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 NexGen TM Cone Broach, a 2-piece instrument (Broach and Handle), are manufactured from 17-4 stainless steel and designed to provide a multi-functional instrument to streamline the surgical process used when implanting the Trabecular Metal Tibial Cone Implants. The broaches are used to prepare the tibial metaphysis; the broach have teeth that are necessary to cut through bone and form the tibial canal to the correct shape and depth for a Trabecular Metal Tibial Cone Implant. The broaches are manually impacted, using a sequentially larger broach until reaching the final size for the Implant.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "NexGen® Complete Knee Solutions Trabecular Metal Cone Broach." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria.

Therefore, the information typically requested regarding acceptance criteria, study design, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this regulatory submission.

The document focuses on demonstrating that the new broach is substantially equivalent to existing, legally marketed broaches by comparing design, materials, function, and principle of operation.

Here's a breakdown of what can be extracted from the document regarding the device and its comparison, but again, this is not an acceptance criteria vs. performance study result:

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

This information is not provided in the document. The document is for a Class II medical device (surgical tools) and relies on substantial equivalence to predicate devices, not on proving clinical performance against specific acceptance criteria with reported metrics.

2. Sample sized used for the test set and the data provenance

This information is not provided. As it's a regulatory submission for a surgical instrument demonstrating substantial equivalence, a "test set" in the context of clinical performance data is not applicable here. The comparison is based on engineering and design characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Ground truth establishment as described for analytical or clinical studies is not relevant to this regulatory clearance process.

4. Adjudication method for the test set

This information is not provided. An adjudication method is not relevant for this type of regulatory submission.

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

This information is not applicable/provided. This device is a surgical broach, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study related to human readers and AI assistance would not be performed for this type of device.

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

This information is not applicable/provided. As above, this is a surgical instrument, not an algorithm.

7. The type of ground truth used

This information is not provided. Ground truth in the context of clinical outcomes or diagnostic accuracy is not relevant to this regulatory submission. The "truth" being established here is that the device is substantially equivalent to predicates in terms of design, materials, and intended use.

8. The sample size for the training set

This information is not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

This information is not provided. This question is not applicable to the device or the type of regulatory submission.

Summary of Device Comparison (from "Comparison to Predicate" section, which serves as the basis for substantial equivalence, not a performance study):

The document states that the NexGen TM Cone Broach is comparable to its predicate devices based on:

Function: Both are non-sterile, reusable manual orthopedic instruments that perform the same function (preparation of the tibial metaphysis).
Materials: Manufactured from identical materials (17-4 stainless steel).
Design: The design mimics currently marketed cone implants to prepare the tibial canal.
Principle of Operation: Uses the same principle of manual, sequential impaction with a mallet.
Improvements: The new device adds design-specific Coupled broaches and Large broach sizes for a full line of Cone Implants and replaces a manual burring step. This additional functionality streamlines the surgical procedure.
Safety and Effectiveness: The conclusion is that the TM Cone Broach is "as safe and effective" as the predicate instrumentation.

Summary

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

September 3, 2014

Zimmer, Incorporated Ms. Diana Taylor Regulatory Affairs Senior Specialist P.O. Box 708 Warsaw, Indiana 46580

Re: K141840

Trade/Device Name: NexGen® Complete Knee Solutions Trabecular Metal Cone Broach 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: July 07, 2014 Received: July 08, 2014

Dear Ms. Taylor:

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 comply with all the Act's requirements, including, but not limited to: registration and listing

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(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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

K141840

Device Name

NexGen® Complete Knee Solutions Trabecular Metal Cone Broach

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Diana TaylorRegulatory AffairsTelephone: (574) 267-6131Fax: (574) 372-4605
Date:	July 7, 2014
Trade Name:	NexGen® Complete Knee Solutions Trabecular MetalCone Broach
Common Name:	Broach
Classification:	Class II Accessory21 CFR 21 888.3560 and 21 CFR 888. 3565
Product Code:	JWH and MBH
Classification Panel:	Orthopedics
Predicate Device(s):	Trabecular Metal Tibial Cone Augments manufactured byTrabecular Metal Technologies, K102896, 12/13/2010
	NexGen Trabecular Metal Coupled Tibial Conesmanufactured by Trabecular Metal Technologies, K120990,06/29/2012.
Description:	The NexGen TM Cone Broach, a 2-piece instrument (Broachand Handle), are manufactured from 17-4 stainless steel anddesigned to provide a multi-functional instrument tostreamline the surgical process used when implanting theTrabecular Metal Tibial Cone Implants.
	The broaches are used to prepare the tibial metaphysis; thebroach have teeth that are necessary to cut through bone andform the tibial canal to the correct shape and depth for aTrabecular Metal Tibial Cone Implant. The broaches aremanually impacted, using a sequentially larger broach untilreaching the final size for the Implant.

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Indications for Use: 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.
Comparison to Predicate: Both the NexGen TM Cone Broach and the predicate broach are non-sterile, reusable manual orthopedic instruments that perform the same function as the predicate, are manufactured from identical materials, design mimics the currently marketed cone implants in order to prepare the tibial canal for Trabecular Metal Cone Implants using the same principal of operation (manual, sequential impaction with a mallet). The addition of design specific Coupled broaches and Large broach sizes provides design specific instrumentation for the full line of Cone Implants. The Large broach replaces a challenging manual burring step. The additional functionality of the instrumentation allows the surgical procedure to be streamlined. The TM Cone Broach is as safe and effective as the predicate instrumentation used to implant the Coupled, Medium and Large Trabecular Metal Cone Implants.
Substantial Equivalence Zimmer considers this 2-piece broach equivalent to the Conclusions predicate one-piece broach based on design, size range and performance.

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.