Newfix Screw, Wire and Pin Fixarion System
by Tecnologia Y Diseno Industrial, S.A DE C.V
510(k) K101254
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101254 | Date15 Jul 2010 | 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- Withdrawn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
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Newfix Screw, Wire and Pin Fixation System is an orthopedic fixation device classified under the FDA’s product code HWC. It comprises Kirschner wires, Schanz screws, Steinmann pins, and conical threaded bone screws designed to stabilize bone fractures, facilitate joint fusions, or serve as guide pins for additional implants. These components are engineered from implant-grade stainless steel to ensure biocompatibility and structural integrity within the skeletal system.
This system is intended for use in clinical settings by surgeons, providing mechanical support during bone reconstruction or fracture repair procedures. The components are supplied sterile and are classified as single-use devices, adhering to FDA 510(k) clearance under the Orthopedic advisory committee. Sizes and configurations vary to accommodate different anatomical applications, with no MRI safety restrictions specified. Authorization for market distribution is granted via FDA 510(k) clearance (K101254)
Other devices from Tecnologia Y Diseno Industrial, S.A DE C.V
Questions
AI-generated answers, 1 Oct 2026
What is the Newfix Screw, Wire and Pin Fixation System used for?
The Newfix system is designed to stabilize bone fractures, assist in joint fusions, and serve as guide pins for additional implants. Its components—Kirschner wires, Schanz screws, Steinmann pins, and conical threaded screws—provide mechanical support during orthopedic reconstruction or repair procedures. The system’s modular components allow surgeons to tailor fixation to specific anatomical needs.
How is the Newfix system supplied, and is it reusable?
The Newfix Screw, Wire and Pin Fixation System is supplied sterile and is classified as a single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the implant-grade stainless steel components, which are not intended for reuse.
What sizes and configurations are available for the Newfix system?
The system offers varying sizes and configurations to accommodate different anatomical applications. While exact dimensions are not specified in the provided data, the modular design allows for flexibility in selecting components based on surgical requirements, such as fracture location or joint fusion needs.
Can the Newfix system be used in MRI environments?
The provided data does not specify MRI safety restrictions for the Newfix system. Clinicians should verify compatibility with their MRI equipment and protocols before use, as metallic implants may pose risks in magnetic fields.
What regulatory clearance does the Newfix system hold?
The Newfix Screw, Wire and Pin Fixation System holds FDA 510(k) clearance under the Orthopedic advisory committee, classified as substantially equivalent to predicate devices. This clearance allows for market distribution in the U.S. under the product code HWC, ensuring compliance with FDA standards for orthopedic fixation devices.