Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
General, Plastic Surgery · 21 CFR 878.3300
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- International Life SciencesOpen, ClassifiedMar 11, 2026
Artelon FlexBand Dynamic Matrix
Augmentation devices failed bacterial endotoxin testing.
Z-1554-2026 · View FDA record ↗ - International Life SciencesOpen, ClassifiedMar 11, 2026
Artelon FlexBand Plus
Augmentation devices failed bacterial endotoxin testing.
Z-1555-2026 · View FDA record ↗ - International Life SciencesOpen, ClassifiedMar 11, 2026
Artelon FLEXBAND TWIST .12
Augmentation devices failed bacterial endotoxin testing.
Z-1556-2026 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Artelon
ATL, GA, US
Boylston Surgical Llc
Osterville, MA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Viant Medical, Inc.
Grand Rapids, MI, US
Allosource
Centennial, CO, US
Linvatec Corporation
LARGO, FL, US
Conmed Corporation
Utica, NY, US
Alafair Biosciences, Inc.
Austin, TX, US
Conmed Corporation
New Haven, CT, US
International Life Sciences
Sandy Springs, GA, US
Geistlich Pharma Ag
WOLHUSEN Luzern, CH
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Steris Schweiz Ag
Daniken Solothurn, CH
Andersen Scientific, Inc.
Morrisville, NC, US
510(k) clearances
10 clearances for this product code
- Alafair BiosciencesJul 18, 2025
K251655 · VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
- Nanofiber Solutions, LLCFeb 27, 2025
K250021 · Rotium
- Conmed CorporationNov 27, 2024
K242187 · BioBrace®
- Conmed CorporationJul 29, 2024
K241906 · BioBrace® Reinforced Implant
- Alafair Biosciences, Inc.Jun 14, 2024
K240817 · VersaWrap
- Celestray Biotech Company, LLC.,Jul 6, 2023
K222220 · SpinMedix Absorbable Fibrous Membrane
- International Life SciencesMay 26, 2023
K230316 · FlexBand; FlexPatch; FlexBand Plus
- Biorez, Inc.Apr 30, 2021
K203267 · The BioBrace Implant