510(k) · Cleared
ClearedXPS 3000 System
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 Jul 23, 2004 as substantially equivalent to K002224 (Medtronic Xomed, 2000) after a 45-day review. Its family tree reaches back 1 generation to 2000. 1 of the 461 devices in its family, counting itself, has a Class I recall. 459 later devices descend from it.
- Decided
- Jul 23, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002224 (2000). 459 later devices descend from it, 7 citing it directly. 1 of the 461 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- This deviceK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- Descendant · cites it directly · 448 of its ownK073255 XPS 3000 SystemMedtronic Xomed, Inc. · 2008
- Descendant · 2 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 420 of its ownK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 459 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 459 · See all- K073255XPS 3000 SystemMedtronic Xomed, Inc. · 2008 · cites it directly448descendants
- K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 2 generations on443descendants
- K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc. · 2008 · 2 generations on420descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 3 generations on418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 4 generations on404descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| 0 (this device) | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| +1 | K073255 | XPS 3000 System | Medtronic Xomed, Inc. | 2008 | — |
| +2 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| +2 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| +3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +4 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 15 | 0 |
| 2018 | 19 | 0 |
| 2019 | 26 | 0 |
| 2020 | 23 | 0 |
| 2021 | 43 | 1 |
| 2022 | 49 | 0 |
| 2023 | 63 | 0 |
| 2024 | 66 | 0 |
| 2025 | 65 | 0 |
| 2026 | 56 | 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? (1)
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 |
|---|---|---|---|
| * | K002224 | XPS 3000 SystemSummary page 3…The proposed XPS 3000 system is substantially equivalent in operating principle, technology, overall design, finction, and materials to the XPS system described in K002224. Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use.… | 2000 |
What descends from it? (459)
See all 4597 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073255 | XPS 3000 System | 2008 | 448 |
| K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | 2009 | 5 |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot… | 2015 | 2 |
| K233958 | hekaDrill | 2024 | 0 |
| K161376 | DragonFly Surgical Drill System | 2016 | 0 |
| K080052 | Stryker Essx with Navigation Mount | 2008 | 0 |
| K073633 | Stryker Essx Microdebrider System | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. Otology/neurotology indications include aural atresia, cholesteatoma, cochleostomy, development o fa suture tunnel for cochlear implant fixation, drainage ofpetrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression…
Read the full statement (287 words)
The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.
Otology/neurotology indications include aural atresia, cholesteatoma, cochleostomy, development o fa suture tunnel for cochlear implant fixation, drainage ofpetrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal ofear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.
Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures.
Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy
Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing ofthe bony vault and revision of the bonypyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.
The XPS 3000 system rising the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.
The XPS 3000 system with reciprocating adapter and suction cannula is intended forthe removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal ofsoft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041523: XPS 3000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041523
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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