510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182878Substantially Equivalent

Integra Salto Total Ankle System

Ascension Orthopedics, Inc., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182878 is the FDA 510(k) clearance record for Integra Salto Total Ankle System, a class II device, cleared for Ascension Orthopedics on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 29 510(k) clearances for Ascension Orthopedics, from to . As of , FDA records show 8 recalls naming K182878.

Clearance record

Decision date
Received
(64 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
Ascension Orthopedics 11101 Metric Blvd., Austin TX
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