510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122395Substantially Equivalent

Depuy Agility Lp Total Ankle Prosthesis

Depuy Orthopaedics Inc., Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122395 is the FDA 510(k) clearance record for DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS, a class II device, cleared for DePuy Orthopaedics, Inc. on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 209 510(k) clearances for DePuy Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K122395.

Clearance record

Decision date
Received
(85 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
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr., Warsaw IN
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