FDA Registration Active 🇨🇭 Switzerland

MEDACTA INTERNATIONAL SA

Reg #: 3005180920 · FEI: 3005180920 · Expires 2026
Products
106
Proprietary Names
283
Establishment Types
6
Classifications
106

Registration Details

Registration Name
MEDACTA INTERNATIONAL SA
Registration Number
3005180920
FEI Number
3005180920
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Strada Regina
City
Castel San Pietro Ticino
Country
CH

Regulatory Submissions

510(k) Number
K234048

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

Proprietary Names

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

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 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor