ClearanceBrief
Company

Medacta Usa Inc

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
23recalls (1 in 12 months)
19recalls that name a 510(k)

Product codes

CodeDeviceRecords
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar6
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate3
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2
FWXTable, Operating-Room, Mechanical1
HSBRod, Fixation, Intramedullary And Accessories1
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1
KWPAppliance, Fixation, Spinal Interlaminal1
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1
LXHOrthopedic Manual Surgical Instrument1
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1
MAXIntervertebral Fusion Device With Bone Graft, Lumbar1
OLOOrthopedic Stereotaxic Instrument1
PHXShoulder Prosthesis, Reverse Configuration1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 29, 2026Medacta Usa Inc
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 1
Open, Classified
PHXK250644
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Completed
OVDK221545
Apr 19, 2023Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Completed
OVDK221545
Dec 3, 2022Medacta Usa Inc
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Terminated
OLOK210153
Apr 13, 2022Medacta Usa Inc
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Terminated
LXHNone listed
Nov 4, 2019Medacta Usa Inc
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral frac
Terminated
KWSK170910
Dec 20, 2017Medacta Usa Inc
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF
Terminated
JWHK090988
Nov 15, 2017Medacta Usa Inc
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Terminated
LZOK170845
Jun 12, 2017Medacta Usa Inc
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Terminated
KROK130299
Jan 13, 2017Medacta Usa Inc
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable cons
Terminated
KWPK121115
Nov 14, 2015Medacta Usa
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Terminated
KROK130299
Nov 18, 2014Medacta Usa
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Terminated
MAXK110927
Nov 12, 2014Medacta Usa
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Terminated
HSBNone listed
Feb 23, 2013Medacta Usa Inc
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.2
Terminated
MEHK083116
Feb 7, 2013Medacta Usa Inc
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create
Terminated
MEHK072857
K082792 +3
Nov 8, 2012Medacta Usa Inc
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the fem
Terminated
JDINone listed
Jun 30, 2011Medacta Usa Inc
Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cement
Terminated
MEHK083116
Sep 11, 2009Medacta Usa Inc
Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The f
Terminated
JWHK081023
Sep 16, 2008Medacta Usa Inc
Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery
Terminated
FWXNone listed
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