510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183228Substantially Equivalent

HammerToe Compression System

Paragon 28, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183228 is the FDA 510(k) clearance record for HammerToe Compression System, a class II device, cleared for Paragon 28, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 59 510(k) clearances for Paragon 28, Inc., from to . As of , FDA records show no recalls naming K183228.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Paragon 28, Inc. 4b Inverness Ct. E, Suite 280, Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260