Chrysalis Intelligence · Sponsors · Arthrex, Inc.

Arthrex, Inc.

Naples, FL, US · 117 510(k) clearances · 6 recalls

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Total clearances
117
2020-01-10 → 2026-08-07
Last 12 months
19
Product codes
25
Most recent
2026-08-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 26 2026-06-26
HRS Plate, Fixation, Bone Class II Orthopedic 16 2026-03-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Class II Orthopedic 13 2026-08-07
HWC Screw, Fixation, Bone Class II Orthopedic 9 2026-06-25
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 7 2025-10-16
HTN Washer, Bolt Nut Class II Orthopedic 6 2025-12-22
GAT Suture, Nonabsorbable, Synthetic, Polyethylene Class II General, Plastic Surgery 6 2022-10-27
HSB Rod, Fixation, Intramedullary And Accessories Class II Orthopedic 5 2026-03-20
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 5 2023-04-10
QHE — — — 3 2024-10-02
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II Orthopedic 2 2025-07-01
JDQ — — — 2 2025-02-20
JDR Staple, Fixation, Bone Class II Orthopedic 2 2025-01-31
HSD — — — 2 2024-02-12
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Orthopedic 2 2023-09-26
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II Orthopedic 2 2020-11-20
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Class II Orthopedic 1 2026-07-30
OWY — — — 1 2025-09-30
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon Class II General, Plastic Surgery 1 2025-05-29
MRW System, Facet Screw Spinal Device Unclassified Unknown 1 2025-05-22
HRX Arthroscope Class II Orthopedic 1 2025-05-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class II Orthopedic 1 2023-10-18
KNW Instrument, Biopsy Class II Gastroenterology, Urology 1 2021-11-19
HTY — — — 1 2020-06-29
LLZ System, Image Processing, Radiological Class II Radiology 1 2020-04-30
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
2
Most recent
2022-11-02
DateSeverityStatusRecall # ProductCodeReason
2022-11-02 Class II Ongoing 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… — The devices may be packaged with the wrong reamer size.
2022-03-25 Class II Terminated Z-1035-2022 K-Wire, 1.35 mm x 170 mm — Products do not meet length and diameter specifications.
2021-06-14 Class II Ongoing Z-2107-2021 Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC — Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
2021-03-11 Class II Terminated Z-1380-2021 Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and f… — It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
2021-02-24 Class II Terminated Z-1310-2021 Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures. — The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
2020-06-24 Class II Terminated 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… — Screws provided in packaging are 5mm shorter than intended
Filings

All 510(k) clearances (117)

Date K-number Device Code Class Specialty
2026-08-07 K262357 Arthrex Bioabsorbable PushLock Suture Anchors MAI Class II Orthopedic
2026-07-30 K260624 Arthrex Radial Head Replacement System KWI Class II Orthopedic
2026-06-26 K260018 Arthrex FiberButton MBI Class II Orthopedic
2026-06-25 K260809 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System HWC Class II Orthopedic
2026-05-28 K253931 Arthrex Bioabsorbable PushLock Suture Anchors MAI Class II Orthopedic
2026-05-08 K254215 Arthrex Beaming System HWC Class II Orthopedic
2026-03-20 K260561 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2026-03-20 K252016 Arthrex Humeral Nails HSB Class II Orthopedic
2026-03-09 K260405 FiberTape Button MBI Class II Orthopedic
2026-03-05 K252196 Arthrex FibuLock Nail System HSB Class II Orthopedic
2026-03-03 K260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button HRS Class II Orthopedic
2026-03-02 K254229 Arthrex Nano FiberTak Suture Anchor MBI Class II Orthopedic
2026-01-21 K253713 Arthrex Variable Angle (VA) Proximal Tibia Plating System HRS Class II Orthopedic
2026-01-12 K252807 Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates HRS Class II Orthopedic
2025-12-30 K253895 Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm MBI Class II Orthopedic
2025-12-22 K253727 Syndesmosis TightRope PRO HTN Class II Orthopedic
2025-10-29 K252314 Arthrex SutureTak Suture Anchor MBI Class II Orthopedic
2025-10-16 K251994 Arthrex Synergy Vision Imaging System GCJ Class II Gastroenterology, Urology
2025-09-30 K251690 Arthrex SpeedFLEX™ Implant OWY — —
2025-07-18 K251809 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2025-07-10 K251145 Arthrex PushLock Suture Anchors MBI Class II Orthopedic
2025-07-01 K251453 Arthrex iBalance Partial Knee System HSX Class II Orthopedic
2025-05-29 K243480 SuturePatch Tissue Reinforcement OWX Class II General, Plastic Surgery
2025-05-22 K250920 Arthrex Spine Compression FT Screw MRW Unclassified Unknown
2025-05-16 K243602 Arthrex Spine Endoscope HRX Class II Orthopedic
2025-05-05 K250728 Arthrex Synergy Vision Endoscopic Imaging System GCJ Class II Gastroenterology, Urology
2025-03-28 K250596 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2025-03-26 K243995 Arthrex Humeral Plating System and Cerclage Button HRS Class II Orthopedic
2025-03-14 K250526 Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor MAI Class II Orthopedic
2025-03-11 K250424 Arthrex TightRope Soft Button, RT MBI Class II Orthopedic
2025-02-20 K243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures JDQ — —
2025-01-31 K243742 Arthrex DynaNite Nitinol Staples JDR Class II Orthopedic
2025-01-22 K243008 Arthrex NanoScope System GCJ Class II Gastroenterology, Urology
2025-01-13 K243890 Arthrex Intramedullary Nails HSB Class II Orthopedic
2025-01-10 K243195 Arthrex SS VAL and VAL KreuLock™ Compression Screw System HWC Class II Orthopedic
2024-11-14 K242079 Arthrex Elbow Fracture Plating System HRS Class II Orthopedic
2024-10-21 K242554 Arthrex VAL and VAL KreuLock™ Compression Screw System HRS Class II Orthopedic
2024-10-02 K241097 Arthrex Virtual Implant Positioning (VIP) System Software QHE — —
2024-08-31 K241592 Arthrex VAL and VAL KreuLock™ Compression Screw System HWC Class II Orthopedic
2024-07-25 K241361 Arthrex Synergy Vision Endoscopic Imaging System GCJ Class II Gastroenterology, Urology
2024-06-13 K240815 Arthrex Cannulated Screw System HWC Class II Orthopedic
2024-06-04 K233971 Arthrex AlloSync PushLock Suture Anchor MAI Class II Orthopedic
2024-05-29 K241235 Arthrex TightRope II MBI Class II Orthopedic
2024-02-12 K233260 Univers Revers CA Head and Adapter HSD — —
2024-01-18 K233451 Arthrex Synergy Vision Endoscopic Imaging System GCJ Class II Gastroenterology, Urology
2023-11-15 K232973 Arthrex Knee FiberTak® Button Suture Anchor MBI Class II Orthopedic
2023-11-03 K232742 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2023-10-18 K232897 Arthrex Small External Fixation System KTT Class II Orthopedic
2023-10-06 K232755 Arthrex FiberTape and TigerTape Cerclage Sutures HTN Class II Orthopedic
2023-09-26 K230513 Arthrex Univers Apex OptiFit Humeral Stem KWS Class II Orthopedic
2023-09-01 K232340 Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor MBI Class II Orthopedic
2023-08-24 K230976 Arthrex Radiopaque FiberTape Cerclage sutures JDQ — —
2023-08-08 K231857 Arthrex TightRope II MBI Class II Orthopedic
2023-07-17 K230257 Arthrex Intramedullary Nails HSB Class II Orthopedic
2023-06-22 K230904 Arthrex Virtual Implant Positioning (VIP) System QHE — —
2023-06-01 K231330 FiberTak® Suture Anchor MBI Class II Orthopedic
2023-05-18 K231113 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2023-04-10 K230366 Arthrex Univers Revers Monoblock Stem Size 4/33 PHX Class II Orthopedic
2023-04-01 K230568 FiberTak Suture Anchor MBI Class II Orthopedic
2023-03-17 K230435 Arthrex 3.9 mm SwiveLock Anchor MAI Class II Orthopedic
2023-03-10 K230433 Arthrex Knotless FiberTak Suture Anchor MBI Class II Orthopedic
2023-03-08 K222007 Arthrex Virtual Implant Positioning (VIP) System QHE — —
2023-02-02 K223284 SutureLoc™ Implant MBI Class II Orthopedic
2022-12-22 K221396 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2022-12-20 K221031 Arthrex DualCompression Hindfoot Fusion Nail Implant System HSB Class II Orthopedic
2022-10-27 K220880 Arthrex BioSuture GAT Class II General, Plastic Surgery
2022-10-05 K221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II MAI Class II Orthopedic
2022-10-03 K222267 Arthrex 2.4 mm Volar Distal Radius Plate System HRS Class II Orthopedic
2022-09-30 K222244 Arthrex 3.5 mm Locking Compression Plates HRS Class II Orthopedic
2022-09-19 K220839 Arthrex Compression FT Pins HWC Class II Orthopedic
2022-09-14 K222078 Arthrex SoftStitch GAT Class II General, Plastic Surgery
2022-09-09 K221354 Arthrex SutureTape GAT Class II General, Plastic Surgery
2022-08-26 K222263 Arthrex Self Punching SwiveLock Suture Anchors MAI Class II Orthopedic
2022-08-22 K221485 Arthrex FiberTape and TigerTape Cerclage Sutures HTN Class II Orthopedic
2022-08-11 K222161 Arthrex Knotless FiberTak Biceps Suture Anchor MBI Class II Orthopedic
2022-06-29 K220937 Arthrex Mini Fragment System HRS Class II Orthopedic
2022-06-06 K220947 Arthrex Knotless AC Repair Devices HTN Class II Orthopedic
2022-05-19 K221232 Univers Revers Humeral Cup Implant HSD — —
2022-05-13 K221099 Arthrex Self-Punching PushLock Suture Anchor MAI Class II Orthopedic
2022-05-02 K213837 Arthrx Fracture Plates HRS Class II Orthopedic
2021-12-17 K213644 Arthrex Knotless Mini TightRopes HTN Class II Orthopedic
2021-11-19 K213213 Arthrex Vortex Threaded Bone Marrow Recovery Needle KNW Class II Gastroenterology, Urology
2021-11-17 K212415 Arthrex Modular Glenoid System-Titanium Glenosphere PHX Class II Orthopedic
2021-10-25 K212146 Arthrex LoopLoc Knotless Suture GAT Class II General, Plastic Surgery
2021-09-02 K211074 Univers Revers Modular Glenoid System, Standard Augment Baseplates PHX Class II Orthopedic
2021-07-22 K202582 Arthrex SynergyID Endoscopic Imaging System GCJ Class II Gastroenterology, Urology
2021-06-07 K210050 Augmented VaultLock Glenoid KWS Class II Orthopedic
2021-06-01 K210994 Arthrex Beveled FT Screws HWC Class II Orthopedic
2021-04-19 K203495 Arthrex SwiveLock Anchor MAI Class II Orthopedic
2021-03-25 K203834 Arthrex Patella SuturePlates HRS Class II Orthopedic
2021-02-03 K203294 Arthrex Pilon Fusion System HRS Class II Orthopedic
2020-12-30 K203239 Arthrex Low Profile Screws HWC Class II Orthopedic
2020-12-16 K203180 Arthrex DynaNite Nitinol Staples JDR Class II Orthopedic
2020-11-27 K203268 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2020-11-20 K203100 Arthrex Eclipse Titanium Humeral Head PKC Class II Orthopedic
2020-11-18 K202535 Arthrex FastThread Interference Screw MAI Class II Orthopedic
2020-11-17 K202444 Knotless TensionTight Button Implant System MBI Class II Orthopedic
2020-11-04 K202581 Arthrex TightRope II MBI Class II Orthopedic
2020-10-02 K190707 Arthrex SoftStitch GAT Class II General, Plastic Surgery
2020-09-04 K201134 Arthrex NanoScope System GCJ Class II Gastroenterology, Urology
2020-09-03 K201522 Arthrex Syndesmosis TightRope XP Buttress Plate Implant System HTN Class II Orthopedic
2020-09-02 K201677 Arthrex Mesh Plates HRS Class II Orthopedic
2020-08-21 K201749 Arthrex SwiveLock Anchor MAI Class II Orthopedic
2020-08-13 K200895 Univers Revers Modular Glenoid System, Half Augment Baseplate PHX Class II Orthopedic
2020-07-30 K201786 Arthrex Mini Hip PushLock MAI Class II Orthopedic
2020-07-27 K201132 Arthrex Compression Screws HRS Class II Orthopedic
2020-07-24 K193575 Arthrex SutureTape GAT Class II General, Plastic Surgery
2020-07-08 K201542 Arthrex Eclipse Shoulder Prosthesis System PKC Class II Orthopedic
2020-07-08 K193345 Arthrex DynaNite Compression Plate HRS Class II Orthopedic
2020-07-06 K201235 Arthrex MaxForce MTP Compression Plates and Screws HRS Class II Orthopedic
2020-06-29 K200068 Arthrex DynaNite K-Wire HTY — —
2020-04-30 K193523 ArthrexVIP Web Portal LLZ Class II Radiology
2020-03-17 K200433 iBalance UKA Tibial Tray Implant HSX Class II Orthopedic
2020-03-12 K200341 Arthrex FiberTak Suture Anchor MBI Class II Orthopedic
2020-02-10 K193156 Arthrex Mini Comprehensive Fixation System - 1.0mm Screws HWC Class II Orthopedic
2020-01-15 K193503 Arthrex SwiveLock Suture Anchor MAI Class II Orthopedic
2020-01-10 K193372 Univers Revers Modular Glenoid System (Augemented baseplates) PHX Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence