510(k) · Cleared
ClearedE9000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on Jul 15, 1999 as substantially equivalent to K981636 (Linvatec Corp., 1998) and 3 other predicates after a 146-day review. Its family tree reaches back 4 generations to 1986. 1 of the 493 devices in its family, counting itself, has a Class I recall. 477 later devices descend from it.
- Decided
- Jul 15, 1999
- Review
- 146 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K862807 (1986). 15 ancestors in all, the oldest K852143 (1985). 477 later devices descend from it, 11 citing it directly. 1 of the 493 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 3 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 2 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 1 generation backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- This deviceK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · cites it directly · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · cites it directly · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · cites it directly · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 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
Showing 5 of 477 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 477 · See all- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · cites it directly447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · cites it directly447descendants
- K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · cites it directly446descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −3 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −2 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −1 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| 0 (this device) | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +1 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +1 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +1 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 27 | 0 |
| 2020 | 24 | 0 |
| 2021 | 45 | 1 |
| 2022 | 47 | 0 |
| 2023 | 64 | 0 |
| 2024 | 64 | 0 |
| 2025 | 67 | 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K981636 | Integrated Drive/Pump SystemSummary page 4…pinal, surgical procedures. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. 510(K) K990254 K981636 & K981637 K971059 K862474 NUMBER . ACCESSORIES | Blades, Burs, Routers, Attachments, | Blades, Burs, Routers, Blades, Burs, Attac… | 1998 |
| * | K981637 | Integrated Drive/Pump System for OtolaryngologySummary page 4…gical procedures. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. 510(K) K990254 K981636 & K981637 K971059 K862474 NUMBER . ACCESSORIES | Blades, Burs, Routers, Attachments, | Blades, Burs, Routers, Blades, Burs, Attachments, Fo… | 1998 |
| * | K971059 | Universal Drive SystemSummary page 4…ocedures. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. 510(K) K990254 K981636 & K981637 K971059 K862474 NUMBER . ACCESSORIES | Blades, Burs, Routers, Attachments, | Blades, Burs, Routers, Blades, Burs, Attachments, Foot | Bla… | 1997 |
| * | K862474 | Hall Sternum SawSummary page 4…. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. 510(K) K990254 K981636 & K981637 K971059 K862474 NUMBER . ACCESSORIES | Blades, Burs, Routers, Attachments, | Blades, Burs, Routers, Blades, Burs, Attachments, Foot | Blades, Bat… | 1986 |
What descends from it? (477)
See all 47711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | 2001 | 447 |
| K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | 2001 | 447 |
| K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | 2001 | 446 |
| K083284 | Piezosurgery Medical | 2009 | 9 |
| K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) | 2009 | 9 |
| K061134 | Eberle Shaver System C2 and Shaver Blades | 2006 | 2 |
| K092977 | Eberle Shaver System Accessories | 2010 | 1 |
| K060172 | Rema Shaver Blades | 2006 | 0 |
| K052695 | Suretek Medical Reprocessed Arthroscopic Blades and Burs | 2006 | 0 |
| K012630 | Reprocessed Linvatec Arthroscopic Burs | 2001 | 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K012453 (Sodemsystems, 2001) has gone furthest, with 447 descendants of its own.
- 3 other devices also cite its predicate K981636.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The E9000 System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Arthroscopic, Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990524 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990524: E9000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990524
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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