Arthrex, Inc.
Arthrex, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2026, with 28 FDA device recalls on record.
Top product codes for Arthrex, Inc.
FDA recalls by Arthrex, Inc.
10 most recent of 28- Z-0465-2023 — Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
- Z-1035-2022 — K-Wire, 1.35 mm x 170 mm
- Z-2107-2021 — Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- Z-1380-2021 — Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
- Z-1310-2021 — Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
- Z-2733-2020 — Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
- Z-0919-2020 — Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
- Z-1510-2020 — Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
- Z-1206-2019 — Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
- Z-0724-2019 — Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Arthrex, Inc.
1–100 of 353- K262451 — Arthrex DynaNite Staples
- K262357 — Arthrex Bioabsorbable PushLock Suture Anchors
- K260624 — Arthrex Radial Head Replacement System
- K260018 — Arthrex FiberButton
- K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System
- K253931 — Arthrex Bioabsorbable PushLock Suture Anchors
- K254215 — Arthrex Beaming System
- K252016 — Arthrex Humeral Nails
- K260561 — Arthrex FiberTak Suture Anchor
- K260405 — FiberTape Button
- K252196 — Arthrex FibuLock Nail System
- K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
- K254229 — Arthrex Nano FiberTak Suture Anchor
- K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System
- K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
- K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
- K253727 — Syndesmosis TightRope PRO
- K252314 — Arthrex SutureTak Suture Anchor
- K251994 — Arthrex Synergy Vision Imaging System
- K251690 — Arthrex SpeedFLEX Implant
- K251809 — Arthrex FiberTak Suture Anchor
- K251145 — Arthrex PushLock Suture Anchors
- K251453 — Arthrex iBalance Partial Knee System
- K243480 — SuturePatch Tissue Reinforcement
- K250920 — Arthrex Spine Compression FT Screw
- K243602 — Arthrex Spine Endoscope
- K250728 — Arthrex Synergy Vision Endoscopic Imaging System
- K250596 — Arthrex FiberTak Suture Anchor
- K243995 — Arthrex Humeral Plating System and Cerclage Button
- K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
- K250424 — Arthrex TightRope Soft Button, RT
- K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
- K243742 — Arthrex DynaNite Nitinol Staples
- K243008 — Arthrex NanoScope System
- K243890 — Arthrex Intramedullary Nails
- K243195 — Arthrex SS VAL and VAL KreuLock Compression Screw System
- K242079 — Arthrex Elbow Fracture Plating System
- K242554 — Arthrex VAL and VAL KreuLock Compression Screw System
- K241097 — Arthrex Virtual Implant Positioning (VIP) System Software
- K241592 — Arthrex VAL and VAL KreuLock Compression Screw System
- K241361 — Arthrex Synergy Vision Endoscopic Imaging System
- K240815 — Arthrex Cannulated Screw System
- K233971 — Arthrex AlloSync PushLock Suture Anchor
- K241235 — Arthrex TightRope II
- K233260 — Univers Revers CA Head and Adapter
- K233451 — Arthrex Synergy Vision Endoscopic Imaging System
- K232973 — Arthrex Knee FiberTak® Button Suture Anchor
- K232742 — Arthrex FiberTak Suture Anchor
- K232897 — Arthrex Small External Fixation System
- K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures
- K230513 — Arthrex Univers Apex OptiFit Humeral Stem
- K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
- K230976 — Arthrex Radiopaque FiberTape Cerclage sutures
- K231857 — Arthrex TightRope II
- K230257 — Arthrex Intramedullary Nails
- K230904 — Arthrex Virtual Implant Positioning (VIP) System
- K231330 — FiberTak® Suture Anchor
- K231113 — Arthrex FiberTak Suture Anchor
- K230366 — Arthrex Univers Revers Monoblock Stem Size 4/33
- K230568 — FiberTak Suture Anchor
- K230435 — Arthrex 3.9 mm SwiveLock Anchor
- K230433 — Arthrex Knotless FiberTak Suture Anchor
- K222007 — Arthrex Virtual Implant Positioning (VIP) System
- K223284 — SutureLoc Implant
- K221396 — Arthrex FiberTak Suture Anchor
- K221031 — Arthrex DualCompression Hindfoot Fusion Nail Implant System
- K220880 — Arthrex BioSuture
- K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
- K222267 — Arthrex 2.4 mm Volar Distal Radius Plate System
- K222244 — Arthrex 3.5 mm Locking Compression Plates
- K220839 — Arthrex Compression FT Pins
- K222078 — Arthrex SoftStitch
- K221354 — Arthrex SutureTape
- K222263 — Arthrex Self Punching SwiveLock Suture Anchors
- K221485 — Arthrex FiberTape and TigerTape Cerclage Sutures
- K222161 — Arthrex Knotless FiberTak Biceps Suture Anchor
- K220937 — Arthrex Mini Fragment System
- K220947 — Arthrex Knotless AC Repair Devices
- K221232 — Univers Revers Humeral Cup Implant
- K221099 — Arthrex Self-Punching PushLock Suture Anchor
- K213837 — Arthrx Fracture Plates
- K213644 — Arthrex Knotless Mini TightRopes
- K213213 — Arthrex Vortex Threaded Bone Marrow Recovery Needle
- K212415 — Arthrex Modular Glenoid System-Titanium Glenosphere
- K212146 — Arthrex LoopLoc Knotless Suture
- K211074 — Univers Revers Modular Glenoid System, Standard Augment Baseplates
- K202582 — Arthrex SynergyID Endoscopic Imaging System
- K210050 — Augmented VaultLock Glenoid
- K210994 — Arthrex Beveled FT Screws
- K203495 — Arthrex SwiveLock Anchor
- K203834 — Arthrex Patella SuturePlates
- K203294 — Arthrex Pilon Fusion System
- K203239 — Arthrex Low Profile Screws
- K203180 — Arthrex DynaNite Nitinol Staples
- K203268 — Arthrex FiberTak Suture Anchor
- K203100 — Arthrex Eclipse Titanium Humeral Head
- K202535 — Arthrex FastThread Interference Screw
- K202444 — Knotless TensionTight Button Implant System
- K202581 — Arthrex TightRope II
- K190707 — Arthrex SoftStitch
Data sourced from openFDA. This site is unofficial and independent of the FDA.