510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192994Substantially Equivalent

Paragon 28 APEX 3D Total Ankle Replacement System

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

K192994 is the FDA 510(k) clearance record for Paragon 28 APEX 3D Total Ankle Replacement System, a class II device, cleared for Paragon 28, Inc. on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 59 510(k) clearances for Paragon 28, Inc., from to . As of , FDA records show no recalls naming K192994.

Clearance record

Decision date
Received
(259 days to decision)
Product code
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3110
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 HSN

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