510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K954555Substantially Equivalent

Versa-Fx Femoral Fixation System

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954555 is the FDA 510(k) clearance record for VERSA-FX FEMORAL FIXATION SYSTEM, a class II device, cleared for Zimmer, Inc. on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show one recall naming K954555.

Clearance record

Decision date
Received
(116 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
Zimmer, Inc. P.O. Box 708, Warsaw IN
510(k) summary
Summary
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