# DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260995 |
| Device | DynaNail Helix® Fixation System |
| Applicant | MedShape, Inc. |
| Specialty / panel | Orthopedic |
| Product code | HWC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-26 |
| Decision date | 2026-09-23 |
| Review time (days) | 181 |
| Third-party review | No |
| Applicant location | Atlanta, GA, US |

## Why this score
- 181-day review, longer than typical.
- Posted 42 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260995). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.