IMTEC BIOPIN

K982951 · Imtec Corp. · DZL · Jun 21, 1999 · Dental

Device Facts

• Record ID: K982951
• Device Name: IMTEC BIOPIN
• Applicant: Imtec Corp.
• Product Code: DZL · Dental
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.

Device Story

IMTEC BioPin is a bioresorbable fixation pin used in dental surgery to stabilize guided tissue regeneration membranes. Fabricated from a 70/30 copolymer of L-lactide and DL-lactide, the pin features a low-profile, lens-shaped head and a shaft with two circular ribs. It is provided sterile and is manually placed by a clinician at the surgical site to anchor membranes to bone. By providing a resorbable attachment mechanism, the device eliminates the need for a second-stage surgery to remove non-resorbable fixation hardware. The device is intended for prescription use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: PURASORB PL (70/30 copolymer of L-lactide/DL-lactide, MW 152,000). Form factor: Pin with lens-shaped head and two-ribbed shaft. Sterilization: Sterile. Energy source: None (mechanical fixation).

Indications for Use

Indicated for stabilization of bioresorbable guided tissue regeneration membranes in the oral cavity during dental surgery healing. Contraindicated in patients with local infection, vascular impairment, uncontrolled diabetes, chronic high-dose steroid therapy, clotting disorders, anticoagulant therapy, metabolic bone disease, or known allergies to polylactide or lactic acid.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• LEADfix Bioresorbable Membrane Pin (K974392)
• 3I Bioresorbable Fixation Tack (K972480)
• Synthes Fixation System (K974554)

Submission Summary (Full Text)

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K982951

JUN 21 1999

#### 510 (k) SUMMARY

#### SUBMITTED BY:

M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 [phone]

F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407

Date Submitted: August 20,1998

# CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:

Classification Name: Screw, fixation, intraosseous (ref: 21 CFR 8722.4880); Product Code: DZL Common/ Usual Name: Membrane fixation pin.

Proprietary Name: IMTEC BioPin.

#### PREDICATE DEVICE:

LEADfix Bioresorbable Membrane Pin ( K974392) 3I Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554)

### DEVICE DESCRIPTION:

The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The pin provides an anchoring mechanism to resident and adjacent bone at the surgical site. The pin is fabricated from a bioresorable copolymer of L and DL lactide. The pin has a low profile, round, lens shaped head an a shaft with two circular ribs. It is provided in a sterile vial.

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## INDICATIONS FOR USE:

The resorbable IMTEC BioPin pin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment. Its use is intended to avoind a second stage surgery required to remove nonresorbable tacks and pins.

# PRINCIPLES OF OPERATION:

The IMTEC BioPin is a bioresorbable pin used to fix commercially available bioresorbable guided tissue regeneration membranes.

### CONTRAINDICATIONS:

Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include but are not limited to, current local infection, vascular impairment at the surgical site, uncontrolled diabetes, chronic high dose steroid therapy, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which affect bone or wound healing. Specifically if allergies to polylactid and lactic acid is known

### COMPLICATIONS:

Possible complications with any oral reconstructive surgery include infection, closure perforation, abcess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. Specific to this surgery is augmentation material perforation or exfoliation.

# MATERIALS OF CONSTRUCTION:

IMTEC BioPin is molded from PURASORB PL, a 70/30 copolymer of L( - ) Lactide/ DL-Lactide ( Molecular Weight: 152.000) by IMTEC-SWISS, Ardmore, OK.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The design, material, configuration, method of sterilization and other technological characteristics of IMTEC BioPin are similar to the currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 21 1999

M.K. Patterson, Jr., Ph.D. Sr. Vice President Requlatory Affairs IMTEC Corporation 2401 North Commerce P.O. Box 1562 Ardmore, Oklahoma 73402 U.S.A

K982951 Re : IMTEC BioPin Trade Name: Regulatory Class: II Product Code: DZL Dated: March 22, 1999 Received: March 23, 1999

Dear Dr. Patterson:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Federal Reqister.

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Page 2 - Dr. Patterson

this response to your premarket notification Please note: 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 requlation (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,

Timothy A. Ulatowski

Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:IMTEC BioPin

Indications For Use:

The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.

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Concurrance of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K982951 |