510(k) · Cleared
Recalled · 2011Stryker Crossfire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 20, 2007 as substantially equivalent to K032303 (Stryker Instruments, 2004) and 2 other predicates after a 77-day review. Its family tree reaches back 7 generations to 2001. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 20, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K011083 (2001). 35 ancestors in all, the oldest K771218 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 6 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 5 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 4 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 3 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 2 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 1 generation backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
- This deviceK071859 Stryker Crossfire SystemStryker Endoscopy · 2007
- 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 ownK252666 Articulator Arthroscopic BurJoint Preservation Innovations, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK241008 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation, Subsidiary of Zimmer Biomet · 2024
Most influential descendants
Showing 4 of 4 · 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
- K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC · 2025 · cites it directly0descendants
- K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −6 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −5 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −3 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −2 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −1 | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | 3 |
| 0 (this device) | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | — |
| +1 | K162770 | Relign System | Relign Corporation | 2017 | — |
| +2 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver… | Relign Corporation | 2023 | — |
| +1 | K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025 | — |
| +2 | K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece… | Relign Corporation, Subsidiary of Zimmer Biomet | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K032303 | Stryker Consolidated Operating Room Equipment (Core) SystemSummary page 1…redicate Devices: The Stryker Crossfire System is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Stryker CORE (K032303), SEREAS Energy (K041810), and Total Performance Shaver (K973 195) Systems. Substantial Equivalence: When compared to the predic… | 2004 |
| * | K041810 | Serfas Energy SystemSummary page 1…yker Crossfire System is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Stryker CORE (K032303), SEREAS Energy (K041810), and Total Performance Shaver (K973 195) Systems. Substantial Equivalence: When compared to the predicated devices listed above… | 2004 |
| * | K973195 | Total Performance System ShaverSummary page 1…quivalent in terms of safety and effectiveness to currently marketed devices including the Stryker CORE (K032303), SEREAS Energy (K041810), and Total Performance Shaver (K973 195) Systems. Substantial Equivalence: When compared to the predicated devices listed above, the Stryker Crossfire System has the sa… | 1997 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2011 | Not classified | Z-0265-2012 | Component design/selection | An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011. |
| Jun 28, 2010 | Not classified | Z-2193-2010 | Software design | RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 7 of the 35 ancestors have a recall of any class.
- Of its descendants, K162770 (Relign Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K032303.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071859 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071859: Stryker Crossfire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071859
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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