XPS Nexus
The XPS Nexus console powers compatible microdebrider and drill handpieces for cutting, removing or drilling soft tissue, hard tissue and bone. Its integrated pump provides irrigation to…
The XPS Nexus console powers compatible microdebrider and drill handpieces for cutting, removing or drilling soft tissue, hard tissue and bone. Its integrated pump provides irrigation to blades and burs. A foot control unit operates within the powered surgical system.
Compatible handpiece options include StraightShot M2 and M4 microdebriders and the Indigo Otology Drill. They drive burs, blades, drills, rasps or cannulas as appropriate to the selected handpiece. The console is the power and irrigation component rather than the cutting instrument itself.
Listed Item
Console 1894510 XPS Nexus W/Pump Rohs
Surgical Applications
System indications cover head and neck or ENT, oral and maxillofacial, and plastic, reconstructive or aesthetic surgical procedures. Optional accessories include an IV pole for irrigation solution bags and a carrying case. The tissue-removal function depends on the connected handpiece and surgical attachment.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K150728 |
| Record published | 2025-06-23 |
| Record revised | 2023-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature 10 to 33 °C; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1894510 | In distribution | |
| 1894520 | In distribution | |
| 1894510 | In distribution | |
| 1894520 | In distribution | |
| 1894510 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ENT MR8 | Medtronic Powered Surgical Solutions | 234 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Anspach Effort, The | 214 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Karl Storz GmbH & Co. KG | 208 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Synthes Gmbh | 126 |
| Midas Rex | Medtronic Powered Surgical Solutions | 97 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Stryker GmbH | 87 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| Zethon | Zethon Ltd | 39 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150728 | 2015-08-14 |
| K081277 | 2008-09-05 |
| K073255 | 2008-03-24 |
| K041523 | 2004-07-23 |
| K041413 | 2004-07-12 |
| K011321 | 2001-06-26 |
| K002224 | 2000-12-04 |
| K963246 | 1996-09-23 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-12-15 | Class II | Under Investigation by firm | As a result of Medtronic’s integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rota | 1447 units | 2023-06-09 |
| 2020-06-12 | Class II | Software design | During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole. | 673 units | 2023-04-20 |
| 2009-07-17 | Not classified | Software design | An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console. | 493 | 2010-01-20 |
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.