510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800144Substantially Equivalent

Femoral Cement Restrictor

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

K800144 is the FDA 510(k) clearance record for FEMORAL CEMENT RESTRICTOR, a class II device, cleared for Biomet, Inc. on under FDA product code JDS (Nail, Fixation, Bone). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show one recall naming K800144.

Clearance record

Decision date
Received
(29 days to decision)
Product code
JDS Nail, Fixation, Bone
Regulation
21 CFR 888.3030
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 JDS

Trailing 12 months

FDA records hold no clearances under product code JDS in the trailing twelve months.

FDA records show no clearances under product code JDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260