OWY

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product code: OWY
Device name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device class: Class 2
21 CFR: 21 CFR 878.3300
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 14

FDA classification definition

For reinforcement of soft tissue where weakness exists in tendon repair.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Last three years. Most recent: 2025-09-30.

Number	Decision date	Applicant	Device name	Summary
K251690	2025-09-30	Arthrex, Inc.	Arthrex SpeedFLEX Implant	PDF
K252647	2025-09-19	Embody, Inc.	Tapestry Biointegrative Implant	FDA
K250109	2025-06-06	Tybr Health	TYBR Collagen Gel	PDF
K243843	2025-06-04	Kerecis Limited	Tendon Protect (50242)	PDF
K242631	2024-11-26	Smith & Nephew Inc., Endoscopy Div.	REGENETEN Bioinductive Implant	FDA

3 summaries are archived here for direct download.

Official FDA classification page: OWY

Classification and pathway per current FDA publications. Data from openFDA (CC0).