DeviceClearance

Megalodon Dynamic Compression System— 510(k) K261121

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K261121 for Megalodon Dynamic Compression System, Substantially Equivalent on 2026-08-06. Applicant: Paragon 28, Inc.. Device class: 2.

Summary

Paragon 28's Megalodon Dynamic Compression System is filed under product code JDR, bone fixation staples. The record gives no sizes or model numbers.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Paragon 28 filed from Centennial, Colorado. The decision came 125 calendar days after receipt (April 3 to August 6, 2026), and it was substantially equivalent.

Clearance details

Applicant
Paragon 28, Inc.
Product code
Product code JDR
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Centennial, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JDR

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More clearances from Paragon 28, Inc.

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Adverse events under product code JDR

product code JDR
Injury
726
Malfunction
663
Other
1
Total
1,390

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.