OWY · Class II · 21 CFR 878.3300

FDA Product Code OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.

Leading manufacturers include Embody, Inc., Smith and Nephew, Inc. and Smith & Nephew Inc., Endoscopy Div..

14
Total
14
Cleared
136d
Avg days
2012
Since
Growing category - 5 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 109d recently vs 151d historically

FDA 510(k) Cleared Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon Devices (Product Code OWY)

14 devices
1–14 of 14
Cleared Sep 30, 2025
Arthrex SpeedFLEX™ Implant
K251690
Arthrex, Inc.
Orthopedic · 120d
Cleared Sep 19, 2025
Tapestry Biointegrative Implant
K252647
Embody, Inc.
Orthopedic · 29d
Cleared Jun 06, 2025
TYBR Collagen Gel
K250109
Tybr Health
Orthopedic · 141d
Cleared Jun 04, 2025
Tendon Protect (50242)
K243843
Kerecis Limited
Orthopedic · 173d
Cleared Nov 26, 2024
REGENETEN™ Bioinductive Implant
K242631
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 84d
Cleared May 11, 2023
Regeneten Bioinductive Implant
K222501
Smith and Nephew, Inc.
Orthopedic · 266d
Cleared May 23, 2022
Tapestry Biointegrative Implant
K220867
Embody, Inc.
Orthopedic · 59d
Cleared Nov 02, 2021
Tapestry Biointegrative Implant
K212306
Embody, Inc.
Orthopedic · 102d
Cleared Oct 19, 2020
TAPESTRY Biointegrative Implant
K201572
Embody, Inc.
Orthopedic · 130d
Cleared Jan 08, 2016
BioBridge Collagen Matrix
K151083
Fibralign Corporation
Orthopedic · 261d
Cleared Mar 26, 2014
COLLAGEN TENDON SHEET-DDI (CTS-DDI)
K140300
Rotation Medical, Inc.
Orthopedic · 48d
Cleared Dec 20, 2013
MESO TENDON MATRIX
K133169
Kensey Nash Corporation Dba Dsm Biomedical
Orthopedic · 64d
Cleared Oct 07, 2013
TRELLIS COLLAGEN RIBBON
K131143
Wrightmedicaltechnologyinc
Orthopedic · 167d
Cleared Nov 08, 2012
MTF FASCIA
K120479
Musculoskeletal Transplant Foundation
Orthopedic · 266d

About Product Code OWY - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code OWY since 2012, with 14 receiving FDA clearance (average review time: 136 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OWY Product Code

Recent submissions under OWY have taken an average of 109 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.

OWY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →