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
| Code | Device | Records |
|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 6 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 |
| FWX | Table, Operating-Room, Mechanical | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2026 | Medacta 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 |
PHX | K250644 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device Completed |
OVD | K221545 |
| Dec 3, 2022 | Medacta 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 |
OLO | K210153 |
| Apr 13, 2022 | Medacta Usa Inc GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 Terminated |
LXH | None listed |
| Nov 4, 2019 | Medacta 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 |
KWS | K170910 |
| Dec 20, 2017 | Medacta 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 |
JWH | K090988 |
| Nov 15, 2017 | Medacta 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 |
LZO | K170845 |
| Jun 12, 2017 | Medacta Usa Inc Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO Terminated |
KRO | K130299 |
| Jan 13, 2017 | Medacta 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 |
KWP | K121115 |
| Nov 14, 2015 | Medacta Usa GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery Terminated |
KRO | K130299 |
| Nov 18, 2014 | Medacta Usa The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants. Terminated |
MAX | K110927 |
| Nov 12, 2014 | Medacta 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 |
HSB | None listed |
| Feb 23, 2013 | Medacta 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 |
MEH | K083116 |
| Feb 7, 2013 | Medacta 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 |
MEH | K072857 K082792 +3 |
| Nov 8, 2012 | Medacta 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 |
JDI | None listed |
| Jun 30, 2011 | Medacta 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 |
MEH | K083116 |
| Sep 11, 2009 | Medacta 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 |
JWH | K081023 |
| Sep 16, 2008 | Medacta 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 |
FWX | None listed |