ClearanceBrief
Company · US

Arthrex, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.

355510(k) clearances (19 in 12 months)
28recalls (0 in 12 months)
21recalls that name a 510(k)

Product codes

CodeDeviceRecords
MAIFastener, Fixation, Biodegradable, Soft Tissue53
MBIFastener, Fixation, Nondegradable, Soft Tissue53
HWCScrew, Fixation, Bone48
HRSPlate, Fixation, Bone42
HRXArthroscope27
GATSuture, Nonabsorbable, Synthetic, Polyethylene19
HTNWasher, Bolt Nut17
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented15
HTYPin, Fixation, Smooth13
PHXShoulder Prosthesis, Reverse Configuration11
GCJLaparoscope, General & Plastic Surgery9
HSBRod, Fixation, Intramedullary And Accessories6
JDRStaple, Fixation, Bone6
PLFBone Wedge6
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented5
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer4
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer4
JDQCerclage, Fixation3
QHEShoulder Arthroplasty Implantation System3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2026K262975Arthrex Beaming System
Arthrex, Inc.
HWC
Sep 24, 2026K262618Arthrex Spine Compression FT Screw
Arthrex, Inc.
MRW
Sep 1, 2026K262451Arthrex DynaNite Staples
Arthrex, Inc.
JDR
Aug 7, 2026K262357Arthrex Bioabsorbable PushLock Suture Anchors
Arthrex, Inc.
MAI
Jul 30, 2026K260624Arthrex Radial Head Replacement System
Arthrex, Inc.
KWI
Jun 26, 2026K260018Arthrex FiberButton
Arthrex, Inc.
MBI
Jun 25, 2026K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
HWC
May 28, 2026K253931Arthrex Bioabsorbable PushLock Suture Anchors
Arthrex, Inc.
MAI
May 8, 2026K254215Arthrex Beaming System
Arthrex, Inc.
HWC
Mar 20, 2026K260561Arthrex FiberTak Suture Anchor
Arthrex, Inc.
MBI
Mar 20, 2026K252016Arthrex Humeral Nails
Arthrex, Inc.
HSB
Mar 9, 2026K260405FiberTape Button
Arthrex, Inc.
MBI
Mar 5, 2026K252196Arthrex FibuLock Nail System
Arthrex, Inc.
HSB
Mar 3, 2026K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
Arthrex, Inc.
HRS
Mar 2, 2026K254229Arthrex Nano FiberTak Suture Anchor
Arthrex, Inc.
MBI
Jan 21, 2026K253713Arthrex Variable Angle (VA) Proximal Tibia Plating System
Arthrex, Inc.
HRS
Jan 12, 2026K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
Arthrex, Inc.
HRS
Dec 30, 2025K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
Arthrex, Inc.
MBI
Dec 22, 2025K253727Syndesmosis TightRope PRO
Arthrex, Inc.
HTN
Oct 29, 2025K252314Arthrex SutureTak Suture Anchor
Arthrex, Inc.
MBI
Oct 16, 2025K251994Arthrex Synergy Vision Imaging System
Arthrex, Inc.
GCJ
Sep 30, 2025K251690Arthrex SpeedFLEX™ Implant
Arthrex, Inc.
OWY
Jul 18, 2025K251809Arthrex FiberTak Suture Anchor
Arthrex, Inc.
MBI
Jul 10, 2025K251145Arthrex PushLock Suture Anchors
Arthrex, Inc.
MBI
Jul 1, 2025K251453Arthrex iBalance Partial Knee System
Arthrex, Inc.
HSX
May 29, 2025K243480SuturePatch Tissue Reinforcement
Arthrex, Inc.
OWX
May 22, 2025K250920Arthrex Spine Compression FT Screw
Arthrex, Inc.
MRW
May 16, 2025K243602Arthrex Spine Endoscope
Arthrex, Inc.
HRX
May 5, 2025K250728Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Mar 28, 2025K250596Arthrex FiberTak Suture Anchor
Arthrex, Inc.
MBI
Mar 26, 2025K243995Arthrex Humeral Plating System and Cerclage Button
Arthrex, Inc.
HRS
Mar 14, 2025K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
Arthrex, Inc.
MAI
Mar 11, 2025K250424Arthrex TightRope Soft Button, RT
Arthrex, Inc.
MBI
Feb 20, 2025K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
Arthrex, Inc.
JDQ
Jan 31, 2025K243742Arthrex DynaNite Nitinol Staples
Arthrex, Inc.
JDR
Jan 22, 2025K243008Arthrex NanoScope System
Arthrex, Inc.
GCJ
Jan 13, 2025K243890Arthrex Intramedullary Nails
Arthrex, Inc.
HSB
Jan 10, 2025K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
HWC
Nov 14, 2024K242079Arthrex Elbow Fracture Plating System
Arthrex, Inc.
HRS
Oct 21, 2024K242554Arthrex VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
HRS
Oct 2, 2024K241097Arthrex Virtual Implant Positioning (VIP) System Software
Arthrex, Inc.
QHE
Aug 31, 2024K241592Arthrex VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
HWC
Jul 25, 2024K241361Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Jun 13, 2024K240815Arthrex Cannulated Screw System
Arthrex, Inc.
HWC
Jun 4, 2024K233971Arthrex AlloSync PushLock Suture Anchor
Arthrex, Inc.
MAI
May 29, 2024K241235Arthrex TightRope II
Arthrex, Inc.
MBI
Feb 12, 2024K233260Univers Revers CA Head and Adapter
Arthrex, Inc.
HSD
Jan 18, 2024K233451Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Nov 15, 2023K232973Arthrex Knee FiberTak® Button Suture Anchor
Arthrex, Inc.
MBI
Nov 3, 2023K232742Arthrex FiberTak Suture Anchor
Arthrex, Inc.
MBI

Newest 50 of 355.

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 8, 2022Arthrex, Inc.
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.
Open, Classified		 MDMNone listed
Mar 25, 2022Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Terminated		 LXHNone listed
Jun 14, 2021Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Open, Classified		 MAIK203495
Mar 11, 2021Arthrex, Inc.
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.
Terminated		 HRSK032187
Feb 24, 2021Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Terminated		 HTWNone listed
Jun 24, 2020Arthrex, Inc.
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 fo
Terminated		 HRSK141478
Dec 17, 2019Arthrex, Inc.
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Terminated		 LXHNone listed
Oct 1, 2019Arthrex, Inc.
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 fixati
Terminated		 HWCK141735
Jan 14, 2019Arthrex, Inc.
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 procedur
Terminated		 GFFNone listed
Nov 19, 2018Arthrex, Inc.
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
Open, Classified		 MBIK180118
Sep 13, 2018Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant.
Open, Classified		 HTONone listed
Aug 27, 2018Arthrex, Inc.
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Open, Classified		 HABNone listed
Oct 3, 2017Arthrex, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as
Terminated		 HSXK060670
Mar 24, 2017Arthrex, Inc.
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Mar 24, 2017Arthrex, Inc.
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Terminated		 MAIK101823
Aug 12, 2016Arthrex, Inc.
Arthrex Suture Washer
Terminated		 HTNK043145
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Apr 22, 2016Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Terminated		 PLFK151256
Jan 11, 2016Arthrex, Inc.
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titaniu
Terminated		 HRSK031666
Dec 17, 2015Arthrex, Inc.
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7
Terminated		 JWHK081127
Get alerts for these product codes