Identifiers
- 510(k) Number
- K974365 FDA 510(k)
- FDA Product Code
- ETB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3450 FDA 510(k)
- Regulation Number
- 874.3450 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mills Incus HA Sleeve is a Prosthesis, Partial Ossicular Replacement, classified under FDA regulation 874.3450. This device is designed to reconstruct gaps in the ossicular chain, specifically addressing erosion of the incus in the middle ear. Constructed from hydroxylapatite, it functions as a passive mechanical implant to restore conductive hearing pathways without requiring active power or software.
Surgically implanted by an otolaryngologist (ENT surgeon), the Mills Incus HA Sleeve is intended for use in reconstructive procedures within the middle ear. It is supplied sterile and intended for single-use, with no noted MRI safety restrictions. The device is authorized under FDA 510(k) clearance (K974365) and falls under product code ETB. Storage and handling must comply with sterile surgical instrument protocols.
Frequently asked questions
What is the Mills Incus HA Sleeve designed to treat?
The Mills Incus HA Sleeve is specifically engineered to reconstruct gaps in the ossicular chain caused by erosion of the incus in the middle ear. By acting as a passive mechanical implant, it helps restore conductive hearing pathways without requiring active power or software. This makes it ideal for patients with incus-related hearing impairments where surgical intervention is needed.
How is the Mills Incus HA Sleeve supplied and prepared for use?
The device is supplied sterile and intended for single-use only. It adheres to standard sterile surgical instrument protocols, ensuring it is ready for immediate implantation by an otolaryngologist (ENT surgeon) without additional sterilization steps. This minimizes contamination risks and ensures patient safety during reconstructive procedures.
Is the Mills Incus HA Sleeve safe for use in MRI environments?
There are no noted MRI safety restrictions for the Mills Incus HA Sleeve. However, as with any implanted device, clinicians should always verify compatibility with their specific MRI machine settings and protocols before proceeding. This ensures optimal imaging outcomes and patient safety during diagnostic procedures.
What materials is the Mills Incus HA Sleeve made from?
The implant is constructed from hydroxylapatite, a biocompatible ceramic material commonly used in medical devices for its ability to integrate with bone and provide structural support. This material choice ensures durability and stability within the middle ear environment while maintaining compatibility with surrounding tissues.
How should the Mills Incus HA Sleeve be stored before use?
The device must be stored in accordance with sterile surgical instrument protocols to maintain its integrity and sterility. This includes proper packaging, protection from contamination, and adherence to manufacturer guidelines for shelf life. Always check the packaging for expiration dates or storage conditions before use to ensure optimal performance during surgery.
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: MILLS INCUS HA SLEEVE (K974365) — FDA 510(k) | Innolitics, K974365 FDA 510 (k) - MILLS INCUS HA SLEEVE, MILLS INCUS HA SLEEVE 510 (k) K974365 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974365 | Class II | Active |
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Manufacturer
- Manufacturer
- Exmoor Plastics , Ltd.
Sources (1)
- FDA 510(k) K974365 24 fields · synced Oct 1, 2026