Prelude III Tongue Suspension System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110127 FDA 510(k)
- FDA Product Code
- ORY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prelude III Tongue Suspension System is a dental device classified as a Tongue Suspension System, designed to advance the tongue base anteriorly. It consists of a bone screw threaded with suture, intended for surgical placement to address positional obstruction in the oropharyngeal airway. This device is intended for use in patients with mild or moderate obstructive sleep apnea (OSA) or snoring, though its regulatory classification does not define clinical indications. The system is engineered to provide mechanical support to the tongue, promoting an open airway during sleep.
The Prelude III Tongue Suspension System is supplied as a sterile, single-use device for surgical implantation by qualified dental or maxillofacial professionals. It is regulated under FDA 510(k) clearance (K110127) as a Class II device under regulation number 872.5570, with a special review designation. The system includes multiple registration numbers (e.g., 3008792120, 3013564228) and is intended for use in controlled clinical settings. Storage and handling must comply with sterile surgical protocols to ensure device integrity prior to implantation.
Frequently asked questions
What is the Prelude III Tongue Suspension System used for?
The Prelude III Tongue Suspension System is designed to address positional obstruction in the oropharyngeal airway by advancing the tongue base anteriorly. It is intended for patients with mild or moderate obstructive sleep apnea (OSA) or snoring, though its regulatory classification does not define specific clinical indications. The device provides mechanical support to the tongue, helping maintain an open airway during sleep.
How is the Prelude III Tongue Suspension System supplied and prepared for use?
The Prelude III Tongue Suspension System is supplied as a sterile, single-use device. It must be implanted surgically by qualified dental or maxillofacial professionals. Prior to implantation, the device must be handled and stored according to sterile surgical protocols to ensure its integrity and functionality.
Is the Prelude III Tongue Suspension System reusable or single-use?
The Prelude III Tongue Suspension System is explicitly designed for single-use only. This ensures sterility and safety for each patient, as reuse could compromise device integrity and increase infection risks. Always follow manufacturer guidelines for proper disposal after a single surgical implantation.
What regulatory approval does the Prelude III Tongue Suspension System hold?
The Prelude III Tongue Suspension System holds FDA 510(k) clearance (K110127) as a Class II device under regulation number 872.5570. It was granted a special review designation by the FDA’s Dental Advisory Committee (DE). The device is also registered under multiple FEI numbers (e.g., 3008792120, 3013564228) for traceability and compliance.
How should the Prelude III Tongue Suspension System be stored before use?
The Prelude III Tongue Suspension System must be stored in accordance with sterile surgical protocols to maintain its integrity. This includes keeping it in its original packaging, protected from contamination, and adhering to the manufacturer’s storage instructions. Improper storage could compromise sterility and device performance prior to implantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRELUDE III TONGUE SUSPENSION SYSTEM by SIESTA MEDICAL, INC. | FDA 510 ..., Siesta Medical, Inc., Prelude Tongue Suspension System (K101060) — Fda ..., PDF C> -. 4eL - Food and Drug Administration, PDF PRELUDE III TONGUE SUSPENSION SYSTEM 510(k) K110127 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110127 | Class II | Active |
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Manufacturer
- Manufacturer
- Siesta Medical, Inc.
Sources (1)
- FDA 510(k) K110127 24 fields · synced Oct 1, 2026