Interlocking Femoral Nailing System
510(k) K912930
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912930 | Date13 Jan 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Interlocking Femoral Nailing System is an orthopedic implant classified as an intramedullary nail (Device Type: HSB). It is designed for the internal fixation of femoral shaft fractures, providing mechanical stability through interlocking screws to secure the nail in place. This system supports both antegrade and retrograde insertion techniques, accommodating a range of fracture patterns in the femur. Its construction allows for load-sharing and alignment correction during the healing process.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K912930) and falls under the Orthopedic Advisory Committee classification. The system includes modular components such as nails and interlocking screws, available in standardized sizes to match femoral anatomy. Storage requires adherence to sterile packaging protocols, and its design ensures compatibility with standard orthopedic surgical procedures. No MRI safety information is specified.
Other devices from Stryker Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Interlocking Femoral Nailing System used for?
This system is designed for internal fixation of femoral shaft fractures. It provides mechanical stability by securing an intramedullary nail in place with interlocking screws, enabling load-sharing and alignment correction during bone healing. The modular design accommodates various fracture patterns and supports both antegrade (from hip to knee) and retrograde (from knee to hip) insertion techniques.
How is the Interlocking Femoral Nailing System supplied and intended for use?
The system is supplied sterile and is intended for single-use only. Each component, including nails and interlocking screws, is packaged separately to maintain sterility until use. This ensures compliance with surgical standards and minimizes infection risk during orthopedic procedures.
What sizes and models are available for the Interlocking Femoral Nailing System?
The system includes standardized modular components tailored to match femoral anatomy. Nails and interlocking screws are available in multiple sizes to fit different patient anatomies and fracture types. The modular design allows for flexibility in surgical planning, ensuring proper fit and stability for each case.
How should the Interlocking Femoral Nailing System be stored?
Storage must adhere to sterile packaging protocols to preserve the device’s sterility. Components should remain in their original, unopened packaging until immediately before use. Proper storage conditions prevent contamination and ensure the system remains ready for sterile surgical environments.
Is MRI safety information provided for this device?
No MRI safety information is specified for the Interlocking Femoral Nailing System. Clinicians should consult additional resources or manufacturer guidelines if MRI imaging is required post-surgery, as metal implants may pose risks in magnetic fields.