Biomet, Inc. FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
OSSTM Orthopedic Salvage System510(k)Jul 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
Taperloc® Complete Hip Stem510(k)May 19, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 19, 2026
Biomet Kirschner Wires (K-Wires)510(k)May 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 22, 2024
StageOne Select Hip Cement Spacer Molds510(k)Dec 28, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 28, 2022
StageOne Shoulder Cement Spacer Molds510(k)Sep 15, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 15, 2022
StageOne Knee Cement Spacer Molds510(k)Sep 2, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 2, 2022
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve510(k)Feb 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 7, 2022
Comprehensive Humeral Fracture Positioning Sleeves510(k)Dec 10, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 10, 2021
A.L.P.S. Clavicle Plating System510(k)Feb 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 19, 2021