EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES

K961719 · Howmedica Leibinger, Inc. · HRS · Jul 17, 1997 · Orthopedic

Device Facts

• Record ID: K961719
• Device Name: EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
• Applicant: Howmedica Leibinger, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples: - Ear prostheses - Orbital prostheses - Nose prostheses - Cheek prostheses - Hair Pieces Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.

Device Story

Epitec Titanium Implant System provides surgical anchoring for craniofacial prostheses. Device consists of titanium implants used to secure external prosthetic devices (ear, nose, orbital, cheek, hair pieces) to the craniofacial skeleton. Used by surgeons in clinical settings for alloplastic reconstruction following trauma, tumor resection, or genetic anomaly correction. Provides stable attachment point for external prosthetics; improves patient aesthetic and functional outcomes by securing reconstructive devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium implant system; designed for surgical anchoring of craniofacial prostheses. Material: Titanium.

Indications for Use

Indicated for patients requiring fixation of craniofacial prostheses (ear, orbital, nose, cheek, hair pieces) due to genetic anomalies, tumor resections, trauma, or other conditions requiring surgical anchoring.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Kristyn R. Waski
QA/RA Engineer
Howmedica Leibinger Inc.
Pfizer Hospital Products Group
14540 Beltwood Parkway East
Dallas, Texas 75244

JUL 17 1997

Re: K961719
Trade Name: Epitec™ Titanium Implant System
Regulatory Class: II
Product Code: HRS
Dated: May 14, 1997
Received: May 15, 1997

Dear Ms. Waski

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the

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Page 2 - Ms. Kristyn R. Waski

Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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K961719

510(k) Number (if known): not known

Device Name: Epitec™ Titanium Implant System

Indications for Use:

The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples:

- Ear prostheses
- Orbital prostheses
- Nose prostheses
- Cheek prostheses
- Hair Pieces

Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑

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Over-The-Counter Use ☐

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