510(k) · Cleared
Recalled · Class II · 2025Ipc Powerease System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Oct 26, 2011 as substantially equivalent to K081475 (Medtronic Xomed, Inc., 2008) and 4 other predicates after a 146-day review. Its family tree reaches back 7 generations to 1986. 1 of the 477 devices in its family, counting itself, has a Class I recall. 418 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 26, 2011
- Review
- 146 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 7 generations to K862807 (1986). 58 ancestors in all, the oldest K842956 (1984). 418 later devices descend from it, 12 citing it directly. 1 of the 477 devices in this family, counting this one, has a Class I recall.
- 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 deviceK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011
- Descendant · cites it directly · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · cites it directly · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 242 of its ownK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 418 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 418 · See all- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · cites it directly404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly396descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · 2 generations on246descendants
- K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on242descendants
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) | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | — |
| +1 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +1 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +2 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| +2 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 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 |
|---|---|---|---|
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 1…wered driver that performs multiple functions and also has nerve stimulation capabilities. The IPO® POWEREASE TM System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is power… | 2008 |
| * | K063305 | Stimulating Bur GuardSummary page 2…MdrncXmd n. K845 1/720 -Drill System) -Stimulating Bur Guard Medtronic Xomed, Inc. K063305 11/29/2006 Stryker Consolidated Operating Room SrkrIsrmns1020 /620… | 2006 |
| * | K061113 | OrthomonSummary page 1…osts, and cutting rods during spinal surgery. The POWEREASE TM Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061 639 - 11/01/2006). An external POWEREASE M NIM Cable that connects the NIM-ECLIPSE® System to the driver… | 2006 |
| * | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Summary page 1…during spinal surgery. The POWEREASE TM Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061 639 - 11/01/2006). An external POWEREASE M NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to… | 2006 |
| * | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Summary page 2…Inc. K061639 11/01/2006 XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console Medtronic Xomed, Inc. K(081277 0/520 (IPC) _ _ _ _ _ _ _ _ _… | 2008 |
| * | — | Stryker Consolidated Operating Room Equipment (CORE) System Named without a submission number |
What descends from it? (418)
See all 41812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | 2013 | 404 |
| K123270 | Powerease System | 2013 | 398 |
| K140454 | Navigated CD Horizon Solera Screwdriver/Taps | 2014 | 396 |
| K143019 | CD HORIZON Spinal System, IPC POWEREASE System | 2015 | 88 |
| K153463 | CD HORIZON Spinal System, IPC POWEREASE System | 2015 | 87 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®… | 2017 | 86 |
| K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with… | 2016 | 84 |
| K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)… | 2016 | 79 |
| K201407 | CD Horizon™ Spinal System | 2020 | 54 |
| K210637 | CD Horizon™ Spinal System | 2021 | 34 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2025 | Class II | Z-2461-2025 | Process change control | Due to out of the box wobble of the driver. |
| Dec 3, 2014 | Class II | Z-0952-2015 | Process design | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 58 ancestors have a recall of any class.
- Of its descendants, K124004 (Medtronic Navigation, Inc., 2013) has gone furthest, with 404 descendants of its own.
- 10 other devices also cite its predicate K081475.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE TM System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111520: Ipc Powerease System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111520
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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