510(k) · Cleared
Recalled · Class II · 2021XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)
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 Sep 5, 2008 as substantially equivalent to K073255 (Medtronic Xomed, Inc., 2008) and 5 other predicates after a 123-day review. Its family tree reaches back 6 generations to 1986. 1 of the 447 devices in its family, counting itself, has a Class I recall. 420 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 2008
- Review
- 123 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K862807 (1986). 26 ancestors in all, the oldest K852143 (1985). 420 later devices descend from it, 3 citing it directly. 1 of the 447 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 2 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 1 generation backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- This deviceK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008
- Descendant · cites it directly · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 420 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 420 · See all- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · cites it directly418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 2 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on396descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · 3 generations on246descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −5 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −1 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| 0 (this device) | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | — |
| +1 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +2 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +2 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +3 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 26 | 0 |
| 2020 | 22 | 0 |
| 2021 | 41 | 1 |
| 2022 | 45 | 0 |
| 2023 | 62 | 0 |
| 2024 | 59 | 0 |
| 2025 | 61 | 0 |
| 2026 | 54 | 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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K073255 | XPS 3000 SystemSummary page 1…(21 CFR 874.4420, Product Code EWQ, Class I) Marketed device claiming equivalence to The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K0025… | 2008 |
| * | K935567 | Sodem Power SystemSummary page 1…WQ, Class I) Marketed device claiming equivalence to The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523). Device Description The electric dril… | 1994 |
| * | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Summary page 1…I) Marketed device claiming equivalence to The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523). Device Description The electric drill system… | 2001 |
| * | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat)Summary page 1…eted device claiming equivalence to The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523). Device Description The electric drill system consists… | 2001 |
| * | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery)Summary page 1…ce claiming equivalence to The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523). Device Description The electric drill system consists of a powe… | 2001 |
| * | K002523 | Advantage Drive SystemSummary page 1…ent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523). Device Description The electric drill system consists of a power console, footswitches, connection cables, irrigation / coolin… | 2000 |
What descends from it? (420)
See all 4203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2021 | Class II | Z-0961-2022 | 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… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K111520 (Medtronic Xomed, Inc., 2011) has gone furthest, with 418 descendants of its own.
- 2 other devices also cite its predicate K073255.
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. 2008, 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 Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic Surgical Procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081277 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081277
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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