(65 days)
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.
The provided text is a 510(k) Summary for a medical device (Vazquez-Diner Intraoral Distraction Device). It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from this document. The document explicitly states: "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 (1945500), the Synthes Mini Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272)."
This indicates that clinical studies demonstrating performance against acceptance criteria, as one might find for a novel device, were not a requirement for this specific submission. The FDA clearance process for 510(k) submissions relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical performance studies in many cases.
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K96464/9
JAN 2 4 1997
510(k) Summary
| Device Proprietary Name: | Vazquez-Diner Intraoral Distraction Device |
|---|---|
| Device Common Name: | Mandibular Bone Distractor |
| Classification Name: | Smooth or metallic bone fixation fastener21 CFR 888 3040 |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | Kristyn R. WaskiProduct Engineer, Special ProjectsHowmedica Leibinger Inc.14540 Beltwood Pkwy. EastDallas, TX 75244 |
| Telephone: | (972) 392-3636 x266 |
| Fax: | (972) 392-7258 |
| 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 (1945500), 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
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.