Piccolo Composite Nailing System
by Carbofix Orthopedics Ltd 3 variants
510(k) K132774
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132774 | Date3 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K132774
- FDA 510(k) database K111056
Recalls
-
- Terminated Z-1991-2016
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Timeline
- Cleared FDA 510(k) K111056
- Cleared FDA 510(k) K132774
- Recall initiated FDA recalls Z-1991-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSB
- FDA applicant
- CarboFix Orthopedics , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Piccolo Composite Nailing System is an intramedullary nailing device designed for orthopedic fracture fixation. It consists of carbon fiber-reinforced composite nails and associated hardware, intended for stabilization of fractures in the proximal and distal thirds of the femur.
This system is supplied sterile and comprises intramedullary nails with nail caps available in 0, 5, and 10 mm sizes. It is classified under product code HSB and received FDA 510(k) clearance as substantially equivalent under a special review process in the Orthopedic Advisory Committee. The device is intended for single-use applications in orthopedic surgical settings.