Trabecular Metal Tibial 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

Device Description

The existing, commercially available NexGen® Trabecular Metal™ Tibial Cone Augments are manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. The devices which are the subject of this 510(k), the modified NexGen Trabecular Metal Tibial Cone Augments are also manufactured of the same Trabecular Metal material, using the same methods as the predicate device. The existing, commercially available NexGen Trabecular Metal Tibial Cone Augments have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. A similar taper pattern is also present in the modified tibial cones.

Both the modified tibial cones augments and the existing, commercially available tibial cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems- both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Tibial Bases and the tibial component of Zimmer's Rotating Hinge Knee (RHK) System. Fixation of all of the cone augments to the tibial implant is accomplished by cementing the superior portion of the augment to the underside of the tibial baseplate. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK tibial implant and with cement for the RHK tibial implant. With all of these tibial cone augments the LCCK tibial baseplate inferior surface must be cemented to the bone and the required stem extensions can either be cemented or press-fit.

The existing, commercially available augments come in four medium & large sizes, two height options and stepped augments. They can be used in conjunction with Zimmer's LCCK or RHK Knee Systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer Trabecular Metal™ Tibial Cone Augments:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Predetermined requirements established for mechanical performance during normal gait activities (walking and deep flexion).	Met: The results of testing and analyses conducted demonstrate that the proposed implants adequately meet the predetermined requirements established for its mechanical performance.

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

The study described is a Finite Element Analysis (FEA), which is a computer simulation, not a study involving physical samples or human patients as a "test set" in the traditional sense. Therefore, concepts like "sample size" for a test set and "country of origin of the data" are not directly applicable. The data provenance would be the computational models and parameters used in the FEA.

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

Since this was an FEA study, the concept of "ground truth" derived from expert review of patient data is not applicable. The "ground truth" for an FEA study would be the underlying physics and engineering principles validated through previous research and material properties. The document does not specify experts involved in establishing this, but it implies reliance on established engineering and biomechanical principles.

4. Adjudication Method for the Test Set

Not applicable for an FEA study, as there is no human interpretation of data for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI or imaging diagnostic tool, so "human readers" and "AI assistance" are not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Again, this is not applicable as the device is a physical implant. The "standalone" performance here refers to the mechanical performance of the implant itself, which was assessed through the FEA.

7. The Type of Ground Truth Used

The ground truth used in this context is computational modeling and engineering principles, specifically validated through a Finite Element Analysis (FEA). The results of the FEA are compared against predetermined requirements for mechanical performance.

8. The Sample Size for the Training Set

Not applicable in the context of an FEA study. FEA models are built based on material properties, design specifications, and biomechanical loads. There isn't a "training set" of data in the sense of machine learning.

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

As above, the concept of a "training set" doesn't directly apply. The "ground truth" for an FEA model would be based on well-established engineering principles, material science data for Trabecular Metal and bone, and biomechanical studies defining forces during gait. These parameters are inputs to the FEA, not derived from a "training set" in the typical sense.

Summary of the Study:

The study undertaken to demonstrate device performance was a comparative Finite Element Analysis (FEA). This computational modeling technique was used to simulate the mechanical behavior of the proposed modified tibial cone augments under "normal gait activities (walking and deep flexion)." The goal was to determine if the modified design met predefined mechanical performance requirements and to compare its performance to the predicate device, thereby supporting substantial equivalence. The document states that the FEA results demonstrated that the implants adequately meet the predetermined requirements established for its mechanical performance, thus supporting their substantial equivalence.

Summary

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K102896 (V3)

DEC 1 3 2010

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Kathleen RutherfordAssociate Director, Regulatory AffairsTelephone: (973) 576-0139Fax: (973) 884-8792
Date:	September 30, 2010
Trade Name:	Trabecular Metal™ Tibial Cone Augments
Common Name:	Knee joint patellofemorotibial polymer/metal/polymer semiconstrained 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

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K102896(2/3)

augments to the tibial implant is accomplished by cementing the superior portion of the augment to the underside of the tibial baseplate. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK tibial implant and with cement for the RHK tibial implant. With all of these tibial cone augments the LCCK tibial baseplate inferior surface must be cemented to the bone and the required stem extensions can either be cemented or press-fit.

The existing, commercially available augments come in four medium & large sizes, two height options and stepped augments. They can be used in conjunction with Zimmer's LCCK or RHK Knee Systems.

INDICATIONS FOR USE

DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)

Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed implant to its predicate devices. The subject implant is identical to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation.

PERFORMANCE DATA

A comparative Finite Element Analysis (FEA) study was performed to determine whether the proposed design represented a worst case for the product line across different normal gait

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K102896(3/3)

activities (walking and deep flexion). The results of testing and analyses conducted demonstrate that the proposed implants adequately meet the predetermined requirements established for its mechanical performance, supporting substantial equivalence to the predicate Trabecular Metal™ Tibial Cones.

SUBSTANTIAL EQUIVALENCE

The NexGen® Trabecular Metal™ Tibial Cone Augments product line extension is the same as the predicate devices with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting tests and descriptions, this product line extension does not present any new issues of safety or effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling 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 % Ms. Kathleen Rutherford 10 Pomeroy Road Parsippany, New Jersey 07054

@EC 1 3 2010

Re: K102896

Trade/Device Name: Zimmer Trabecular Metal™ Tibial 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: September 30, 2010 Received: September 30, 2010

Dear Ms. Rutherford:

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 or my 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kathleen Rutherford

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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

AZ B Rh

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

Enclosure

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Indications for Use

510(k) Number (if known): K10289 b

DEC 1 3 2010

Device Name: Trabecular Metal Tibial Cone Augment

Indications for Use:

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)

Page 1 of 1

for M. Wilkerson

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

510(k) Number K102896

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

Page 16

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.