Arthrex GmbH
Naples, FL, US
ARTHREX GMBH appears in FDA device records in Naples, FL. FDA records list 352 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 28 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 352FDA records hold 352 510(k) clearances for Arthrex GmbH between 1992 and 2026. The busiest year on record is 2020, with 26. The most recent is 2026, with 14.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 16 |
| 1994 | 10 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 4 |
| 2001 | 10 |
| 2002 | 7 |
| 2003 | 6 |
| 2004 | 9 |
| 2005 | 14 |
| 2006 | 11 |
| 2007 | 8 |
| 2008 | 4 |
| 2009 | 6 |
| 2010 | 6 |
| 2011 | 11 |
| 2012 | 7 |
| 2013 | 10 |
| 2014 | 12 |
| 2015 | 13 |
| 2016 | 11 |
| 2017 | 10 |
| 2018 | 16 |
| 2019 | 19 |
| 2020 | 26 |
| 2021 | 11 |
| 2022 | 17 |
| 2023 | 18 |
| 2024 | 10 |
| 2025 | 21 |
| 2026 | 14 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | Substantially Equivalent | |
| K260624 | Arthrex Radial Head Replacement System | KWI | Substantially Equivalent | |
| K260018 | Arthrex FiberButton | MBI | Substantially Equivalent | |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | HWC | Substantially Equivalent | |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | MAI | Substantially Equivalent | |
| K254215 | Arthrex Beaming System | HWC | Substantially Equivalent | |
| K260561 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | |
| K252016 | Arthrex Humeral Nails | HSB | Substantially Equivalent | |
| K260405 | FiberTape Button | MBI | Substantially Equivalent | |
| K252196 | Arthrex FibuLock Nail System | HSB | Substantially Equivalent | |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | HRS | Substantially Equivalent | |
| K254229 | Arthrex Nano FiberTak Suture Anchor | MBI | Substantially Equivalent | |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | HRS | Substantially Equivalent | |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | HRS | Substantially Equivalent | |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | MBI | Substantially Equivalent | |
| K253727 | Syndesmosis TightRope PRO | HTN | Substantially Equivalent | |
| K252314 | Arthrex SutureTak Suture Anchor | MBI | Substantially Equivalent | |
| K251994 | Arthrex Synergy Vision Imaging System | GCJ | Substantially Equivalent | |
| K251690 | Arthrex SpeedFLEX™ Implant | OWY | Substantially Equivalent | |
| K251809 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | |
| K251145 | Arthrex PushLock Suture Anchors | MBI | Substantially Equivalent | |
| K251453 | Arthrex iBalance Partial Knee System | HSX | Substantially Equivalent | |
| K243480 | SuturePatch Tissue Reinforcement | OWX | Substantially Equivalent | |
| K250920 | Arthrex Spine Compression FT Screw | MRW | Substantially Equivalent | |
| K243602 | Arthrex Spine Endoscope | HRX | Substantially Equivalent | |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | |
| K250596 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | HRS | Substantially Equivalent | |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | MAI | Substantially Equivalent | |
| K250424 | Arthrex TightRope Soft Button, RT | MBI | Substantially Equivalent | |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | JDQ | Substantially Equivalent | |
| K243742 | Arthrex DynaNite Nitinol Staples | JDR | Substantially Equivalent | |
| K243008 | Arthrex NanoScope System | GCJ | Substantially Equivalent | |
| K243890 | Arthrex Intramedullary Nails | HSB | Substantially Equivalent | |
| K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | HWC | Substantially Equivalent | |
| K242079 | Arthrex Elbow Fracture Plating System | HRS | Substantially Equivalent | |
| K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | HRS | Substantially Equivalent | |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | QHE | Substantially Equivalent | |
| K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | HWC | Substantially Equivalent | |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | |
| K240815 | Arthrex Cannulated Screw System | HWC | Substantially Equivalent | |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | MAI | Substantially Equivalent | |
| K241235 | Arthrex TightRope II | MBI | Substantially Equivalent | |
| K233260 | Univers Revers CA Head and Adapter | HSD | Substantially Equivalent | |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | |
| K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | |
| K232742 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | |
| K232897 | Arthrex Small External Fixation System | KTT | Substantially Equivalent | |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | KWS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007193505 | 3007193505 | ARTHREX GMBH | Oskar-von-Miller Strasse 6, Odelzhausen Bavaria 85235 DE | 2026 | and 6 more, listed in full below |
| 1220246 | 1220246 | ARTHREX, INC. | 1370 Creekside Blvd, Naples, FL 34108 US | 2026 | and 111 more, listed in full below |
| 3002579136 | 3002579136 | Arthrex GmbH | Erwin-Hielscher-Strasse 9, Munich Bavaria 81249 DE | 2026 | and 55 more, listed in full below |
| 3010331645 | 3010331645 | Arthrex, Inc. | 6875 Arthrex Commerce Drive, Ave Maria, FL 34142 US | 2026 | and 94 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- HSTApparatus, Traction, Non-Powered
- HRXArthroscope
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GESBlade, Scalpel
- GFFBur, Surgical, General & Plastic Surgery
- FWLCamera, Cine, Endoscopic, Without Audio
- FWBCamera, Television, Surgical, Without Audio
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- GBXCatheter, Irrigation
- EBWController, Foot, Handpiece And Cord
- HNWDilator, Lachrymal
- DXJDisplay, Cathode-Ray Tube, Medical
- FRODressing, Wound, Drug
- HWRDriver, Prosthesis
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FZWExpander, Surgical, Skin Graft
- HTDForceps
- GENForceps, General & Plastic Surgery
- EMHForceps, Rongeur, Surgical
- HTJGauge, Depth
- GDZHandle, Scalpel
- FXRHolder, Camera, Surgical
- HTZInstrument, Cutting, Orthopedic
- FEIInstrument, Special Lens, For Endoscope
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- FSTLight, Surgical, Fiberoptic
- FTLMesh, Surgical, Polymeric
- GABNeedle, Suturing, Disposable
- FWZOperating Room Accessories Table Tray
- HWQPasser
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- FMPProtector, Skin Pressure
- HTOReamer
- HSBRod, Fixation, Intramedullary And Accessories
- HABSaw, Powered, And Accessories
- HWCScrew, Fixation, Bone
- EQHSource, Carrier, Fiberoptic Light
- FLESterilizer, Steam
- CCXSupport, Patient Position
- GAPSuture, Nonabsorbable, Silk
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- BWNTable And Attachments, Operating-Room
- HWTTemplate
- FSMTray, Surgical, Instrument
- GAZTubing, Noninvasive
- HTNWasher, Bolt Nut
- FRGWrap, Sterilization
- HXCWrench
Recall records
Showing 25 of 28| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | The devices may be packaged with the wrong reamer size. | Class II | Open, Classified | |
| Z-1035-2022 | K-Wire, 1.35 mm x 170 mm | Products do not meet length and diameter specifications. | Class II | Terminated | |
| 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. | Class II | Open, Classified | |
| 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. | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | 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. | 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 stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions. | Screws provided in packaging are 5mm shorter than intended | Class II | Terminated | |
| Z-0919-2020 | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide | There is a potential for blockage of the Hub Attachment Tube. | Class II | Terminated | |
| 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. | Screws provided in the device package are 6 mm longer than intended. | Class II | Terminated | |
| 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. | Devices may generate excessive heat during use. | Class II | Terminated | |
| 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 | Potentially lead to anchor breakage during insertion, | Class II | Open, Classified | |
| Z-0442-2019 | 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. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire. | There is potential to break during use. | Class II | Open, Classified | |
| Z-0295-2019 | 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. | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress. | Class II | Open, Classified | |
| Z-0095-2018 | 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 a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis. | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box. | Class II | Terminated | |
| Z-2046-2017 | Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2045-2017 | Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2044-2017 | Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2043-2017 | Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2042-2017 | Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2041-2017 | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II | Terminated | |
| Z-2918-2016 | Arthrex Suture Washer | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. | Class III | Terminated | |
| Z-1963-2016 | 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. | Potential for polystyrene particulate presence. | Class II | Terminated | |
| Z-1962-2016 | 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. | Potential for polystyrene particulate presence. | Class II | Terminated | |
| Z-1961-2016 | 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. | Potential for polystyrene particulate presence. | Class II | Terminated | |
| Z-1960-2016 | 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. | Potential for polystyrene particulate presence. | Class II | Terminated | |
| Z-1959-2016 | 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. | Potential for polystyrene particulate presence. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain