Cleared Abbreviated

OsteoSinter? EVANS and COTTON wedges and related accessories

K240461 · Ames Medical Prosthetic Solutions, S.A.U. · Orthopedic

Dec 2024

Decision

294d

Days

Class 2

Risk

About This 510(k) Submission

K240461 is an FDA 510(k) clearance for the OsteoSinter? EVANS and COTTON wedges and related accessories, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by Ames Medical Prosthetic Solutions, S.A.U. (Sant Feliu De Llobregat, ES). The FDA issued a Cleared decision on December 6, 2024, 294 days after receiving the submission on February 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K240461 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2024
Decision Date	December 06, 2024
Days to Decision	294 days
Submission Type	Abbreviated
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLF — Bone Wedge
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.