Cleared Traditional

ArTT Augments and Buttresses and Bone Screws

K251718 · Lima Corporate S.P.A. · Orthopedic

Aug 2025

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K251718 is an FDA 510(k) clearance for the ArTT Augments and Buttresses and Bone Screws, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Lima Corporate S.P.A. (Villanova Di San Daniele, IT). The FDA issued a Cleared decision on August 29, 2025, 86 days after receiving the submission on June 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K251718 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2025
Decision Date	August 29, 2025
Days to Decision	86 days
Submission Type	Traditional
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