ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM

K132258 · Zimmer Dental, Inc. · DZE · Nov 19, 2013 · Dental

Device Facts

• Record ID: K132258
• Device Name: ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
• Applicant: Zimmer Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Endosseous dental implant system; titanium alloy core with Trabecular Metal (tantalum) porous structure; designed for osseointegration via bone ingrowth into 3D tantalum structure. Implant features tapered body, triple-lead threads, and internal hex interface. Used by dental clinicians in clinical settings to replace missing teeth. Implanted into maxilla or mandible; supports immediate or delayed loading. Provides mechanical stability for prosthetic restoration. Benefits include enhanced surface area for osseointegration and mechanical strength comparable to predicate devices.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including fatigue, compression, and torque testing conducted in accordance with FDA guidance for root-form dental implants.

Technological Characteristics

Materials: Titanium 6Al-4V alloy and Tantalum (Trabecular Metal). Design: Tapered body, triple-lead threads, internal hex interface. Surface: MTX surface and Trabecular Metal. Dimensions: 3.7mm diameter; 10mm, 11.5mm, 13mm, 16mm lengths. Mechanical principle: Endosseous root-form fixation with bone ingrowth into porous tantalum structure.

Indications for Use

Indicated for patients requiring replacement of one or more missing teeth in the maxilla or mandible. Suitable for immediate, conventional, or delayed loading. Contraindicated for specific regions based on diameter: 3.7mmD implants must be splinted in pre-molar region and are not for molar use; 4.1mmD implants must be splinted in molar region; 4.1mmD x 8mmL implants must be splinted in pre-molar region and are not for molar use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Trabecular Metal Dental Implant (K112160, K113753)
• Screw Vent Dental Implant (K013227, K061410)

Submission Summary (Full Text)

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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

- 2. 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.

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

NOV 1 9 2013

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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.

#### న్. Indications for Use:

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.

#### 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.

- 7. Technological Characteristics

| Feature | New Device<br>Zimmer Trabecular Metal<br>Implant | Predicate 1<br>Zimmer Trabecular Metal<br>Implant | Predicate 2<br>Screw-Vent Dental<br>Implant |
|----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Implant<br>Interface | Internal Hex | Internal, Hex | Internal Hex |
| Implant Lengths | 10mm, 11.5mm, 13mm,<br>16mm | 8.0mm, 10mm, 11.5mm,<br>13mm, 16mm | 8.0mm, 10mm, 13mm,<br>16mm |
| Implant<br>Diameters | 3.7mm | 4.1mm, 4.7mm, 6.0mm | 3.3mm, 3.7mm, 4.7mm |
| Material | Titanium 6Al-4V<br>Tantalum | Titanium 6Al-4V<br>Tantalum | Titanium 6Al-4V |
| Collars | Machined with grooves or<br>textured to top with grooves | Machined with grooves or<br>textured to top with grooves | Machined |
| Thread Pattern | Triple lead threads, pattern<br>tightly spaced & equal;<br>partial cylinder type body | Triple lead threads, pattern<br>tightly spaced & equal;<br>partial cylinder type body | Single Lead |
| Surface<br>Characteristics | MTX Surface and<br>Trabecular Metal TM<br>(tantalum) | MTX Surface and<br>Trabecular Metal TM<br>(tantalum) | MTX Surface and MP-1<br>HA |

#### 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.

- 10. 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 [phone] or [phone] 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 [phone] or [phone] 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 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.

× 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