510(k) · Cleared
ClearedXPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Aug 14, 2015 as substantially equivalent to K041413 (Medtronic Xomed, Inc., 2004) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Aug 14, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862807 (1986). 27 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 3 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 2 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 1 generation backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- This deviceK150728 XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −6 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −3 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −2 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −1 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| 0 (this device) | K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ERL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041413 | XPS 3000 SystemSummary page 4…se and throat electric or pneumatic surgical drill (21 CFR 874.4250, Product Code: ERL, Class II) Premarket Notification: K041413 Trade Name: IPC® Integrated Power Console Common/Usual Name: Drill, Surgical, ENT (elec… | 2004 |
| * | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Summary page 4…se and throat electric or pneumatic surgical drill (21 CFR 874.4250, Product Code: ERL, Class II) Premarket Notification: K081277 G. Device Description The XPS Nexus™ System is a powered microdebrider and drill system that removes soft tissue, hard ti… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 27 ancestors have a recall of any class.
- 4 other devices also cite its predicate K041413.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck/ENT, oral/maxillofacial and plastic/reconstructive/aesthetic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150728: XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150728
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026