Cleared Special

Legend? Acetabular Shell

K242833 · Ortho Development Corp. · Orthopedic

Oct 2024

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K242833 is an FDA 510(k) clearance for the Legend? Acetabular Shell, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 11, 2024, 22 days after receiving the submission on September 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K242833 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	October 11, 2024
Days to Decision	22 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