510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854205Substantially Equivalent

Kirschner Compression Hip Screw System

Kirschner Medical Corp., Timonium MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854205 is the FDA 510(k) clearance record for KIRSCHNER COMPRESSION HIP SCREW SYSTEM, a class II device, cleared for Kirschner Medical Corp. on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K854205.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Kirschner Medical Corp. 9690 Deereco Rd.D, Timonium MD
Third party review
No

Clearances, product code KTT

Trailing 12 months
9 clearances under product code KTT in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KTT, trailing twelve months
MonthClearances
November 20252
December 20252
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261