510(k) · Cleared
Recalled · 2004Integrated Drive/Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on Aug 20, 1998 after a 104-day review. The FDA summary names its predicate without a number. 1 of the 480 devices in its family, counting itself, has a Class I recall. 479 later devices descend from it. It has been recalled once.
- Decided
- Aug 20, 1998
- Review
- 104 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 0
479 later devices descend from it, 4 citing it directly. 1 of the 480 devices in this family, counting this one, has a Class I recall.
- This deviceK981636 Integrated Drive/Pump SystemLinvatec Corp. · 1998
- Descendant · cites it directly · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · 2 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · 2 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · 2 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- Descendant · 3 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
Showing 5 of 479 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 479 · See all- K990524E9000 SystemLinvatec Corp. · 1999 · cites it directly477descendants
- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 2 generations on447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 2 generations on447descendants
- K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 2 generations on446descendants
- K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 3 generations on443descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981636 | Integrated Drive/Pump System | Linvatec Corp. | 1998 | — |
| +1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +2 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +2 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +2 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| +3 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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 | 17 | 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 |
|---|---|---|---|
| * | — | Universal Drive System Named without a submission number | |
| * | — | Hall® Irrigation System Named without a submission number | |
| * | — | TPS Total Performance System Named without a submission number | |
| * | — | Hummer 2® Named without a submission number |
What descends from it? (479)
See all 4794 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 |
|---|---|---|---|---|
| Aug 26, 2004 | Not classified | Z-0041-05 | Packaging process control | The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable. |
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990524 (Linvatec Corp., 1999) has gone furthest, with 477 descendants of its own.
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 Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal 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/K981636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981636: Integrated Drive/Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981636
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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