SYNTHES MANDIBLE DISTRACTOR

K962272 · Synthes (Usa) · MQN · Aug 30, 1996 · Dental

Device Facts

• Record ID: K962272
• Device Name: SYNTHES MANDIBLE DISTRACTOR
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Aug 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

Device Story

Subcutaneous bone distractor; two telescoping components activated by jack screw; fixed to mandible via subcutaneous plates using 2.0 mm or 2.4 mm bone screws. Operated by surgeon using hex driver. Procedure: osteotomy/corticotomy performed; device fixated across site; latency period (~7 days) followed by activation (~1 mm/day) until desired distraction achieved; device removed after bone consolidation. Used in clinical setting to correct mandibular deficiencies or post-traumatic defects.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Subcutaneous bone distractor; telescoping components; jack screw mechanism; 2.0 mm or 2.4 mm bone screw fixation; mechanical operation via hex driver.

Indications for Use

Indicated for patients requiring gradual bone distraction of the mandible due to mandibular deficiency or post-traumatic effects.

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’s Hoffmann® Mini-Lengthening Fixator (K792561)

Reference Devices

• Howmedica’s Mandibular Bone Distractor (K945674)

Submission Summary (Full Text)

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SYNTHES
K962272
AUG 30 1996

Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]

| Synthes (USA) | Contact: Angela Silvestri |
| --- | --- |
| 1690 Russell Road | [phone] |
| Paoli, PA 19301 | June 1996 |

Synthes Mandible Distractor is compared to the Howmedica’s Hoffmann® Mini-Lengthening Fixator (K792561). The device is similar to Howmedica’s Mandibular Bone Distractor (K945674).

The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mm or 2.4 mm bone screws. A hex driver is used to activate the required distraction.

It is anticipated that the Mandible Distractor will be used as follows:

1. An osteotomy or corticotomy (depending on surgeon preference) is made on the desired section of the mandible.
2. The distraction device is fixated to the bone using 2.0 mm or 2.4 mm screws on both sides of the osteotomy. The fixation portion of the device is subcutaneous.
3. After a latency period of approximately 7 days (the exact time required is determined by the surgeon) the device is activated and distraction begins at a rate of approximately 1 mm/day (the exact rate of distraction is determined by the surgeon).
4. After the desired amount of distraction occurs the device is left until the adequate bone structure has been achieved and the device is removed.

It is our opinion that Synthes Mandible Distractor is substantially equivalent to Howmedica’s Hoffmann® Mini-Lengthening Fixator based on mechanical test results.