Nextra CH Cannulated Hammertoe System
by Nextremity Solutions, Inc. 2 variants
510(k) K221610
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221610 | Date4 Nov 2022 | 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- Withdrawn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, 18 Sep 2026
The Nextra CH Cannulated Hammertoe System is a surgical orthopedic device classified as a Cannulated Bone Screw and Instrument Set (HWC Product Code). It is designed for interphalangeal repair and fusion of the lesser toes, providing cannulated implants and instruments to facilitate precise targeting and reproducible hammertoe correction procedures.
This system is intended for use in outpatient surgical settings by healthcare professionals. It is supplied as a sterile, single-use device and has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device. The system includes cannulated implants and specialized instruments for small bone reconstruction, adhering to orthopedic surgical standards.
Other devices from Nextremity Solutions, Inc.
Questions
AI-generated answers, 18 Sep 2026
What specific orthopedic procedure is the Nextra CH Cannulated Hammertoe System designed for, and why is cannulation important in this context?
The Nextra CH Cannulated Hammertoe System is designed for interphalangeal repair and fusion of the lesser toes, specifically addressing hammertoe deformities. Cannulation allows for the placement of screws over a guidewire, which improves precision during insertion. This reduces the risk of misalignment and enhances reproducibility of the correction procedure, ensuring better outcomes for the patient.
Is this device intended for use in any particular type of surgical setting, and why does that matter?
Yes, the Nextra CH Cannulated Hammertoe System is explicitly intended for use in outpatient surgical settings. This matters because outpatient procedures are typically shorter, less invasive, and allow patients to recover at home rather than in a hospital. The design aligns with the efficiency and precision required for such settings, supporting faster recovery and reduced healthcare costs.
How is the sterility of the Nextra CH Cannulated Hammertoe System ensured, and what does single-use mean for clinical workflows?
The device is supplied as sterile, meaning it is pre-packaged and ready for immediate use without additional sterilization. As a single-use system, it eliminates the need for reprocessing between patients, reducing the risk of cross-contamination and ensuring consistent performance. Clinically, this simplifies workflows by removing the steps required for cleaning, sterilizing, and inspecting reusable instruments.
What does the FDA 510(k) clearance under the Traditional pathway with a Substantially Equivalent determination mean for clinicians?
The FDA 510(k) clearance under the Traditional pathway indicates that the Nextra CH Cannulated Hammertoe System has been reviewed and deemed substantially equivalent to a previously approved predicate device. For clinicians, this means the device has met regulatory standards for safety and effectiveness, and its performance is expected to align with established practices for hammertoe correction. The classification as Substantially Equivalent provides confidence in its reliability and compliance with orthopedic surgical standards.