THE PRODIGY SYSTEM DENTAL IMPLANTS

K042429 · BioHorizons Implant Systems, Inc. · DZE · Sep 16, 2004 · Dental

Device Facts

• Record ID: K042429
• Device Name: THE PRODIGY SYSTEM DENTAL IMPLANTS
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of The Prodigy System endosseous implants is in the mandible and maxilla for single tooth replacement or as abutments for fixed bridgework and denture retention.

Device Story

Prodigy System consists of machined titanium screw-form dental implants; used for single tooth replacement or as abutments for fixed bridgework and denture retention. Implants are surgically placed in mandible or maxilla by dental professionals. Device acts as artificial root to support prosthetic restorations. Titanium alloy (ASTM F 136) construction; surface treated via tricalcium phosphate blast media or hydroxylapatite coating (ASTM F 1185) to promote osseointegration. System includes various diameters (3.5mm-6mm) and lengths (9mm-15mm). Provides stable foundation for dental prosthetics, improving patient oral function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only. Device relies on substantial equivalence to predicate BioHorizons Maestro System regarding materials, design, and sterilization validation (ANSI/AAMI/ISO 11137).

Technological Characteristics

Materials: Titanium alloy (ASTM F 136); Surface: Tricalcium phosphate blast or hydroxylapatite coating (ASTM F 1185). Form factor: Screw-type endosseous implant. Diameters: 3.5, 4, 5, 6mm; Lengths: 9, 10.5, 12, 15mm. Sterilization: Radiation (ANSI/AAMI/ISO 11137).

Indications for Use

Indicated for patients requiring single tooth replacement or abutments for fixed bridgework and denture retention in the mandible and maxilla.

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

• BioHorizons The Maestro System (K960026, K010458, K020133, K030463)

Submission Summary (Full Text)

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# SEP 1 6 2004

K042429

# 510(k) Summary 21 CFR 807.92

Date: Official Contact: Manufacturer:

September 3, 2004 Winston Greer, Director, QA & RA BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: [phone] Fax: [phone]

## Proprietary Name

The Prodigy System™ Dental Implants

## Common Name

Screw-type Dental Implant

#### Classification Name

Endosseous implants, surgical components, and prosthetic attachments

## Predicate Devices

Predicate devices are BioHorizons The Maestro™ System dental implants, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003.

## Device Description

The Prodigy System dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

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The Prodigy System is a comprehensive system consisting of dental implants and The Prodigy System is a complenensive system is a summary of the proposed catalog
surgical components. The following table provides a summing with surgical components. The following table provide Blast Texturing with item of relefence numbers by Sunaoc troutinent (***
tricalcium phosphate media, or HA - hydroxylapatite coating), implant diameter, and lenath.

| Catalog<br>REF Number | Surface | Diameter<br>(mm) | Length<br>(mm) | Catalog<br>REF Number | Surface | Diameter<br>(mm) | Length<br>(mm) |
|-----------------------|---------|------------------|----------------|-----------------------|---------|------------------|----------------|
| PYH3509 | HA | 3.5 | 9 | PYR3509 | RBT | 3.5 | 9 |
| PYH35105 | | | 10.5 | PYR35105 | | | 10.5 |
| PYH3512 | | | 12 | PYR3512 | | | 12 |
| PYH3515 | | | 15 | PYR3515 | | | 15 |
| PGH4009 | | 4 | 9 | PGR4009 | | 4 | 9 |
| PGH40105 | | | 10.5 | PGR40105 | | | 10.5 |
| PGH4012 | | | 12 | PGR4012 | | | 12 |
| PGH4015 | | | 15 | PGR4015 | | | 15 |
| PBH5009 | HA | 5 | 9 | PBR5009 | RBT | 5 | 9 |
| PBH50105 | | | 10.5 | PBR50105 | | | 10.5 |
| PBH5012 | | | 12 | PBR5012 | | | 12 |
| PBH5015 | | | 15 | PBR5015 | | | 15 |
| PBH6009 | | | 9 | PBR6009 | | | 9 |
| PBH60105 | HA | 6 | 10.5 | PBR60105 | RBT | 6 | 10.5 |
| PBH6012 | | | 12 | PBR6012 | | | 12 |
| PBH6015 | | | 15 | PBR6015 | | | 15 |

# Intended Use

ed USB
The intended use of The Prodigy System endosseous implants is in the humants for The intended use of The Fronty Oystom on on single tooth replacement or as abutments for fixed bridgework and denture retention.

# Technological Characteristics

ological Characteristics
The fundamental scientific technology of the device is identical to the referenced The fundamental solentino toonnology for sprocessing, packaging and sterilization predicate devices: All materials, Jappredicate BioHorizons Maestro System methous remain the Same as for the prodications are substantially endosseous implants. THS Blonbhichter 10 agy to System device which could affect equivalent to all leatures of the products in design, material and intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three wavy lines, which represent the department's mission to promote health and well-being. The seal is simple and recognizable, and it is used on official documents and publications of the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Mr. Winston D. Greer Director, Quality Assurance & Regulatory Affairs Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243

Re: K042429

Trade/Device Name: BioHorizons The Prodigy System™ Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2004 Received: September 8, 2004

Dear Mr. Greer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Greer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Clus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BioHorizons Implant Systems, Inc. Bionzons Implant System™ Special 510(k): Device Modification September 3, 2004

Page 1 of 1

K042429 510(k) Number: _

Device Name: BioHorizons The Prodigy System™ Endosseous Implants

Indications for Use:

The Prodigy System endosseous implants may be used in the mandible and maxilla for fixed The Prodigy System endosseous Implants may be assul in the may be abutments for fixed bridgework and dental retention.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, De 510(k) Number:

× Prescription Use (per 21 CFR 801.109) ાર

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________