FDA Registration
Active
🇺🇸 United States
ARTHREX, INC.
Reg #: 1220246
·
FEI: 1220246
·
Expires 2026
Products
120
Proprietary Names
198
Establishment Types
2
Classifications
120
Registration Details
- Registration Name
- ARTHREX, INC.
- Registration Number
- 1220246
- FEI Number
- 1220246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112237
Owner / Operator
- Firm Name
- ARTHREX, INC.
- Operator Number
- 1220287
- Address
- 1370 CREEKSIDE BLVD., --
- City
- Naples
- State
- FL
- Postal Code
- 34108
- Country
- US
- Correspondent
- Barry Dietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2011-09-14 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2011-09-14 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2011-09-14 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2017-11-15 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2017-11-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1996-08-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-12-26 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-08-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-08-22 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2025-08-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2003-08-07 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2007-08-23 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2014-01-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2009-04-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-03-26 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2018-04-03 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-04-03 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2018-10-05 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2026-03-27 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2025-11-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-11-26 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2025-01-09 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2024-07-25 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2024-08-29 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-11-26 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-01-14 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-02-23 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2011-01-17 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2011-10-17 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2007-08-23 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2016-02-24 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2016-02-24 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2016-02-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2008-11-26 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-08-30 |
| System, External Fixator (With Metallic Invasive Components) | NDK | Class 2 | Orthopedic | No | 2021-12-20 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2020-12-17 |
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2017-01-25 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2020-04-09 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-11-19 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-05-18 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2003-08-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2001-07-13 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2016-02-25 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2023-10-24 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2020-01-28 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 1994-12-27 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-10-15 |
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2020-06-19 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2022-09-07 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2011-10-17 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2025-11-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-11-19 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2025-11-19 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2021-09-13 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2008-11-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2007-08-23 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2020-12-01 |
| Total Shoulder Arthroplasty System | QHQ | Class 2 | Orthopedic | No | 2020-12-01 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2011-10-17 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2023-05-22 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2021-09-13 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2021-09-13 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2020-12-17 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2007-08-23 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2003-08-07 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2015-12-31 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-06-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2003-08-07 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2024-08-29 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2008-11-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2011-10-17 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2025-01-09 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2010-09-15 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-08-11 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1994-01-27 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2023-08-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1996-08-07 |
| Holder, Camera, Surgical | FXR | Class 1 | General, Plastic Surgery | No | 2025-11-19 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-08-21 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2024-08-29 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2024-08-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2024-08-29 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2026-03-27 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2008-11-26 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2008-11-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-01-09 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2023-12-05 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-09-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-08-23 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2007-08-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-08-11 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2024-05-23 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2023-08-03 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2007-01-31 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2018-02-27 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-05-24 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2021-09-10 |
| Staple, Absorbable | MNU | Class 2 | Orthopedic | No | 2008-11-26 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-13 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2018-07-03 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-05-23 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1994-01-27 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2025-01-09 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2025-05-30 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2025-05-30 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2023-08-03 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2005-12-20 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 1996-08-07 |
| Balance, Analytical | JQO | Class 1 | Clinical Chemistry | No | 2023-08-03 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2010-07-26 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2024-10-15 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-03-28 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2018-01-17 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2017-01-25 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2024-08-29 |
Proprietary Names
Arthrex MicroSuture Anchors
orthopedic manual instrument
Pin, Fixation, Smooth
BIOCOMPOSITE
Dressing, Compression
Elastic bandage
DOUBLE SYRINGE (ACP) SYSTEM
Arthrex PushLock
VARIOUS BURS
Arthrex PCL TightRope
FIBERTAPE
smooth or threaded metallic bone fixation fastener
Arthrex FiberTak Suture Anchors
OPES ELECTRODES AND ACCESSORIES
RF device, blade, hook
ARTHROSCOPY LEG HOLDER
Arthrex SwiveLock Anchors
Suction Lipoplasty Accessories
Camera, Television, Surgical, Without Audio
Mallet
ARTHROSCOPY PUMP
Shoulder joint metal/ polymer semi-constrained cemented prosthesis
Univers Revers Shoulder Prosthesis System
Manual surgical instrument for general use.
ACL TightRope Double Bundle
ACCIN Uni-Knee System
BIO-PIN
Arthrex Tibial GraftBolt
WASHER
SHAVER SYSTEM
General Hospital and Personal Use Miscellaneous Devices
Weight, 2.5 lb (1.1kg)
Protector, Skin Pressure
BIO-CORKSCREW FT
EXTERNAL FIXATOR SYSTEM
COBE Angel Whole Blood Separation System
Instrument, Special Lens, For Endoscope
ACCIN Total Knee System
FiberTak DR
iBalance
Syringe, piston
BI-CORTICAL BIO-POST AND WASHER
Arthrex Low Profile Screws
single/ multiple component metallic bone fixation appliances and accessories
Arthrex Mini TightRopes
Arthrex Small External Fixation System
Adaptor, Holder, Syringe
saw blade
AESCULAP STERILCONTAINER SYSTEM
Arthrex Fracture System
FiberTape
Fiberstick
FiberWire
AOS HUMERAL NAI
Graft Delivery Device with Integrated Stylet
BIOCOMPOSITE SUTURE ANCHORS
Arthrex Univers II Glenoid Components
Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener
Forceps, General & Plastic Surgery
ACCIN Patellofemoral System
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Arthroscope Sheath
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER
PUSHLOCK
HATRIC
CONTINUOUS WAVE III
drill bit
ACL TightRope
SHAVER BLADES
ACCIN Bipolar Head System
BIO-COMPRESSION SCREW
display, cathode-ray tube, medical
Arthrex Graft-Anchor
Laproscopes
UNIVERS SHOULDER
Insufflator 50L FM134
TRIM-IT FAMILY
Arthrex BioSuture
Nonabsorbable poly(ethylene terephthalate) Surgical Suture
Sutter CURIS RF Generator
fixation plate
SHOULDER HOLDER
Apparatus, Traction, Non-Powered
Orthopedic manual surgical instrument, Passer
Arthrex Univers Apex
Metallic Bone Fixation
Biosync Bone wedge
Biosync
Fastener, Fixation, nondegradable, soft tissue
Fracture Plates & Screws
SUPPORT, PATIENT POSITION
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Arthrex Suture
MINI TIGHTROPE
Wrench
Arthrex Fracture Plates and Screws
Single/multiple component metallic bone fixation appliances and accessories
LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
ARTHROERESIS IMPLANT
Arrowhead Mini-Rail Fixator
INTERFERENCE SCREWS
Arthrex Univers II Shoulder Prosthesis
Arthroscope
Bio-Composite SutureTak
Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System
cart, emergency, cardiopulmonary
Stimublast
Arthrex Pushlock
SUTTER ELECTROSURGICAL CABLES
INTERFERENCE SCREW
TENODESIS FAMILY
Arthrex Biocomposite Transfix
elevator, surgical, general & plastic surgery
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi
HUMERAL FRACTURE PLATE
COMPRESSION STAPLE
BIOCOMPOSITE INTERFERENCE SCREW
Arthrex iBalance BiCompartmental Arthroplasty System
Arthrex Plates, Screws, and Staples
Holder, Camera, Surgical
Arthrex iBalance TKA System
Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Arthrex Fracture Plates
Orthopedic Template
RETROBUTTON
Driver, Prosthesis
TAK FAMILY
FIBERWIRE BUTTON REPAIR KIT
UNIVERS FRACTURE
BIO-FASTAK SUTURE ANCHOR
DOLPHIX EXTERNAL FIXATION SYSTEM
TWISTER, WIRE
Arthrex Tibial GraftBolt
Pliers, Surgical
EXTERNAL FIXATION CLAMP 5 MM PIN X9.5MM ROD MODEL 1151-100 EXTERNAL FIXATON CLAMP 9.5MM ROD
40 L HIGH FLOW INSUFFLATOR F108
Viscogel/Viscospray
BIO-BUTTON
Instrument, manual, surgical, general use
Procellera Composite Antibacterial Wound Dressing
Accessories for the SixFix® Hexapod Fixator
BENDER
Arthrex Ankle Fusion Plating System
Catheter, Irrigation
handle, scalpel
knee joint patellofemorotibial polymer/metal/polymer semi-constrained
Arthrex iBalance Patella Implant, Dome
OSTEOTOMY SYSTEM
ORTHOPEDIC MANUAL INSTRUMENTS
VARIOUS INSTRUMENTS
Arthrex Minimally Invasive Ankle Fusion Plate
Arthrex Compression Plates
DISCOSCOPES, CERVICAL ENDOSCOPES
LOW PROFILE PLATE AND SCREW SYSTEM
Univers II
Forceps, Rongeur, Surgical
EXTERNAL FIXATOR ST.A R 90 F4
ANATOEMIC PROSTHESIS
ARTHREX ANATOEMIC P
Arthrex Distal Extremity Plate System
Clamp
Dual Wave Pump
FASTAK SUTURE ANCHOR
MINI BIO-ANCHOR
Accessories, Photographic, For Endoscope (Exclude Light Sources)
UNIVERS II
CORKSCREW ANCHORS
Arthrex BioComposite SutureTak
BIO-POST AND WASHER
fixation pin
Table Attachments, Operating-Room
OSTEOTOMY PLATE
PARS Needle
Mini TightRope CMC
hook, bone
PROSTOP PLUS
Arthrex Knotless SutureTak Anchor
Loop, wire
FINGERSHIELD
Component, Traction, Non-Invasive
MENISCAL DART, DARTSTICK,
CHONDRAL DART
PROWICK
VARIOUS IMPLANTS
Balance, Analytical
Arthroscopes
System, Digital Image Communications, Radiological
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
CONTAINER SYSTEM
Arthrex PushLock Tenodesis Anchor
Drape, Surgical, Exempt
MENISCAL CINCH
Arthrex Univers CA Heads
Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis
Camera Heads
SHORT LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Source, Carrier, Fiberoptic Light
BIO-ABSORBABLE CORKSCREW
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device