Medical device manufacturer
Medacta International S.A.
Medacta International S.A. holds 165 FDA 510(k) clearances across 38 product codes. Median elapsed review time is 93 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 165
- Product codes
- 38
- Median review
- 93 days
- Recall records
- 0
How does FDA spell Medacta International S.A.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Medacta International S.A. file in?
38 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 27 | 101 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 17 | 87 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 15 | 60 days | |
| PHX | Shoulder Prosthesis, Reverse Configuration | 12 | 154 days | |
| SBF | Orthopedic Augmented Reality | 10 | 111 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 8 | 54 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 270 days | |
| NKG | Posterior Cervical Screw System | 6 | 29 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 5 | 90 days | |
| LLZ | System, Image Processing, Radiological | 5 | 220 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 60 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 | 94 days | |
| HWC | Screw, Fixation, Bone | 3 | 88 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 97 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 3 | 57 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 3 | 57 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 168 days | |
| OUR | Sacroiliac Joint Fixation | 3 | 28 days | |
| PQC | Pedicle Screw Placement Guide | 3 | 111 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 141 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 24 days | |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | 446 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 58 days | |
| HAW | Neurological Stereotaxic Instrument | 1 | 55 days | |
| HRX | Arthroscope | 1 | 262 days |
Showing the 25 they file in most, of 38.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Medacta International S.A. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Medacta International S.A. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254202 | MectaLIF 3D Metal Anterior | OVD | 127 | |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | NKB | 140 | |
| K253328 | GMK 3D Metal Tibial Tray Extension | MBH | 149 | |
| K250644 | MSS - Monobloc stem | PHX | 336 | |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | LPH | 300 | |
| K252847 | NextAR Hip Platform | SBF | 123 | |
| K242603 | MyPAO SA guides | PBF | 446 | |
| K250338 | MSS - Humeral reverse liners extension | PHX | 267 | |
| K250450 | Coated hip implants | LZO | 213 | |
| K252225 | PowerKnot High Strength Sutures | GAT | 58 |
Source: openFDA device/510k · retrieved
Watch what Medacta International S.A. files next
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