Smith & Nephew Circular Fixation System
510(k) K093047
Smith & Nephew Circular Fixation System is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K093047 on 27 Sep 2010, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093047 | Date27 Sep 2010 | StatusActive |
Official records
- FDA 510(k) database K093047
Recalls
-
- Ongoing Z-0245-2022
Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.
Timeline
- Cleared FDA 510(k) K093047
- Recall initiated FDA recalls Z-0245-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KTT
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent