The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

Device Description

Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.

The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Implant. For medical devices, "acceptance criteria" and "device performance" are typically related to the physical and mechanical properties of the device, and the "study" proving these are usually non-clinical (laboratory) tests. Clinical studies (with human subjects) are often not required for 510(k) clearances, especially if substantial equivalence to a predicate device can be demonstrated through non-clinical testing.

Here's the breakdown of the requested information based on the provided text, focusing on the absence of typical "AI/software algorithm" acceptance criteria and studies, as this is a dental implant:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format as might be seen for software performance metrics (e.g., sensitivity, specificity thresholds). Instead, it refers to performance standards for mechanical properties.

Acceptance Criteria Category	Reported Device Performance
Fatigue Testing	Meets standards in accordance with FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments.
Compression Testing	Meets standards in accordance with FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments.
Mechanical Strength	Demonstrated improvements over the predicate device.
Torque Testing (Apical Tip Strength)	Indicator that the strength at the apical tip of the implant is greater than the stress the implant will see in dense cortical bone, in accordance with internal Zimmer Research Protocols.

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

Sample Size for Test Set: Not explicitly stated. Non-clinical mechanical testing typically uses a certain number of samples, but the exact count is not provided in this summary.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no mention of country of origin for data as it's not patient data, nor is there a retrospective or prospective nature to the data.

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

This is not applicable for non-clinical mechanical testing of a dental implant. "Ground truth" in this context refers to established engineering standards and guidelines for mechanical performance, not expert medical consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical imaging studies. This document describes mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is a clinical study comparing human reader performance, often with and without AI assistance. This document explicitly states: "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No. This device is a physical dental implant, not a software algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for non-clinical testing is based on established engineering principles, industry standards (e.g., ISO standards for dental implants), and FDA guidance documents (specifically, the Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The device's ability to resist fatigue, compression, and maintain torque strength constitutes the "truth" against these predefined benchmarks.

8. The Sample Size for the Training Set

No. This is not applicable to the development and testing of a physical medical device like a dental implant. "Training set" refers to data used to train machine learning models.

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

Not applicable. As noted above, this relates to machine learning models, not physical device engineering.

Summary

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1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

510(k) SUMMARY (21CFR807.92(a))

Submitter's Information: 1.

Zimmer Dental Inc. Name: Address: 1900 Aston Ave. Carlsbad, CA 92008 760-929-4366 Phone: Contact: Julie Lamothe
Date Prepared: June 18, 2013
1. Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
  Trabecular Metal Implant 872.3640 DZE Implant, Endosseous, Root-Form
ని. Predicate Device(s):
Predicate Device No. 1 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Trabecular ScrewVent X Implant K112160, K113753 872.3640 DZE Implant, Endosseous, Root-Form

Screw Vent Dental Implant K013227, K061410 872.3640 DZE Implant, Endosseous, Root-Form

Device Description: 4.

NOV 1 9 2013

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osseointegration. In addition, the implant section is tapered with triple-lead threads.

న్. Indications for Use:

The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.

The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

6. Device Comparison:

The Zimmer Trabecular Metal Implant is similar to predicate device #2 Zimmer Screw Vent Implant (K013227, K061410), relative to mechanical strength and implant/abutment connection. The 3.7mmD Trabecular Metal device includes an assembly of Trabecular Metal (tantalum) to a titanium allov core similar to predicate device #1, Trabecular Metal Implant (K112160). The threaded portion of the implant will have a tapered body with triple lead thread design, and the Trabecular Metal portion of the implant is cylindrical. The Trabecular Metal is a 3D structure similar to cancellous bone that will allow for bone

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ingrowth. The new implant will be offered in a 3.7mm diameter in lengths of 10, 11.5, 13 and 16mm.

1. Technological Characteristics

Feature	New DeviceZimmer Trabecular MetalImplant	Predicate 1Zimmer Trabecular MetalImplant	Predicate 2Screw-Vent DentalImplant
ImplantInterface	Internal Hex	Internal, Hex	Internal Hex
Implant Lengths	10mm, 11.5mm, 13mm,16mm	8.0mm, 10mm, 11.5mm,13mm, 16mm	8.0mm, 10mm, 13mm,16mm
ImplantDiameters	3.7mm	4.1mm, 4.7mm, 6.0mm	3.3mm, 3.7mm, 4.7mm
Material	Titanium 6Al-4VTantalum	Titanium 6Al-4VTantalum	Titanium 6Al-4V
Collars	Machined with grooves ortextured to top with grooves	Machined with grooves ortextured to top with grooves	Machined
Thread Pattern	Triple lead threads, patterntightly spaced & equal;partial cylinder type body	Triple lead threads, patterntightly spaced & equal;partial cylinder type body	Single Lead
SurfaceCharacteristics	MTX Surface andTrabecular Metal TM(tantalum)	MTX Surface andTrabecular Metal TM(tantalum)	MTX Surface and MP-1HA

8. Non-Clinical Testing:

Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device. Additionally, torque testing was conducted in accordance with internal Zimmer Research Protocols to indicate the strength at the apical tip of the implant is greater than the stress that the implant will see in dense cortical bone.

ರ. Clinical Testing:

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No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.

1. Conclusion:
  Based on our analysis, the device is substantially equivalent to the predicate.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health.

Public Health Service

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

November 19, 2013

Zimmer Dental Incorporated Dr. Julie Lamothe Manager Regulatory Affairs 1900 Aston Avenue CARLSBAD CA 92008

Re: K132258

Trade/Device Name: Zimmer Dental Trabecular Metal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 18, 2013 Received: October 21, 2013

Dear Dr. Lamothe:

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.

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Page 2 - Dr. Lamothe

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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,

Image /page/5/Picture/6 description: The image shows the text "Kwame O Ulmer for -s FDA". The text is in a simple, sans-serif font. The word "FDA" is stylized with a decorative border.

Erin Keith Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K132258 510(k) Number (if known):

. •

Device Name: Zimmer Dental Trabecular Metal Implant System

Indications For Use:

The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants . when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants . when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional . implants when used in the pre-molar region and should not be used in the molar region.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michae 2013.1

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.