Small Bone Nailing System
by Skeletal Dynamics, Inc. 510(k)
Active
510(k) K211439
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211439 | Date30 Sep 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Small Bone Nailing System is an intramedullary nail fixation device designed for the surgical treatment of bone fractures. It is indicated for the fixation of extra-articular fractures of the long bones of the hand, specifically the metacarpals and the proximal phalanges.
This system provides stability for complex fractures, including those involving bone comminution or loss, by utilizing locking compression screws to compress the nail to the endosteal surface. The device is authorized via FDA 510(k) clearance under K211439. It is intended for use in orthopedic surgical settings.
Other devices from Skeletal Dynamics, Inc
Questions
AI-generated answers, 24 Sep 2026
What is the primary clinical indication for the Small Bone Nailing System?
This system is indicated for the surgical treatment and fixation of extra-articular fractures of the long bones in the hand, specifically targeting the metacarpals and the proximal phalanges.
How does this system provide stability for complex bone fractures?
The system utilizes locking compression screws that compress the nail to the endosteal surface. This mechanism provides necessary stability for complex fractures, including those characterized by bone comminution or bone loss.
What is the regulatory status of the Small Bone Nailing System?
The device is authorized via FDA 510(k) clearance under submission number K211439, confirming it has been found substantially equivalent to predicate devices for its intended use in orthopedic surgical settings.