Data / Medical devices / Switzerland / Medacta International SA

Medacta International SA: FDA-registered device maker in Rancate Ticino, Switzerland, 264 510(k) clearances

Name: Medacta International SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medacta International SA is registered with the FDA (registration 3008110533) in Rancate Ticino, Switzerland. It lists 109 device types. The FDA files 264 510(k) clearances under its listings, the newest dated September 17, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Medacta International SA

FDA registration number: 3008110533
Address: Via Alla Rossa 6, Rancate Ticino, Switzerland, 6862
Owner or operator: Medacta International SA (10024526)
Roles: Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed: February 11, 2008
Registered through: 2027
Brand names listed: 3DMetal Diaphyseal Femoral Cones, 3DMetal Tibial Cones, 9604UK Gaston sleeve, AMIS K Long, AMIS Table, AMIStem H;, AMIStem and Quadra - Line Extension, AMIStem-C and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Bone Cement	LOD	2	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Bone Cement, Antibiotic	MBB	2	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Cement Obturator	LZN	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Clamp	HXD	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Curette	HTF	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Dispenser, Cement	KIH	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Elevator	HTE	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Evacuator, Vapor, Cement Monomer	JDY	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Extractor	HWB	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Complaint file establishment, Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Gauge, Depth	HTJ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Impactor	HWA	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intraoperative Orthopedic Joint Assessment Aid	ONN	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Knife, Surgical	EMF	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Complaint file establishment, Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Augmented Reality	SBF	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Passer	HWQ	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Pedicle Screw Placement Guide	PQC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Posterior Cervical Screw Placement Guide	QSD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Probe	HXB	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Cement Restrictor	JDK	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	LZY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	MBF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Punch, Femoral Neck	HWP	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Rasp	HTR	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Reamer	HTO	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Rongeur	HTX	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Sacroiliac Screw Placement Guide	QSR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Shoulder Arthroplasty Implantation System	QHE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Spinal Channeling Instrument, Vertebroplasty	OCJ	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Starter, Bone Screw	HWD	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Stripper, Surgical	HRT	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Operating-Room, Mechanical	FWX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Tap, Bone	HWX	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 264.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 17, 2026	K260173	M-Vizion Femoral Revision System Extension	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 15, 2026	K262057	GMK Extension	JWH	Substantially Equivalent	Medacta International SA	accessdata.fda.gov
August 28, 2026	K253630	Mpact 3D Metal Foam	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
June 10, 2026	K261016	MSS - Humeral reverse liners extension	PHX	Substantially Equivalent	Medacta International, SA	accessdata.fda.gov
May 5, 2026	K254202	MectaLIF 3D Metal Anterior	OVD	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 28, 2026	K253940	M.U.S.T. Pedicle Screw System - Extension	NKB	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 26, 2026	K253328	GMK 3D Metal Tibial Tray Extension	MBH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 3, 2026	K250644	MSS - Monobloc stem	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 28, 2026	K251043	Mpact 3D Metal Implants Extension DMLS Technology	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 9, 2026	K252847	NextAR Hip Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 19, 2025	K242603	MyPAO SA guides	PBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 31, 2025	K250338	MSS - Humeral reverse liners extension	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 19, 2025	K250450	Coated hip implants	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 12, 2025	K252225	PowerKnot High Strength Sutures	GAT	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 4, 2025	K251737	NextAR(TM) Shoulder Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
August 13, 2025	K252201	HS Fiber	GAT	Substantially Equivalent	Riverpoint Medical	accessdata.fda.gov
July 31, 2025	K250477	NextAR(TM) Spine	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 31, 2025	K241461	Mpact Constrained Liner	KWZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 24, 2025	K251618	MOTO Partial Knee System Extension	HSX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 17, 2025	K251016	MectaLIF 3D Metal	MAX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 1, 2025	K251933	SnugFit ASA Extension	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
June 13, 2025	K251166	Mfinity Femoral System	MEH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 23, 2025	K243697	MySpine WebPlanner	LLZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 23, 2025	K242232	Mpact 3D Metal Augments II	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 6, 2025	K241767	Versacem Acetabular Shell and Double Mobility HC Liners	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 30, 2025	K241292	MyShoulder Planner (5.3SSWPL)	KWS	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
June 12, 2024	K241034	Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System	PML	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 3, 2024	K232733	Mbrace Cable	JDQ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 24, 2024	K233172	NextAR Spine Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 13, 2024	K234048	M.U.S.T. Pedicle Screw System - Extension	NKB	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
December 28, 2023	K230891	SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant	MBI	Substantially Equivalent	Healthium Medtech Limited	accessdata.fda.gov
December 7, 2023	K231515	MySpine Cervical Guides	QSD	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 9, 2023	K231911	Glenoid Reconstruction System Full Wedge Baseplate	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 29, 2023	K232280	NextAR TSA Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 18, 2023	K232123	MectaLIF Anterior Lag Extension	OVD	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 20, 2023	K230011	Mpact Extension	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
September 18, 2023	K232513	X-Twist Biocomposite Suture Anchor	MAI	Substantially Equivalent	Parcus Medical	accessdata.fda.gov
July 21, 2023	K231483	MySpine Unilateral Guides	PQC	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 21, 2023	K223769	NextAR Spine Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
June 9, 2023	K231037	MyKnee UNI-ST	JWH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 30, 2023	K220706	MyPAO Guides	PBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 12, 2023	K230394	EUROSCREW NG; EUROSCREW TCP NG	MAI	Substantially Equivalent	Teknimed	accessdata.fda.gov
April 17, 2023	K230544	SnugFit All-Suture Anchor extension	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 24, 2023	K223582	MectaLock TI Triple Loaded Suture Anchor	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 20, 2023	K223548	GMK Sphere & GMK SpheriKA Cementless	MBH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 20, 2023	K221725	Advanced MyHip Planner	LLZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 17, 2023	K223795	FairFix QT Adjustable Button	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 23, 2022	K213459	Glenoid Reconstruction System	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 24, 2022	K221545	MectaLIF Anterior Extension	OVD	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
August 23, 2022	K221850	GMK 3D Metal Tibial Tray	MBH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
August 16, 2022	K222169	FairFix Adjustable Button System	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 26, 2022	K221502	Parcus Synd-EZ SS	MBI	Substantially Equivalent	Parcus Medical, LLC	accessdata.fda.gov
July 22, 2022	K211891	DM Converter - TiN coated	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
June 8, 2022	K221389	FairFix AM Adjustable Button FairFix PSP Adjustable Button	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 24, 2022	K220888	MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides	QSR	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 24, 2022	K212327	M-Vizion Monobloc	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 19, 2022	K221135	X-Twist PEEK Suture Anchor	MBI	Substantially Equivalent	Parcus Medical, LLC	accessdata.fda.gov
May 4, 2022	K220705	MyKnee R Pin Positioners	JWH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 26, 2022	K220570	M.U.S.T. MINI Posterior Cervical Screws System Extension	NKG	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 12, 2022	K220405	Amis K Long	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 10, 2022	K213751	NextAR TKA Platform My Knee PPS	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 3, 2022	K203335	MectaScrew Extension	HWC	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
December 20, 2021	K202568	Mpact® 3D Metal Implants - DMLS Technology	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 16, 2021	K213071	MOTOTM Partial Knee & MOTO PFJ Systems Extension	HSX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 5, 2021	K210859	NextAR Spine Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 29, 2021	K212831	MectaLIF Extension	MAX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 6, 2021	K212739	ActiFlip	MBI	Substantially Equivalent	Parcus Medical, LLC	accessdata.fda.gov
September 22, 2021	K210263	Mpres Neck Preserving Stem	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
August 6, 2021	K211435	PAO Cortical Screw	HWC	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 29, 2021	K211664	GMK Sphere Revision	JWH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
July 23, 2021	K211386	MySpine WebPlanner & MyBalance	LLZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 13, 2021	K211004	GMK Spherika Femurs and Fixed Tibial Trays Plus	JWH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
May 12, 2021	K210153	NextAR RSA Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 28, 2021	K200391	MPACT Extension	LPH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 20, 2021	K210427	M.U.S.T. Midline Cortical (MC) Screw System	NKB	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 12, 2021	K210456	Ligament Staple	JDR	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 8, 2021	K210062	Mectaplug PE II	JDK	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
April 6, 2021	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	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 26, 2021	K210207	Humeral Eccentric Reverse Metaphysis	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 26, 2021	K203259	FairFix Adjustable Button System	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 2, 2021	K210010	GMK Revision & Hinge Extension - TiNbN Coating	KRO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
March 2, 2021	K203755	Shoulder System - TiNbN Coating	PHX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 22, 2021	K203493	MectaLock Extension	MAI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 22, 2021	K202662	Parcus Titanium Interference Screws	MBI	Substantially Equivalent	Parcus Medical, LLC	accessdata.fda.gov
February 19, 2021	K200589	MyPAO Planning Report	LLZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
February 12, 2021	K200551	MectaLIF Transforaminal TiPEEK	MAX	Substantially Equivalent	Medacta Inernational SA	accessdata.fda.gov
January 26, 2021	K203482	M.U.S.T. Pedicle Screw Extension and Long Tab Implants	NKB	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 19, 2021	K203485	SnugFit All-Suture Anchor	MBI	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 13, 2021	K203671	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	OUR	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
January 11, 2021	K201471	M-Vizion Femoral Revision System Extension	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
December 28, 2020	K202730	Quadra-P	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
December 11, 2020	K202684	GMK Total Knee System - TiNbN Coating	JWH	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
December 2, 2020	K203041	SMS Cementless Stem	LZO	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 16, 2020	K203149	M.U.S.T. MINI Posterior Cervical Screws System	NKG	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 6, 2020	K203076	Mecta-C Stand Alone Extension	OVE	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
November 4, 2020	K200350	MyHip Planner & Verifier	LLZ	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 28, 2020	K202259	Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip	MBI	Substantially Equivalent	Parcus Medical, LLC	accessdata.fda.gov
October 27, 2020	K202152	NextAR TKA Platform	SBF	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov
October 5, 2020	K200792	MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides	PQC	Substantially Equivalent	Medacta Inernational SA	accessdata.fda.gov
October 1, 2020	K200067	MectaScope System	HRX	Substantially Equivalent	Medacta International S.A.	accessdata.fda.gov

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Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.