CUI Articulated Silicone Chin
by Cui Corp. 510(k)
Active
510(k) K903327
Overview
The CUI Articulated Silicone Chin is an internal chin prosthesis designed for reconstructive purposes in plastic surgery. It is classified as a silicone-based implant intended to restore or augment facial contours following trauma, congenital defects, or surgical resection.
This device is supplied as a single-use, sterile implant and is regulated under FDA 510(k) clearance (K903327) under regulation 878.3550. It is intended for use in controlled surgical settings by qualified plastic surgeons and is categorized as a Class II medical device. No additional sterility or MRI safety specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903327 | Date10 Sep 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3550
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cui Corp.
Questions
What is the CUI Articulated Silicone Chin used for in clinical practice?
The CUI Articulated Silicone Chin is specifically designed for reconstructive plastic surgery to restore or augment facial contours after trauma, congenital defects, or surgical resection. It acts as an internal chin prosthesis to help rebuild or enhance the chin’s structure in controlled surgical settings.
Is the CUI Articulated Silicone Chin intended for single-use or can it be reused?
The device is explicitly supplied as a single-use implant. This ensures sterility and safety for each patient, as reuse could compromise integrity and introduce infection risks, particularly in reconstructive procedures.
How is the CUI Articulated Silicone Chin regulated and what does that mean for its use?
The device holds FDA 510(k) clearance (K903327) under regulation 878.3550, classified as a Class II medical device. This means it has undergone review by the FDA’s Subcommittee on Urology (SU) and is deemed substantially equivalent to a predicate device, ensuring it meets safety and effectiveness standards for use by qualified plastic surgeons in surgical settings.
Are there different sizes or models available for the CUI Articulated Silicone Chin?
While the provided data lists multiple registration numbers and product codes (e.g., FWP), it does not specify exact sizes or models. However, the articulated design suggests variability in dimensions to accommodate different patient anatomies. For precise sizing options, consulting the manufacturer’s catalog or surgical planning tools would be necessary.
How should the CUI Articulated Silicone Chin be stored before use?
As a sterile, single-use implant, the device should be stored in its original packaging until ready for use. The packaging is likely designed to maintain sterility, so it should remain unopened and protected from contamination until the surgical procedure begins.