510(k) K251270

Taperloc® Complete Hip Stem by Biomet, Inc. — Product Code LPH

K251270 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "Taperloc® Complete Hip Stem". The FDA issued a decision of Substantially Equivalent on May 19, 2026. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Biomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2026
Date Received
April 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type