Product Code: OWY FDA class 2 21 CFR 878.3300

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

General, Plastic Surgery

The Mesh, Surgical, Collagen, Orthopaedics, Reinforcement of Tendon is a collagen-based surgical mesh implant used for reinforcement of soft tissue where weakness exists during tendon repair procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWY, with regulation number 878.3300, reviewed under the orthopedic panel within the General, Plastic Surgery specialty, and it carries an implant flag.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: OWY
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251690	Arthrex SpeedFLEX Implant	Sep 30, 2025	Substantially Equivalent	Arthrex, Inc.
K252647	Tapestry Biointegrative Implant	Sep 19, 2025	Substantially Equivalent	Embody, Inc.
K250109	TYBR Collagen Gel	Jun 06, 2025	Substantially Equivalent	Tybr Health
K243843	Tendon Protect (50242)	Jun 04, 2025	Substantially Equivalent	Kerecis Limited
K242631	REGENETEN Bioinductive Implant	Nov 26, 2024	Substantially Equivalent	Smith & Nephew Inc., Endoscopy Div.
K222501	Regeneten Bioinductive Implant	May 11, 2023	Substantially Equivalent	Smith and Nephew, Inc.
K220867	Tapestry Biointegrative Implant	May 23, 2022	Substantially Equivalent	Embody, Inc.
K212306	Tapestry Biointegrative Implant	Nov 02, 2021	Substantially Equivalent	Embody, Inc.
K201572	TAPESTRY Biointegrative Implant	Oct 19, 2020	Substantially Equivalent	Embody, Inc.
K151083	BioBridge Collagen Matrix	Jan 08, 2016	Substantially Equivalent	Fibralign Corporation
K140300	COLLAGEN TENDON SHEET-DDI (CTS-DDI)	Mar 26, 2014	Substantially Equivalent	Rotation Medical, Inc.
K133169	MESO TENDON MATRIX	Dec 20, 2013	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical
K131143	TRELLIS COLLAGEN RIBBON	Oct 07, 2013	Substantially Equivalent	Wrightmedicaltechnologyinc
K120479	MTF FASCIA	Nov 08, 2012	Substantially Equivalent	Musculoskeletal Transplant Foundation