510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811738Substantially Equivalent

Collarless Tapered Stem Hip Prosth. Dev

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

K811738 is the FDA 510(k) clearance record for COLLARLESS TAPERED STEM HIP PROSTH. DEV, a class II device, cleared for Biomet, Inc. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K811738.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260