103517).

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

Test Set Sample Size: Not applicable. The "tests" here are mechanical engineering tests (material properties, fatigue, wear, FEA), not human subject or imaging dataset evaluations for an AI model. The sample sizes for these engineering tests are not specified in the summary, nor is the "provenance" in the context of data origin relevant for these types of physical tests.

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)

Number of Experts & Qualifications: Not applicable. This information is relevant for AI model validation where human experts establish ground truth for image interpretation or diagnosis. For mechanical testing of an orthopedic implant, "ground truth" is typically defined by engineering specifications, material standards, and validated simulation models, carried out by engineers and material scientists. The document does not specify the number or qualifications of experts involved in the material property or FEA analyses beyond stating that analyses were conducted.

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

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI performance evaluations to resolve disagreements among human annotators or diagnosticians when establishing ground truth. For mechanical engineering tests and FEA, the results are typically derived algorithmically or through physical measurement against established engineering standards, not through expert adjudication in this typical sense.

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

MRMC Study / AI Assistance: No. This device is a physical knee implant, not an AI system. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not relevant and was not performed.

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

Standalone Algorithm Performance: No. This device is a physical knee implant, not an AI algorithm. "Standalone performance" in this context refers to the algorithm's performance without human interaction, which is not applicable. The device itself performs its mechanical function "stand-alone" in the body, but this is a different meaning than used for AI.

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

Type of Ground Truth: For the mechanical aspects, the "ground truth" is based on:
- Engineering Specifications and Standards: "Predetermined requirements established for its mechanical performance."
- Material Science Principles: Properties of Trabecular Metal™ measured against established scientific understanding.
- Validated Mechanical Testing Methods: Fatigue, wear, and assembly torque testing.
- Finite Element Analysis (FEA) Models: Computational models validated against physical principles and potentially prior experimental data.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This submission is for a physical medical device, not an AI model requiring a training set.

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

Ground Truth for Training Set: Not applicable. No AI model or training set is mentioned in the document.

Summary

{0}------------------------------------------------

K103517 * 1/3 FEB 15 2011

510(k) Summary

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Judith RosenSenior Regulatory Affairs SpecialistTelephone: (973) 576-0032 ext 28138Fax: (973) 884-8792
Date:	November 30, 2010
Trade Name:	Trabecular Metal™ Femoral Cone Augments
Common Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented and uncemented
Classification Name:	"Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis";and"Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis"
Reference:	21 CFR § 888.3560, JWH and 21 CFR § 888.3565, MBH

DEVICE DESCRIPTION

{1}------------------------------------------------

K103517A²/₃

INDICATIONS FOR USE

DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES

The NexGen® Trabecular Metal™ Femoral Cone Augments were shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are Zimmer's Trabecular Metal™ Femoral Cone Augments (K040630, K051756, K053340), Zimmer's NexGen® Trabecular Metal™ Tibial Cone Augments (K031962, K053340), Zimmer's NexGen® Complete Knee Solution - Trabecular Metal™ Augments (K024161, K040487), Zimmer's (formerly Implex) Continuum Knee System Trabecular Metal™ (formerly Hedrocel®) Tibial Spacers (K982302), and Zimmer's (formerly Implex) Continuum Knee System Trabecular Metal™ (formerly Hedrocel®) Revision Femoral Spacers (K0980781).

The NexGen® Trabecular Metal™ Femoral Cone Augments have the same material as previously cleared predicate devices. The intended use and indications for use of the subject devices are identical to that of the predicate. This submission is for an extension of the product line; sizes, cross sectional dimensions, design features and overall geometry of the device in the current submission are similar to the predicate device.

There are no significant differences between the proposed NexGen® Trabecular Metal™ Femoral Cone Augments and the predicate currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety and efficacy.

PERFORMANCE DATA

Performance testing of Trabecular Metal™ material is included in a master file, on file at the FDA, which includes static compression, static shear, axial compression fatigue and rotational beam fatigue. Young's modulus of elasticity of Trabecular Metal has been measured in tension and compression. The results of testing and analysis define the properties of Trabecular Metal™, porous tantalum.

Mechanical testing was performed on Trabecular Metal predicate devices which include fatigue testing, wear testing, and assembly torque testing. The results of testing and analyses conducted indicate that predicates of the Trabecular Metal™ Femoral Cone Augments should maintain assembly integrity when assembled using the surgical technique instructions.

{2}------------------------------------------------

KI03517 #3/3

A comparative Finite Element Analysis (FEA) study was performed to evaluate the strength of the proposed femoral cone designs across different normal gait activities (walking, stair ascent/decent and deep flexion). The results of testing and analyses conducted demonstrate that the proposed implant adequately meets the predetermined requirements established for its mechanical performance, supporting substantial equivalence to the predicate.

CONCLUSION

The NexGen® Trabecular Metal™ Femoral Cone Augments product line extension is the same as the predicate device with respect to intended use/indications for use, technological characteristics and basic principles of operation. This product line extension does not present any new issues of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Zimmer Trabecular Metal Technology, Inc. % Ms. Judith Rosen 10 Pomeroy Road Parsippany, New Jersey 07054

FEB 15 201

Re: K103517

Trade/Device Name: Trabecular Metal Femoral Cone Augments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: November 30, 2010 Received: November 30, 2010

Dear Ms. Rosen:

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

{4}------------------------------------------------

Page 2 – Ms. Judith Rosen

comply with all the Act's requirements, including, but not limited to: registration and lising (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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aliz B. nh
for

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K103517

Device Name: Trabecular Metal Femoral Cone Augment

Indications for Use:

ﺳﻴﺪ ﺳﻴﺔ

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page1of1

for M.Mclkrøm

(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103517

Zimmer TMT, Inc. Traditional 510(k) - Trabecular Metal Femoral Cone Augments

PROPRIETARY AND CONFIDENTIAL

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.