LEIBINGER IMF SCREW

K963030 · Howmedica Leibinger, Inc. · DZE · Apr 11, 1997 · Dental

Device Facts

• Record ID: K963030
• Device Name: LEIBINGER IMF SCREW
• Applicant: Howmedica Leibinger, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.

Device Story

Leibinger IMF Screw is a 2.0 mm diameter small bone screw (10.5-18.5 mm length) featuring a hole in the screw head for wire passage; used for temporary maxillomandibular fixation to stabilize maxilla/mandible fractures. Device is single-use; implanted by surgeons in clinical settings. Operational principle involves mechanical fixation of bone segments via screw insertion and wire attachment, providing indirect stabilization similar to traditional arch bars or cortical screws. Benefits include simplified fixation compared to traditional methods.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Commercially pure titanium or Ti(6Al-4V). Dimensions: 2.0 mm diameter, 10.5-18.5 mm total length. Design: Small bone screw with a hole in the head for wire fixation. Single-use. Mechanical fixation principle.

Indications for Use

Indicated for temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both in patients requiring fracture stabilization.

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

• Unisplint Dental Arch Bar (K820944)
• Synthes Minihook and Cortical Screw (K# Unknown)
• Synthes Cortical Bone Screw (K912932)
• Leibinger®-Luhr® Small Mandibular Bone Screws (K963740)

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

JUN 2 - 2005

Mr. Andrew B. Rogers
Director, Product Development and Special Projects
Howmedica Leibinger, Incorporated
14540 Beltwood Parkway East
Dallas, Texas 75244

Re: K963030
Trade/Device Name: Leibinger IMF Screw
Regulation Number: 872.3640
Regulation Name: Endosseous dental implant
Regulatory Class: II
Product Code: DZE
Dated: March 12, 1997
Received: March 13, 1997

Dear Mr. Rogers:

This letter corrects our substantially equivalent letter of March 12, 1997 regarding the incorrect product code of Leibinger IMF Screw.

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 (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 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- Mr. Rogers

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 continue 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 yours,

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

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K963030
APR 11 1997

# 510(k) Summary

| Device Proprietary Name: | Leibinger® IMF Screw |
| --- | --- |
| Device Common Name: | Small Bone Screw |
| Classification Name: | Intraosseous Fixation Screw or Wire
21 CFR 872.4880
76 DZL |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | Kristyn R. Waski
QA/RA Engineer
Howmedica Leibinger Inc.
14540 Beltwood Pkwy., East
Dallas, TX 75244
Telephone: [phone] x266
Fax: [phone] |
| Date Prepared: | March 12, 1997 |

## Summary:

This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both. The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Unisplint Dental Arch Bar (K820944); the Synthes Minihook and Cortical Screw (K# Unknown); the Synthes Cortical Bone Screw (K912932); and the Leibinger®-Luhr® Small Mandibular Bone Screws (K963740). The Dental Arch Bars, Minihook and Cortical Screw and Cortical Bone Screw are intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. The Leibinger® IMF Screw and the Synthes Cortical Bone Screw can both be manufactured from commercially pure titanium; the Leibinger® IMF Screw and the Leibinger®-Luhr® Small Mandibular Bone Screws can both be manufactured from Ti(6Al.4V). The basic operational principle is similar for the cortical screw and arch bar devices.

Appendix D