Cleared Traditional

Restrata Soft Tissue Reinforcement (STR)

K251224 · Acera Surgical, Inc. · General & Plastic Surgery

Jun 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K251224 is an FDA 510(k) clearance for the Restrata Soft Tissue Reinforcement (STR), a Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXF), submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 20, 2025, 60 days after receiving the submission on April 21, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K251224 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2025
Decision Date	June 20, 2025
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.