510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K092038Substantially Equivalent

Aptus K-Wire System

Medartis AG, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092038 is the FDA 510(k) clearance record for APTUS K-WIRE SYSTEM, a class II device, cleared for Medartis AG on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 67 510(k) clearances for Medartis AG, from to . As of , FDA records show no recalls naming K092038.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Medartis AG 11234 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

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