Cleared Special

TaperSet? Hip System

K252846 · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Orthopedic

Nov 2025

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K252846 is an FDA 510(k) clearance for the TaperSet? Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics (El Dorado Hills, US). The FDA issued a Cleared decision on November 20, 2025, 73 days after receiving the submission on September 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K252846 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2025
Decision Date	November 20, 2025
Days to Decision	73 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358