510(k) · Cleared
Recalled · 2004Stayfuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · HWC Screw, Fixation, Bone
Cleared on Apr 29, 1999 after a 50-day review. The FDA summary names its predicate without a number. 106 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 0
106 later devices descend from it, 8 citing it directly.
- This deviceK990804 StayfusePioneer Surgical Technology · 1999
- Descendant · cites it directly · 65 of its ownK022726 Stayfuse GT-IPPioneer Surgical Technology · 2002
- Descendant · 2 generations on · 63 of its ownK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- Descendant · 3 generations on · 56 of its ownK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
- Descendant · cites it directly · 27 of its ownK113006 I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
- Descendant · 3 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K022726Stayfuse GT-IPPioneer Surgical Technology · 2002 · cites it directly65descendants
- K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009 · 2 generations on63descendants
- K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · 3 generations on56descendants
- K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012 · cites it directly27descendants
- K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990804 | Stayfuse | Pioneer Surgical Technology | 1999 | — |
| +1 | K022726 | Stayfuse GT-IP | Pioneer Surgical Technology | 2002 | — |
| +2 | K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | 2009 | — |
| +3 | K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | Extremity Medical, LLC | 2010 | 2 |
| +1 | K113006 | I-Fuse Hammer Toe Systems | Orthopro, LLC | 2012 | — |
| +3 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 10 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | — | K-Wire Named without a submission number |
What descends from it? (106)
See all 1068 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022726 | Stayfuse GT-IP | 2002 | 65 |
| K113006 | I-Fuse Hammer Toe Systems | 2012 | 27 |
| K110445 | Flexfusion (TM) Fixation Implant | 2011 | 16 |
| K130859 | Hammertoe Correction System | 2013 | 4 |
| K173616 | DIP Arthrodesis System | 2018 | 0 |
| K162685 | 2-Piece Hammertoe Correction System | 2017 | 0 |
| K142528 | AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm | 2014 | 0 |
| K130019 | J-Screw Compression Screw | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2004 | Not classified | Z-0561-04 | Other | Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant. |
| May 28, 2003 | Not classified | Z-0948-03 | Other | Label may bear an incorrect part number [2227-02-02] and size [03.8MM]. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022726 (Pioneer Surgical Technology, 2002) has gone furthest, with 65 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
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/K990804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990804: Stayfuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990804
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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