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RetroFix

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200226

by Retrofix Screws, Llc

Identifiers

510(k) Number
K200226 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RetroFix Screw is a cannulated taper screw designed for orthopedic fixation, specifically indicated for distal fibula fractures. It is classified under orthopedic implants and is engineered to provide secure fixation tailored to individual patient anatomy.

This single-use device is supplied sterile and intended for surgical use in orthopedic trauma settings. The RetroFix Screw is authorized under FDA 510(k) clearance (K200226) and is manufactured by RetroFix Screws, LLC in Salisbury, North Carolina. Its design incorporates patented features to enhance stability and adaptability for fracture repair.

Frequently asked questions

What types of fractures is the RetroFix Screw specifically designed to treat, and why is it preferred for those cases?

The RetroFix Screw is specifically designed for distal fibula fractures, a common type of ankle injury. Its cannulated taper design and patented features allow for secure fixation tailored to the unique anatomy of the distal fibula, providing enhanced stability during the healing process. This makes it particularly well-suited for orthopedic trauma settings where precise and adaptable fixation is critical.

Is the RetroFix Screw reusable, or is it intended for single-use only? How does this affect its clinical use?

The RetroFix Screw is explicitly designed for single-use only, which aligns with sterile surgical requirements. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal fixation performance. Reuse is not recommended or supported, as it could compromise sterility and mechanical reliability.

How is the RetroFix Screw supplied, and what should clinicians consider when handling it in the operating room?

The RetroFix Screw is supplied sterile and ready for immediate surgical use. Clinicians should ensure proper handling to maintain sterility, such as using aseptic techniques during unpackaging and adhering to standard surgical protocols for orthopedic implants. The single-use nature also means each package should be inspected for integrity before opening.

What regulatory pathway was followed for FDA clearance of the RetroFix Screw, and what does this mean for its clinical adoption?

The RetroFix Screw received FDA 510(k) clearance (K200226) under the Traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device in the orthopedic category. This means the device was evaluated against existing standards for safety and effectiveness, confirming it meets regulatory requirements for market authorization. Clinicians can rely on this clearance as evidence of its compliance with FDA standards for orthopedic fixation devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Retrofix Screws, LLC, Retrofix Screws, Llc, RetroFix Screws, LLC - LinkedIn, RETROFIX SCREWS, LLC in Salisbury, NC | Company Info & Reviews - Bizapedia, Retrofix Screws, LLC — MedIndexer | MedIndexer

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Retrofix Screws, Llc

Sources (1)

  • FDA 510(k) K200226 24 fields · synced Sep 19, 2026