Medical Device Manufacturer · US , Naples , FL

Arthrex, Inc.

344 submissions · 340 cleared · Since 1992
344
Total
340
Cleared
0
Denied

Arthrex, Inc. — FDA 510(k) Submissions

Arthrex, Inc. has submitted 344 FDA 510(k) premarket notifications since 1992, of which 340 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fastener, Fixation, Nondegradable, Soft Tissue, Screw, Fixation, Bone, Fastener, Fixation, Biodegradable, Soft Tissue, Plate, Fixation, Bone, Arthroscope . Use the specialty filter in the sidebar to narrow results.

344 devices
1–25 of 344
FiberTape Button
K260405 · MBI Fastener, Fixation,... · Orthopedic
Mar 2026 28d
Arthrex FibuLock Nail System
K252196 · HSB Rod, Fixation,... · Orthopedic
Mar 2026 234d
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2026 28d
Arthrex Nano FiberTak Suture Anchor
K254229 · MBI Fastener, Fixation,... · Orthopedic
Mar 2026 63d
Arthrex Variable Angle (VA) Proximal Tibia Plating System
K253713 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2026 58d
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2026 131d
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · MBI Fastener, Fixation,... · Orthopedic
Dec 2025 26d
Syndesmosis TightRope PRO
K253727 · HTN Washer, Bolt Nut · Orthopedic
Dec 2025 28d
Arthrex SutureTak Suture Anchor
K252314 · MBI Fastener, Fixation,... · Orthopedic
Oct 2025 96d
Arthrex Synergy Vision Imaging System
K251994 · GCJ Laparoscope, General &... · General & Plastic Surgery
Oct 2025 111d
Arthrex SpeedFLEX? Implant
K251690 · OWY Mesh, Surgical, Collagen,... · Orthopedic
Sep 2025 120d
Arthrex FiberTak Suture Anchor
K251809 · MBI Fastener, Fixation,... · Orthopedic
Jul 2025 36d
Arthrex PushLock Suture Anchors
K251145 · MBI Fastener, Fixation,... · Orthopedic
Jul 2025 87d
Arthrex iBalance Partial Knee System
K251453 · HSX Prosthesis, Knee,... · Orthopedic
Jul 2025 50d
SuturePatch Tissue Reinforcement
K243480 · OWX Mesh, Surgical,... · Orthopedic
May 2025 202d
Arthrex Spine Compression FT Screw
K250920 · MRW System, Facet Screw... · Orthopedic
May 2025 56d
Arthrex Spine Endoscope
K243602 · HRX Arthroscope · Orthopedic
May 2025 176d
Arthrex Synergy Vision Endoscopic Imaging System
K250728 · GCJ Laparoscope, General &... · General & Plastic Surgery
May 2025 55d
Arthrex FiberTak Suture Anchor
K250596 · MBI Fastener, Fixation,... · Orthopedic
Mar 2025 28d
Arthrex Humeral Plating System and Cerclage Button
K243995 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2025 90d
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
K250526 · MAI Fastener, Fixation,... · Orthopedic
Mar 2025 18d
Arthrex TightRope Soft Button, RT
K250424 · MBI Fastener, Fixation,... · Orthopedic
Mar 2025 25d
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
K243344 · JDQ Cerclage, Fixation · Orthopedic
Feb 2025 118d
Arthrex DynaNite Nitinol Staples
K243742 · JDR Staple, Fixation, Bone · Orthopedic
Jan 2025 58d
Arthrex NanoScope System
K243008 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 2025 118d

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