Identifiers
- 510(k) Number
- K183236 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rotium Bioresorbable Wick is a biodegradable fastener used for soft tissue fixation in orthopedic applications. It is classified as a medical device under device class 2 and is identified by the product code MAI.
The device received FDA 510(k) clearance (K183236) on March 11, 2019, and is substantially equivalent to a predicate device. It is manufactured by Nanofiber Solutions, LLC in Hilliard, Ohio, and is regulated under regulation number 888.3030.
Frequently asked questions
What is the Rotium Bioresorbable Wick used for?
The Rotium Bioresorbable Wick is a biodegradable fastener designed for soft tissue fixation in orthopedic applications, providing temporary support that is absorbed by the body over time.
How is the Rotium Bioresorbable Wick supplied and is it sterile?
The device data does not specify the supply format or sterility status of the Rotium Bioresorbable Wick; therefore, sterility and packaging details cannot be confirmed from the provided information.
Is the Rotium Bioresorbable Wick intended for single use or reuse?
As a biodegradable fastener for soft tissue fixation, the Rotium Bioresorbable Wick is intended for single use, as it is designed to be implanted and absorbed, not retrieved or reused.
What regulatory pathway was used for the Rotium Bioresorbable Wick?
The Rotium Bioresorbable Wick received FDA 510(k) clearance under submission K183236 on March 11, 2019, and was determined to be substantially equivalent to a predicate device.
What are the available sizes or models of the Rotium Bioresorbable Wick?
The device data does not list specific sizes, models, or reference numbers for the Rotium Bioresorbable Wick beyond the product name and product code MAI; therefore, size or model variations cannot be determined from the provided information.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183236 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanofiber Solutions Llc
- FDA Applicant
- Nanofiber Solutions, LLC
Sources (1)
- FDA 510(k) K183236 24 fields · synced Sep 23, 2026