ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX

K080074 · Ace Surgical Supply Co., Inc. · DZE · Feb 14, 2008 · Dental

Device Facts

• Record ID: K080074
• Device Name: ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
• Applicant: Ace Surgical Supply Co., Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 14, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Device Story

ACE Tru-FIX™ Implant System consists of machined surgical-grade titanium alloy (Ti-6AL-4V ELI) screws used to stabilize bone grafts or fractured bone segments in oral and maxillofacial surgery. The system is used in clinical settings by surgeons to secure bone plates or titanium mesh. The screws provide mechanical fixation to support bone healing and reconstruction. The device is supplied sterile in various sizes and includes placement instruments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Ti-6AL-4V ELI titanium alloy per ASTM F136. Form factor: Machined endosseous screws. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for stabilization and support of bone grafts and/or fractured bone segments in oral and maxillofacial site defects, with or without the use of bone plates or titanium mesh.

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

• ACE Surgical Miniboneplate system (K951392)
• ACE Surgical Orthodontic Screw System (K061397)

Submission Summary (Full Text)

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K080074

## 510(k) Summary of Safety and Effectiveness

his summary of 510(k) safety and effectiveness information is being submitted in accordance in
ternation in mants of SMDA 1990 and 21 CFR 807.92. his summary of 510(K) Salety and encettiveness imonmal
oth the requirements of SMDA 1990 and 21 CFR 807.92.

- Submitter Name: Submitter Address hone Number: ax Number: Date Prepared Device Trade Name: Device Common Name: assification Name: redicate devi
ACE Surgical Supply Co., Inc. 1034 Pearl St , Brockton, MA 02301 J. Edward Carchidi, DDS [phone] [phone] January, 2008 ACE Tru-FIX™ Implant System Endosseous Implant Screw Endosseous, Root form, product code DZE ACE Surgical Miniboneplate system, K951392 ACE Surgical Minibonopiato of Screw System, K061397 Not previously marketed in the USA

FEB 14

eason for submission:

Device Description and Materials: Description and Materials:
The ACE Tru-FIX™ Implant System is a set of machined surgical grade titanium alloy (Ti-OAL-AV ELI) he ACE Tru-FIX ™ implant System is as to machined of fical grado staman me respents with on without bone
crews, intended to stabilize and support bone graft and or fractured ows, intended to stablize and support bother grants are some ognied sterile in 3.0 mm
Mes or titlanium mesh in oral and maxillofacial site defects. The implied sterile in 3 lates of titanium mesh in oral maxilolabal site delector. The Impans and 15 mm, in standard tray packaging d include placement instruments.

e screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in the screw raw material is 11-6-AL-4 CLI per ASTMTF 150 startails are most and connection
werels and characteristics to that cleared under K951392. These screws are supplie vek™ trays.

a ACE Surgical TRU-Fix ™ Implant System is a comprehensive system retaining prostheits components, if ACE Surgical TRU-Fix '''' Implant System is a compronents of Jordinal Miniboneplate system.

## tended Use:

nemed Use.
The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and of fractured e segments with or without bone plates or titanium mesh in oral and maxillofacial site defects

## obstantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Ovice(s):

wice(s):
ACE Surgical TRU-Fix™ Implant System is substantially equivalent to the ACE Surgical Orthodontic The Screw System, K061397 and ACE Surgical Screw Miniboneplate System, K951392

mong the information and data presented in the 510(k) submission to supsential equivalency. e ACE Surgical TRU-Fix™ Implant System to the specifical redicate devices are: 1) device description, the bench test results, 4) materials, and 5) labeling. In particular, the bench testing the ACE andidn's for use, 3) benefit test results, 17 materials, and by is effectiveness between the ACE Cal TRU-Fix™ Implant System and the specified predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 14 2008

J. Edward Carchidi, DDS President ACE Surgical Supply Company, Incorporated 1034 Pearl Street Brockton, Massachusetts 02301

Re: K080074

Trade/Device Name: ACE Tru-FIX™ Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 11, 2008 Received: February 12, 2008

Dear Dr. Carchidi:

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 - Dr. Carchidi

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 (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.

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/industry/support/index.html.

Sincerely yours,

Suytte Y. M. Arum Duis

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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## Indications for Use

Number:

Name: ACE Tru-FIX™ Implant System 0

dications For Use:

Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or ed bone segments with or without bone plates or titanium mesh in oral and maxillofacial

iption Use × CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k080074

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