FDA Product Code OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
Leading manufacturers include Conmed Corporation, Biorez, Inc. and Celestray Biotech Company, LLC.,.
10
Total
10
Cleared
130d
Avg days
2012
Since
Growing category -
4 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
64d
recently vs 174d historically
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon Devices (Product Code OWW)
10 devices
Cleared
Jul 18, 2025
VersaCoat Tendon Protector (VTP-44G2)
Alafair Biosciences
Orthopedic
49d
Cleared
Feb 27, 2025
Rotium
Nanofiber Solutions, LLC
Orthopedic
55d
Cleared
Nov 27, 2024
BioBrace®
Conmed Corporation
Orthopedic
125d
Cleared
Jul 29, 2024
BioBrace® Reinforced Implant
Conmed Corporation
Orthopedic
28d
Cleared
Jun 14, 2024
VersaWrap
Alafair Biosciences, Inc.
Orthopedic
81d
Cleared
Jul 06, 2023
SpinMedix Absorbable Fibrous Membrane
Celestray Biotech Company, LLC.,
Orthopedic
346d
Cleared
May 26, 2023
FlexBand
International Life Sciences
Orthopedic
109d
Cleared
Apr 30, 2021
The BioBrace Implant
Biorez, Inc.
General & Plastic Surgery
176d
About Product Code OWW - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OWW since 2012, with 10 receiving FDA clearance (average review time: 130 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OWW Product Code
Recent submissions under OWW have taken an average of 64 days to reach a decision - down from 174 days historically, suggesting improved FDA processing for this classification.
OWW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →