VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE

K964649 · Howmedica Leibinger, Inc. · JEY · Jan 24, 1997 · Dental

Device Facts

• Record ID: K964649
• Device Name: VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
• Applicant: Howmedica Leibinger, Inc.
• Product Code: JEY · Dental
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This submission describes an intraoral distraction device. It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Device Story

Intraoral mandibular bone distractor; used for distraction osteogenesis. Components: threaded self-drilling fixation pins, distraction frame, distraction rod, key. Pins attach frame to mandible; rod attaches to frame. Physician directs patient on manual rotation of rod via key to apply tension to osteotomy site. Available in 18mm or 28mm distraction lengths. Single-use device. Used in clinical setting; operated by physician/patient under physician guidance. Benefits: controlled mandibular lengthening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: stainless steel. Design: intraoral/subcutaneous fixation system. Components: threaded self-drilling fixation pins, distraction frame, distraction rod, key. Operation: manual mechanical tensioning. Single-use.

Indications for Use

Indicated for patients requiring mandibular distraction osteogenesis, including those with mandibular micrognathia or hemifacial microsomia.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Howmedica Mandibular Bone Lengthener (K945674)
• Wells Johnson Fixation System (K945500)
• Synthes Mini Lengthening Apparatus (K914558)
• Synthes Mandible Distractor (K962272)

Submission Summary (Full Text)

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JAN 24 1997
K964649

# 510(k) Summary

| Device Proprietary Name: | Vazquez-Diner Intraoral Distraction Device |
| --- | --- |
| Device Common Name: | Mandibular Bone Distractor |
| Classification Name: | Smooth or metallic bone fixation fastener
21 CFR 888 3040 |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | Kristyn R. Waski
Product Engineer, Special Projects
Howmedica Leibinger Inc.
14540 Beltwood Pkwy., East
Dallas, TX 75244
Telephone: [phone] x266
Fax: [phone] |
| Date Prepared: | November 19, 1996 |

## Summary:

This submission describes an intraoral distraction device. It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The device consists of three major components: the threaded self drilling fixation pins, the mandibular distraction frame and the distraction rod and key. The pins attach the frame to the mandible. The distraction rod attaches to the frame and is rotated via the key to apply tension to the frame and osteotomy site. Directions regarding distraction are given to the patient by the physician. Frames are available for up to 18 mm or 28 mm of distraction depending upon the condition of the mandible. All components of this device are for single use.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Mandibular Bone Lengthener (K945674), the Wells Johnson Fixation System (K945500), the Synthes Mini Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272). Each of these devices is intended for use as a mandibular bone lengthener and is manufactured from stainless steel. The designs are equivalent in that they include distraction frames which are attached to the mandible by means of fixation pins on either side of the osteotomy. The Howmedica Mandibular Bone Lengthener, the Wells Johnson Fixation System and the Synthes Mini Lengthening Apparatus are each external fixation systems while the Vazquez-Diner Intraoral Distraction Device and the Synthes Mandible Distractor are intraoral/subcutaneous fixation systems. The basic operational principle of distraction osteogenesis through controlled tensioning of the device construct and osteotomy site is similar for each of these devices.

Appendix E