FDA Registration Active 🇨🇭 Switzerland

MEDACTA INTERNATIONAL SA

Reg #: 3008110533 · FEI: 3008110533 · Expires 2026
Products
106
Proprietary Names
283
Establishment Types
6
Classifications
106

Registration Details

Registration Name
MEDACTA INTERNATIONAL SA
Registration Number
3008110533
FEI Number
3008110533
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Via Alla Rossa 6
City
Rancate Ticino
Country
CH

Regulatory Submissions

510(k) Number
K021765

Owner / Operator

Firm Name
Medacta International SA
Operator Number
10024526
Address
Strada Regina
City
Castel San Pietro
State
Ticino
Postal Code
6874
Country
CH
Correspondent
Stefano Baj

US Agent

Business Name
Medacta USA
Contact Name
Christopher Lussier
Address
6386 Global Drive, Suite 101
City
Memphis
State
TN
ZIP
38141
Country
US
Phone
901 2033470

Products

Device Name Product Code
Prosthesis, Hip, Cement Restrictor JDK
Retractor GAD
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Hook, Surgical, General & Plastic Surgery GDG
System, Image Processing, Radiological LLZ
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Screw, Fixation, Bone HWC
Instrument, Manual, Surgical, General Use MDM
Wrap, Sterilization FRG
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Shoulder Prosthesis, Reverse Configuration PHX
Pin, Fixation, Smooth HTY
Pin, Fixation, Threaded JDW
Thoracolumbosacral Pedicle Screw System NKB
Appliance, Fixation, Spinal Interlaminal KWP
Appliance, Fixation, Spinal Intervertebral Body KWQ
Mixer, Cement, For Clinical Use JDZ
Bone Cement, Posterior Screw Augmentation PML
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
Rasp, Surgical, General & Plastic Surgery GAC
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Extractor HWB
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Neurological Stereotaxic Instrument HAW
Orthopedic Augmented Reality SBF
Cement Obturator LZN
Bone Cement, Antibiotic MBB
Bone Cement LOD
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Orthopaedic Surgical Planning And Instrument Guides PBF
Pedicle Screw Placement Guide PQC
Sacroiliac Screw Placement Guide QSR
Starter, Bone Screw HWD
Guide, Needle, Surgical GDF
Spinal Channeling Instrument, Vertebroplasty OCJ
Orthosis, Spinal Pedicle Fixation MNI
Orthosis, Spondylolisthesis Spinal Fixation MNH
Cerclage, Fixation JDQ
Posterior Cervical Screw System NKG
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Reamer HTO
Drape, Surgical, Exempt PUI
Motor, Surgical Instrument, Pneumatic Powered GET
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Bur, Surgical, General & Plastic Surgery GFF
Curette HTF
Orthopedic Manual Surgical Instrument LXH
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Washer, Bolt Nut HTN
Sacroiliac Joint Fixation OUR
Shoulder Arthroplasty Implantation System QHE
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Intraoperative Orthopedic Joint Assessment Aid ONN
Screwdriver HXX
Staple, Fixation, Bone JDR
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Orthopedic Stereotaxic Instrument OLO
Osteotome HWM
Curette, Surgical, General Use FZS
Retractor, Self-Retaining, For Neurosurgery GZT
Evacuator, Vapor, Cement Monomer JDY
Stripper, Surgical HRT
Forceps HTD
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Needle, Aspiration And Injection, Disposable GAA
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Clamp HXD
Bit, Drill HTW
Probe HXB
Cannula, Surgical, General & Plastic Surgery GEA
Cement, Bone, Vertebroplasty NDN
Dispenser, Cement KIH
Accessories, Arthroscopic NBH
Tap, Bone HWX
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Impactor HWA
Gauge, Depth HTJ
Tray, Surgical, Instrument FSM
Elevator HTE
Tape, Measuring, Rulers And Calipers FTY
Table, Operating-Room, Mechanical FWX
Guide, Surgical, Instrument FZX
Component, Traction, Non-Invasive KQZ
Filler, Bone Void, Calcium Compound MQV
Passer HWQ
Arthroscope HRX
Punch, Femoral Neck HWP
Posterior Cervical Screw Placement Guide QSD
Retractor, Fiberoptic FDG
Knife, Surgical EMF
Motor, Surgical Instrument, Ac-Powered GEY
Awl HWJ
Sterilizer, Steam FLE
Rongeur HTX

Proprietary Names

BonePrep kit Retractor MectaLock Suture Anchor Extension MectaCer BIOLOX forte Femoral Heads Quadra C stems MyKnee Cutting Blocks Surgical Instrument - Hook Advanced MyHip Planner MectaLIF Anterior Simple GMK - Line Extension FairFix QT Adjustable Button GMK Revision & Hinge Extension - TiNbN Coating GMK Hinge PEEK CF PUSH-IN SUTURE ANCHOR AcTiFlip , GFS Ultimate Hip ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE Sterilization trays Synd-EZ SS DM Converter – TiN coated Mecta-C TiPEEK MectaLIF Transforaminal Versacem and DM HC Liners Humeral Eccentric Reverse Metaphysis Mecta-C Treu GmbH k-wire M.U.S.T Pedicle Screw System Cement mixing system Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System SMS Cementless Stem Rasp Constrained Liner Mecta-C Stand Alone Extension SnugFit Extractor PEEK CF PUSH-IN SUTURE ANCHORS MasterLoc GMK-SPHERE Spherika Femurs and Tibial Trays Plus Mecta-C Cervical Plate Versafitcup CC Trio extension iMNS Medacta Navigation System Coated Hip Implants Image Processing NextARTM Shoulder Platform Mecta-C TiPEEK with titanium markers Mecta-C with titanium markers Medacta Anatomic Shoulder Prosthesis GMK Revision SC Liners Cement Obturator Twist AP Suture Anchors MSS – Monobloc stem Mectacem-X (With Gentamicin) GMK 3D Metal Tibial Tray MyPAO Guides MectaScrew Extension GMK Short Stem GMK Narrow V-LOX TITANIUM SUTURE ANCHOR NextAR™ Spine Platform MySpine Unilateral Guides NextAR™ TKA Platform My Knee PPS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR SLiK Fix Screw Bone screw starter Medacta Shoulder System: Threaded Glenoid Baseplate Intradisk; K-Wire; Renova Spine Kyphoplasty Kirschner Guide M-ARS ACL: Anatomic Ribbon Surgery System GMK Extension OrthoButton CL Spinal Instrument M.U.S.T. Pedicle Screw System Mbrace Cable M.U.S.T. MINI Posterior Cervical Screws System MasterLoc™ Stem: Lateralized Plus Quadra-P Lateralized Glenosphere MectaLock TI Triple Loaded Suture Anchor Knotless AP Suture Anchors FairFix Adjustable Button System Extension M.U.S.T. Midline Cortical (MC) Screw System GMK Full PE Tibial Components GMK Sphere MITI TITANIUM SUTURE ANCHOR Medacta Shoulder System Versafit Cup Double Mobility Family M.U.S.T. Extension MectaLIF Anterior Extension Reamer Shoulder System - TiNbN Coating 9604UK Gaston sleeve Medacta Shoulder System - Reverse Quadra S Stems Medacta Total Hip System Quadra R Stems Quadra H Stems, Quadra C Stems M.U.S.T. Mini Posterior Cervical Screw System MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS IMT Motorized broach Gaston Mectacer Biolox Option Heads M-Vizion Femoral Revision System Extension MiniMAX GMK Total Knee System NextAR™ RSA Platform AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared AMIStem-P Short Neck MyShoulder™ Placement Guides GMK Sphere Tibial Inserts MOTO™ Partial Knee & MOTO PFJ Systems Extension KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY MectaLIF Extension Curette Manual Orthopedic Instruments MectaLIF 3D Metal Surgical Instrument, AC-Powered Medacta Shoulder System Short Humeral Diaphysis MOTO Lateral M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System MyShoulder Planner MOTO PFJ System Mpact Acetabular System MyHip Planner & Verifier Mpact Extension Medacta Versafitcup CC Trio Mpact DM Converter eLIBRA Versafitcup DM Highcross HXUMWPE AMIStem-C MectaCer Biolox Delta Heads AMIS K Long Screwdriver MectaFix CL Fixation Button with Continuous Loop SnugFit All-Suture Anchor MOTO Parital Knee System NextAR™ Spine GFS BTB PowerKnot High Strength Sutures GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella Osteotome M-Vizion Monobloc Mpact 3D Metal Implants Extension - DMLS Technology Carefusion Shadow Line System Vacuum Pump GFS Ultimate GFS Quadra H and R MPACT Extension - Face Changing Liners M.U.S.T. Mini Extension ActiFlip Mpact 3D Metal Implants and Augments 3D Metal Stripper GMK Sphere Revision MectaLIF Anterior Lag Surgical Manual Instrument MectaBone-P Injection System Injector Instrumentation Cortical Fixation Systems MectaScrew PEEK® GMK Hinge, GMK Revision Access kit B-Screw Mpact Constrained Liner Mpact® 3D Metal Implants - DMLS Technology GMK-Femoral Distal Augmentations MOTO Partial Knee System Extension MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides Evolis Total Knee System Mpact Double Mobility System V-LOX PEEK CF SUTURE ANCHOR MectaLIF Anterior Stand-Alone MectaLock PEEK® Suture Anchor Clamp MySpine Pedicle Screw Placement Guides - LP Drill Bit Probe Cannula System MSS - Humeral reverse liners extension TWIST PEEK SUTURE ANCHOR Quadra C Titanium Interference Screw Mpact 3D Metals Augments Meta + Cement PPEK CF INTERFERENCE SCREW Versafitcup CC Trio - Additional Liners Cement Injector M-Vizion Femoral Revision System MectaLIF Anterior Stand Alone MectaLIF Transforaminal TiPEEK M.U.S.T. Combined Set Screws Arthroscopic Instruments FairFix Adjustable Button System Mpres Neck Preserving Stem MasterLoc™ Stem Extension Bone Tap Mfinity Femoral System NextAR Spine MySpine WebPlanner & MyBalance Fastener, Fixation, Nondegradable, Soft Tissue GMK Revision extension Impactor Mectacem-X M.U.S.T. Pedicle Screw Extension and Long Tab Implants Depth Gauge Medacta Bipolar Heads MectaLIF Anterior MectaLIF 3D Metal Anterior M.U.S.T. MINI Posterior Cervical Screws System Extension Surgical Instrument Tray Surgical Instrument - Elevator AMIStem and Quadra - Line Extension MectaTap TI Suture Anchor MectaLIF GRAFT FIXATION SYSTEM 3DMetal Diaphyseal Femoral Cones GMK Total Knee System- Revision MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides MyKnee R Pin Positioners Knotless PEEK and PEEK CF Push-In Suture Anchor Medacta Bone Screws Total Hip Prosthesis System ¿ CoCr Line Extension Ligament Staple MectaLIF TiPEEK General orthopedic instruments 3DMetal Tibial Cones NextAR™ TKA Platform AMIS Table MectaLock Ti Suture Anchor SLiK Anchors MyPAO SA guides Mectaplug PE II Surgical Instrument MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments GMK Resurfacing Patella Size 4 Glenoid Reconstruction System – Full Wedge Baseplate Traction Instrument Glenoid Reconstruction System HS SutureTape MPACT Extension MectaBone-P LV Medacta Total Hip Prosthesis - AMIStem C, Quadra C SN ATLAS MectaBone-G Reverse Shoulder Passer PowerSuture MectaScope System GMK Total Knee System - TiNbN Coating M.U.S.T. Pedicle Screw System - Extension AMIStem H; Quadra S and H Stems Punch MySpine Cervical Guides MyPAO Planning Report X-Twist Biocomposite Suture Anchor GMK Total Knee System - GMK Revision Hybrid Liners M.U.S.T. Pedicle Screw System – Extension SecureFix Meniscus Repair V-lox Titanium Suture Anchors and Miti Suture Anchors MectaLIF Posterior Extension MectaLock All-Suture Anchors NextAR TSA Platform MectaQTH STD Size Wire Case & Tray Awl MySpine Pedicle Screw Placement Guides PAO Cortical Screw Sterilization tray MectaBone-P NextAR Hip Platform MyKnee UNI-ST Rongeur Endo Head GMK Sphere Extension Synd-EZ Ti PULLUP Adjustable Juxtacortical Fixation Device GMK 3D Metal Tibial Tray Extension MyKnee PPS-Pin Positioners GMK Sphere - Kinematic Alignment GMK Sphere & GMK SpheriKA Cementless Mecta-C Stand Alone SnugFit All-Suture Anchor Extension Fairfix Adjustable Button System Titanium Interference Screws X-Twist PEEK Suture Anchor

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Foreign Private Label Distributor Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility