510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K113556Substantially Equivalent

Wagner Cone Prosthesis System

Zimmer GmbH, Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113556 is the FDA 510(k) clearance record for WAGNER CONE PROSTHESIS SYSTEM, a class II device, cleared for Zimmer GmbH on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 872 510(k) clearances for Zimmer GmbH, from to . As of , FDA records show one recall naming K113556.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer GmbH P.O. Box 708, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZO

Trailing 12 months
9 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20261