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Medacta International S.A.

Castel San Pietro (Ch), CH · 100 510(k) clearances

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Total clearances
100
2020-01-06 → 2026-05-05
Last 12 months
11
Product codes
32
Most recent
2026-05-05
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II Orthopedic 13 2025-09-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 11 2025-07-01
SBF Orthopedic Augmented Reality Class II Neurology 10 2026-01-09
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 7 2026-02-03
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II Orthopedic 7 2023-06-09
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 5 2026-04-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 5 2026-01-28
LLZ System, Image Processing, Radiological Class II Radiology 5 2025-04-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 3 2026-05-05
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II Orthopedic 3 2026-02-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 3 2025-07-17
NKG Posterior Cervical Screw System Class II Orthopedic 3 2022-04-26
PBF Orthopaedic Surgical Planning And Instrument Guides Class II Orthopedic 2 2025-11-19
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II Orthopedic 2 2025-07-24
PQC — — — 2 2023-07-21
HWC Screw, Fixation, Bone Class II Orthopedic 2 2022-02-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 2 2020-11-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene Class II General, Plastic Surgery 1 2025-09-12
KWZ — — — 1 2025-07-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class II Orthopedic 1 2025-06-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Orthopedic 1 2025-01-30
PML Bone Cement, Posterior Screw Augmentation Class II Orthopedic 1 2024-06-12
JDQ — — — 1 2024-05-03
QSD Posterior Cervical Screw Placement Guide Class II Orthopedic 1 2023-12-07
QSR Sacroiliac Screw Placement Guide Class II Orthopedic 1 2022-05-24
JDR Staple, Fixation, Bone Class II Orthopedic 1 2021-04-12
JDK Prosthesis, Hip, Cement Restrictor Class II General, Plastic Surgery 1 2021-04-08
KRO — — — 1 2021-03-02
MAI Fastener, Fixation, Biodegradable, Soft Tissue Class II Orthopedic 1 2021-02-22
OUR Sacroiliac Joint Fixation Class II Orthopedic 1 2021-01-13
HRX Arthroscope Class II Orthopedic 1 2020-10-01
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class II Orthopedic 1 2020-04-20
Filings

All 510(k) clearances (100)

Date K-number Device Code Class Specialty
2026-05-05 K254202 MectaLIF 3D Metal Anterior OVD Class II Orthopedic
2026-04-28 K253940 M.U.S.T. Pedicle Screw System - Extension NKB Class II Orthopedic
2026-02-26 K253328 GMK 3D Metal Tibial Tray Extension MBH Class II Orthopedic
2026-02-03 K250644 MSS - Monobloc stem PHX Class II Orthopedic
2026-01-28 K251043 Mpact 3D Metal Implants Extension – DMLS Technology LPH Class II Orthopedic
2026-01-09 K252847 NextAR Hip Platform SBF Class II Neurology
2025-11-19 K242603 MyPAO SA guides PBF Class II Orthopedic
2025-10-31 K250338 MSS - Humeral reverse liners extension PHX Class II Orthopedic
2025-09-19 K250450 Coated hip implants LZO Class II Orthopedic
2025-09-12 K252225 PowerKnot High Strength Sutures GAT Class II General, Plastic Surgery
2025-09-04 K251737 NextAR(TM) Shoulder Platform SBF Class II Neurology
2025-07-31 K250477 NextAR(TM) Spine SBF Class II Neurology
2025-07-31 K241461 Mpact Constrained Liner KWZ — —
2025-07-24 K251618 MOTO Partial Knee System Extension HSX Class II Orthopedic
2025-07-17 K251016 MectaLIF 3D Metal MAX Class II Orthopedic
2025-07-01 K251933 SnugFit ASA Extension MBI Class II Orthopedic
2025-06-13 K251166 Mfinity Femoral System MEH Class II Orthopedic
2025-04-23 K243697 MySpine WebPlanner LLZ Class II Radiology
2025-04-23 K242232 Mpact 3D Metal Augments II LPH Class II Orthopedic
2025-03-06 K241767 Versacem Acetabular Shell and Double Mobility HC Liners LZO Class II Orthopedic
2025-01-30 K241292 MyShoulder Planner (5.3SSWPL) KWS Class II Orthopedic
2024-06-12 K241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System PML Class II Orthopedic
2024-05-03 K232733 Mbrace Cable JDQ — —
2024-04-24 K233172 NextAR™ Spine Platform SBF Class II Neurology
2024-02-13 K234048 M.U.S.T. Pedicle Screw System - Extension NKB Class II Orthopedic
2023-12-07 K231515 MySpine Cervical Guides QSD Class II Orthopedic
2023-11-09 K231911 Glenoid Reconstruction System – Full Wedge Baseplate PHX Class II Orthopedic
2023-10-29 K232280 NextAR™ TSA Platform SBF Class II Neurology
2023-10-18 K232123 MectaLIF Anterior Lag Extension OVD Class II Orthopedic
2023-09-20 K230011 Mpact Extension LPH Class II Orthopedic
2023-07-21 K231483 MySpine Unilateral Guides PQC — —
2023-07-21 K223769 NextAR™ Spine Platform SBF Class II Neurology
2023-06-09 K231037 MyKnee UNI-ST JWH Class II Orthopedic
2023-05-30 K220706 MyPAO Guides PBF Class II Orthopedic
2023-04-17 K230544 SnugFit All-Suture Anchor extension MBI Class II Orthopedic
2023-02-24 K223582 MectaLock TI Triple Loaded Suture Anchor MBI Class II Orthopedic
2023-01-20 K223548 GMK Sphere & GMK SpheriKA Cementless MBH Class II Orthopedic
2023-01-20 K221725 Advanced MyHip Planner LLZ Class II Radiology
2023-01-17 K223795 FairFix QT Adjustable Button MBI Class II Orthopedic
2022-11-23 K213459 Glenoid Reconstruction System PHX Class II Orthopedic
2022-10-24 K221545 MectaLIF Anterior Extension OVD Class II Orthopedic
2022-08-23 K221850 GMK 3D Metal Tibial Tray MBH Class II Orthopedic
2022-08-16 K222169 FairFix Adjustable Button System MBI Class II Orthopedic
2022-07-22 K211891 DM Converter - TiN coated LZO Class II Orthopedic
2022-06-08 K221389 FairFix AM Adjustable Button FairFix PSP Adjustable Button MBI Class II Orthopedic
2022-05-24 K220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides QSR Class II Orthopedic
2022-05-24 K212327 M-Vizion Monobloc LZO Class II Orthopedic
2022-05-04 K220705 MyKnee R Pin Positioners JWH Class II Orthopedic
2022-04-26 K220570 M.U.S.T. MINI Posterior Cervical Screws System Extension NKG Class II Orthopedic
2022-04-12 K220405 Amis K Long LZO Class II Orthopedic
2022-03-10 K213751 NextAR™ TKA Platform My Knee PPS SBF Class II Neurology
2022-02-03 K203335 MectaScrew Extension HWC Class II Orthopedic
2021-12-20 K202568 Mpact® 3D Metal Implants - DMLS Technology LPH Class II Orthopedic
2021-11-16 K213071 MOTOTM Partial Knee & MOTO PFJ Systems Extension HSX Class II Orthopedic
2021-11-05 K210859 NextAR™ Spine Platform SBF Class II Neurology
2021-10-29 K212831 MectaLIF Extension MAX Class II Orthopedic
2021-09-22 K210263 Mpres Neck Preserving Stem LZO Class II Orthopedic
2021-08-06 K211435 PAO Cortical Screw HWC Class II Orthopedic
2021-07-29 K211664 GMK Sphere Revision JWH Class II Orthopedic
2021-07-23 K211386 MySpine WebPlanner & MyBalance LLZ Class II Radiology
2021-05-13 K211004 GMK Spherika Femurs and Fixed Tibial Trays Plus JWH Class II Orthopedic
2021-05-12 K210153 NextAR RSA Platform SBF Class II Neurology
2021-04-28 K200391 MPACT Extension LPH Class II Orthopedic
2021-04-20 K210427 M.U.S.T. Midline Cortical (MC) Screw System NKB Class II Orthopedic
2021-04-12 K210456 Ligament Staple JDR Class II Orthopedic
2021-04-08 K210062 Mectaplug PE II JDK Class II General, Plastic Surgery
2021-04-06 K203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) PQC — —
2021-03-26 K210207 Humeral Eccentric Reverse Metaphysis PHX Class II Orthopedic
2021-03-26 K203259 FairFix Adjustable Button System MBI Class II Orthopedic
2021-03-02 K210010 GMK Revision & Hinge Extension - TiNbN Coating KRO — —
2021-03-02 K203755 Shoulder System - TiNbN Coating PHX Class II Orthopedic
2021-02-22 K203493 MectaLock Extension MAI Class II Orthopedic
2021-02-19 K200589 MyPAO Planning Report LLZ Class II Radiology
2021-01-26 K203482 M.U.S.T. Pedicle Screw Extension and Long Tab Implants NKB Class II Orthopedic
2021-01-19 K203485 SnugFit All-Suture Anchor MBI Class II Orthopedic
2021-01-13 K203671 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System OUR Class II Orthopedic
2021-01-11 K201471 M-Vizion Femoral Revision System Extension LZO Class II Orthopedic
2020-12-28 K202730 Quadra-P LZO Class II Orthopedic
2020-12-11 K202684 GMK Total Knee System - TiNbN Coating JWH Class II Orthopedic
2020-12-02 K203041 SMS Cementless Stem LZO Class II Orthopedic
2020-11-16 K203149 M.U.S.T. MINI Posterior Cervical Screws System NKG Class II Orthopedic
2020-11-06 K203076 Mecta-C Stand Alone Extension OVE Class II Orthopedic
2020-11-04 K200350 MyHip Planner & Verifier LLZ Class II Radiology
2020-10-27 K202152 NextAR TKA Platform SBF Class II Neurology
2020-10-01 K200067 MectaScope System HRX Class II Orthopedic
2020-09-18 K202022 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) JWH Class II Orthopedic
2020-09-18 K201673 SMS Cementless Stem LZO Class II Orthopedic
2020-04-29 K191816 M-Vizion Femoral Revision System Extension LZO Class II Orthopedic
2020-04-20 K200122 MOTO PFJ System KRR Class II Orthopedic
2020-03-25 K192967 Medacta Shoulder System PHX Class II Orthopedic
2020-03-13 K200075 3DMetal Diaphyseal Femoral Cones JWH Class II Orthopedic
2020-03-09 K200048 MectaLIF Anterior Simple MAX Class II Orthopedic
2020-03-04 K192906 Mecta-C Stand Alone OVE Class II Orthopedic
2020-02-10 K200130 M.U.S.T. MINI Posterior Cervical Screws System NKG Class II Orthopedic
2020-02-10 K193165 MectaFix CL Fixation Button with Continuous Loop MBI Class II Orthopedic
2020-02-06 K193461 MectaLock All-Suture Anchors MBI Class II Orthopedic
2020-01-29 K191677 MectaTap TI Suture Anchor MBI Class II Orthopedic
2020-01-27 K193365 M.U.S.T. Pedicle Screw System NKB Class II Orthopedic
2020-01-09 K193433 AMIStem-C LZO Class II Orthopedic
2020-01-06 K192827 Quadra-P LZO Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence