DeviceClearance

APEX 3D S Diamond Tibia— 510(k) K261120

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K261120 for APEX 3D S Diamond Tibia, Substantially Equivalent on 2026-10-07. Applicant: Paragon 28, Inc.. Device class: 2.

Summary

The APEX 3D S Diamond Tibia from Paragon 28 is filed under HSN, semi-constrained cemented metal/polymer ankle prostheses. The name points to a tibial component; the record doesn't say whether other components of the ankle system were part of this submission.

Class II, 21 CFR 888.3110. The Orthopedic panel reviewed it as a Traditional 510(k).

Paragon 28 filed from Englewood, Colorado. Review took 187 days (April 3 to October 7, 2026).

Clearance details

Applicant
Paragon 28, Inc.
Product code
Product code HSN
Device class
Class 2
Regulation
21 CFR 888.3110
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HSN

view all

More clearances from Paragon 28, Inc.

view all

Adverse events under product code HSN

product code HSN
Death
3
Injury
4,711
Total
4,714

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.