510(k) · Cleared
ClearedArthro-Surgimat-2000 Ecu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HRX Arthroscope
Cleared on Feb 26, 1999 as substantially equivalent to K983910 (W.O.M. World of Medicine GmbH, 1998) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1996. 30 later devices descend from it.
- Decided
- Feb 26, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K950035 (1996). 7 ancestors in all, the oldest K912453 (1991). 30 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 2 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 1 generation backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- This deviceK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- Descendant · cites it directly · 29 of its ownK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- Descendant · 2 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- Descendant · 3 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 4 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 2 generations on · 5 of its ownK123441 Stryker Crossflow Arthroscopy PumpStryker Endoscopy · 2013
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003 · cites it directly29descendants
- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 2 generations on15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 3 generations on14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 4 generations on6descendants
- K123441Stryker Crossflow Arthroscopy PumpStryker Endoscopy · 2013 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −2 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −1 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| 0 (this device) | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| +1 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| +2 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| +3 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +4 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +2 | K123441 | Stryker Crossflow Arthroscopy Pump | Stryker Endoscopy | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in HRX? 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? (3)
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 |
|---|---|---|---|
| * | K983910 | Arthro-Surgimat-1500Summary page 1…hroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M, GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Ape… | 1998 |
| * | K981859 | Surgiflator-20 EcuSummary page 1…substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M, GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Irrigation System (K933873). With the exception of the following modifications, the ARTHRO-SURG… | 1998 |
| * | K933873 | Concept Universal Pump SystemSummary page 1…(K983910) manufactured by W.O.M, GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Irrigation System (K933873). With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and acce… | 1994 |
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K030402 (W.O.M. World of Medicine AG, 2003) has gone furthest, with 29 descendants of its own.
- 2 other devices also cite its predicate K983910.
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 Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).
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/K990443 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990443: Arthro-Surgimat-2000 Ecu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990443
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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