DeviceClearance

Primal K-Wire (P99-193-1410)— 510(k) K262722

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K262722 for Primal K-Wire (P99-193-1410), Substantially Equivalent on 2026-08-28. Applicant: Paragon 28, Inc.. Device class: 2.

Summary

Paragon 28 filed the Primal K-Wire, listed as P99-193-1410, under product code HTY, smooth fixation pins. The record has no other description of the wire.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and the submission type is Special.

Paragon 28 filed from Centennial, Colorado. Review took 28 calendar days (July 31 to August 28, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Paragon 28, Inc.
Product code
Product code HTY
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Centennial, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HTY

product code HTY
Injury
544
Total
544

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.