Cleared Special

Tapestry Biointegrative Implant

K252647 · Embody, Inc. · Orthopedic

Sep 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K252647 is an FDA 510(k) clearance for the Tapestry Biointegrative Implant, a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Embody, Inc. (Norfolk, US). The FDA issued a Cleared decision on September 19, 2025, 29 days after receiving the submission on August 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K252647 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2025
Decision Date	September 19, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.