Trialtis
Trialtis is the listed name associated with Medos International’s TriALTIS Navigation Enabled Instruments. The FDA filing describes reusable instruments for preparing and placing DePuy…
Trialtis is the listed name associated with Medos International’s TriALTIS Navigation Enabled Instruments. The FDA filing describes reusable instruments for preparing and placing DePuy Synthes screws during spinal surgery.
The instruments assist the surgeon in locating anatomical structures in open or percutaneous procedures. The filing specifies use with the Medtronic StealthStation System and the particular DePuy Synthes implant systems named in its indications.
Listed Item
TRIALTIS Spine System Probe, Thoracic Straight, Navigation 0-5cm ± 4%
Device Function and Details
The filing names drills, taps and screwdrivers among the instruments. It states that they are made from stainless steel or titanium alloy, with one device coated in aluminum titanium nitride.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K231527 |
| Record published | 2024-02-01 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5161-00-2070 | In distribution | |
| 5161-00-5067 | In distribution | |
| 5161-00-5061 | In distribution | |
| 5161-00-2040 | In distribution | |
| 5161-00-1040 | In distribution | |
| 5161-00-2120 | In distribution | |
| 5161-00-1055 | In distribution | |
| 5161-00-2050 | In distribution | |
| 5161-00-5089 | In distribution | |
| 5161-00-2080 | In distribution | |
| 5161-00-2035 | In distribution | |
| 5161-00-1100 | In distribution | |
| 5161-00-5080 | In distribution | |
| 5161-00-2065 | In distribution | |
| 5161-00-5068 | In distribution | |
| 5161-00-1105 | In distribution | |
| 5161-00-5116 | In distribution | |
| 5161-00-5062 | In distribution | |
| 5161-00-1075 | In distribution | |
| 5161-00-2110 | In distribution | |
| 5161-00-5083 | In distribution | |
| 5161-00-1110 | In distribution | |
| 5161-00-2105 | In distribution | |
| 5161-00-1060 | In distribution | |
| 5161-00-1065 | In distribution | |
| 5161-00-2075 | In distribution | |
| 5161-00-5081 | In distribution | |
| 5161-00-2055 | In distribution | |
| 5161-00-5069 | In distribution | |
| 5161-00-2095 | In distribution | |
| 5161-00-1090 | In distribution | |
| 5161-00-2085 | In distribution | |
| 5161-00-1080 | In distribution | |
| 5161-00-1095 | In distribution | |
| 5161-00-1070 | In distribution | |
| 5161-00-5066 | In distribution | |
| 5161-00-1035 | In distribution | |
| 5161-00-2090 | In distribution | |
| 5161-00-1045 | In distribution | |
| 5161-00-2100 | In distribution | |
| 5161-00-1050 | In distribution | |
| 5161-00-2060 | In distribution | |
| 5161-00-1120 | In distribution | |
| 5161-00-5064 | In distribution | |
| 5161-00-2045 | In distribution | |
| 5161-00-1085 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231527 | 2023-09-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.