510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medacta International SA

Castel San Pietro Ticino, CH

MEDACTA INTERNATIONAL SA appears in FDA device records in Castel San Pietro Ticino, CH. FDA records list 205 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
205
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

Showing 50 of 205

FDA records hold 205 510(k) clearances for Medacta International SA between 2008 and 2026. The busiest year on record is 2021, with 25. The most recent is 2026, with 7.

Clearances by year, as a table
510(k) clearance decisions for Medacta International SA, by decision year
YearClearances
20085
20095
20107
20118
201210
20139
20148
20153
20166
201720
201810
201913
202023
202125
202213
202314
20244
202515
20267
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261016MSS - Humeral reverse liners extensionPHXSubstantially Equivalent
K254202MectaLIF 3D Metal AnteriorOVDSubstantially Equivalent
K253940M.U.S.T. Pedicle Screw System - ExtensionNKBSubstantially Equivalent
K253328GMK 3D Metal Tibial Tray ExtensionMBHSubstantially Equivalent
K250644MSS - Monobloc stemPHXSubstantially Equivalent
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyLPHSubstantially Equivalent
K252847NextAR Hip PlatformSBFSubstantially Equivalent
K242603MyPAO SA guidesPBFSubstantially Equivalent
K250338MSS - Humeral reverse liners extensionPHXSubstantially Equivalent
K250450Coated hip implantsLZOSubstantially Equivalent
K252225PowerKnot High Strength SuturesGATSubstantially Equivalent
K251737NextAR(TM) Shoulder PlatformSBFSubstantially Equivalent
K250477NextAR(TM) SpineSBFSubstantially Equivalent
K241461Mpact Constrained LinerKWZSubstantially Equivalent
K251618MOTO Partial Knee System ExtensionHSXSubstantially Equivalent
K251016MectaLIF 3D MetalMAXSubstantially Equivalent
K251933SnugFit ASA ExtensionMBISubstantially Equivalent
K251166Mfinity Femoral SystemMEHSubstantially Equivalent
K243697MySpine WebPlannerLLZSubstantially Equivalent
K242232Mpact 3D Metal Augments IILPHSubstantially Equivalent
K241767Versacem Acetabular Shell and Double Mobility HC LinersLZOSubstantially Equivalent
K241292MyShoulder Planner (5.3SSWPL)KWSSubstantially Equivalent
K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPMLSubstantially Equivalent
K232733Mbrace CableJDQSubstantially Equivalent
K233172NextAR™ Spine PlatformSBFSubstantially Equivalent
K234048M.U.S.T. Pedicle Screw System - ExtensionNKBSubstantially Equivalent
K231515MySpine Cervical GuidesQSDSubstantially Equivalent
K231911Glenoid Reconstruction System – Full Wedge BaseplatePHXSubstantially Equivalent
K232280NextAR™ TSA PlatformSBFSubstantially Equivalent
K232123MectaLIF Anterior Lag ExtensionOVDSubstantially Equivalent
K230011Mpact ExtensionLPHSubstantially Equivalent
K231483MySpine Unilateral GuidesPQCSubstantially Equivalent
K223769NextAR™ Spine PlatformSBFSubstantially Equivalent
K231037MyKnee UNI-STJWHSubstantially Equivalent
K220706MyPAO GuidesPBFSubstantially Equivalent
K230544SnugFit All-Suture Anchor extensionMBISubstantially Equivalent
K223582MectaLock TI Triple Loaded Suture AnchorMBISubstantially Equivalent
K223548GMK Sphere & GMK SpheriKA CementlessMBHSubstantially Equivalent
K221725Advanced MyHip PlannerLLZSubstantially Equivalent
K223795FairFix QT Adjustable ButtonMBISubstantially Equivalent
K213459Glenoid Reconstruction SystemPHXSubstantially Equivalent
K221545MectaLIF Anterior ExtensionOVDSubstantially Equivalent
K221850GMK 3D Metal Tibial TrayMBHSubstantially Equivalent
K222169FairFix Adjustable Button SystemMBISubstantially Equivalent
K211891DM Converter - TiN coatedLZOSubstantially Equivalent
K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMBISubstantially Equivalent
K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesQSRSubstantially Equivalent
K212327M-Vizion MonoblocLZOSubstantially Equivalent
K220705MyKnee R Pin PositionersJWHSubstantially Equivalent
K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionNKGSubstantially Equivalent

Registered establishments

FDA registered establishments for Medacta International SA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30051809203005180920MEDACTA INTERNATIONAL SAStrada Regina, Castel San Pietro Ticino 6874 CH2026and 99 more, listed in full below
30081105333008110533MEDACTA INTERNATIONAL SAVia Alla Rossa 6, Rancate Ticino 6862 CH2026and 99 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain