510(k) · Cleared
ClearedStryker Crossflow Arthroscopy Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HRX Arthroscope
Cleared on Jan 9, 2013 as substantially equivalent to K030402 (W.O.M. World of Medicine AG, 2003) after a 62-day review. Its family tree reaches back 5 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 9, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950035 (1996). 10 ancestors in all, the oldest K912453 (1991). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 4 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 3 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 2 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 1 generation backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- This deviceK123441 Stryker Crossflow Arthroscopy PumpStryker Endoscopy · 2013
- Descendant · cites it directly · 2 of its ownK162770 Relign SystemRelign Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
- Descendant · cites it directly · 0 of its ownK250795 Purevue™ FMSW.O.M. World of Medicine GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK241008 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation, Subsidiary of Zimmer Biomet · 2024
- Descendant · cites it directly · 0 of its ownK191259 Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
Most influential descendants
Showing 5 of 5 · See all- K162770Relign SystemRelign Corporation · 2017 · cites it directly2descendants
- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation · 2023 · 2 generations on1descendant
- K250795Purevue™ FMSW.O.M. World of Medicine GmbH · 2025 · cites it directly0descendants
- K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet · 2024 · 2 generations on0descendants
- K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −4 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −3 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K123441 | Stryker Crossflow Arthroscopy Pump | Stryker Endoscopy | 2013 | — |
| +1 | K162770 | Relign System | Relign Corporation | 2017 | — |
| +2 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver… | Relign Corporation | 2023 | — |
| +1 | K250795 | Purevue™ FMS | W.O.M. World of Medicine GmbH | 2025 | — |
| +2 | K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece… | Relign Corporation, Subsidiary of Zimmer Biomet | 2024 | — |
| +1 | K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K030402 | Arthroscopy Pump, Model A107Summary page 1…21 CFR 888.1100 - Arthroscope and accessories Device Classification: Class H Premarket Notification: K030402 Device Description The Stryker CrossFlow Integrated Arthroscopy Pump is a microprocess… | 2003 |
What descends from it? (5)
3 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 17 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K162770 (Relign Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K030402.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123441: Stryker Crossflow Arthroscopy Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123441
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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