DeviceClearance

Taperloc® Complete Hip Stem— 510(k) K251270

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K251270 for Taperloc® Complete Hip Stem, Substantially Equivalent on 2026-05-19. Applicant: Biomet, Inc.. Device class: 2.

Summary

Biomet's Taperloc Complete Hip Stem is filed under LPH, which the record names "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented".

Class II, 21 CFR 888.3358. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Biomet filed from Warsaw, Indiana. The decision came 390 calendar days after receipt (April 24, 2025 to May 19, 2026).

Clearance details

Applicant
Biomet, Inc.
Product code
Product code LPH
Device class
Class 2
Regulation
21 CFR 888.3358
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPH

product code LPH
Death
73
Injury
31,640
Malfunction
3,358
Other
2
Total
35,073

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.