DeviceClearance

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro— 510(k) K254110

Substantially Equivalent

MedShape, Inc.

FDA 510(k) clearance K254110 for DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro, Substantially Equivalent on 2026-03-18. Applicant: MedShape, Inc.. Device class: 2.

Summary

MedShape's record lists seven names: DynaNail Mini, DynaNail Hybrid, DynaNail Helix, DynaClip, DynaClip Forte, DynaClip Delta and DynaClip Quattro. All are filed under HWC, bone fixation screws.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

MedShape filed from Atlanta, Georgia. Review took 89 calendar days (December 19, 2025 to March 18, 2026).

Clearance details

Applicant
MedShape, Inc.
Product code
Product code HWC
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Atlanta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.