510(k) · Cleared
ClearedCurvaFix Intramedullary Rodscrew System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curvafix, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 1, 2019 as substantially equivalent to K043185 (Synthes (Usa), 2005) after a 417-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Mar 1, 2019
- Review
- 417 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043185 (2005). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK043185 Synthes 3.5MM Cortex ScrewsSynthes (Usa) · 2005
- This deviceK180050 CurvaFix Intramedullary Rodscrew SystemCurvafix, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK222505 CurvaFix IM SystemCurvafix, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK200295 IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043185 | Synthes 3.5MM Cortex Screws | Synthes (Usa) | 2005 | — |
| 0 (this device) | K180050 | CurvaFix Intramedullary Rodscrew System | Curvafix, Inc. | 2019 | — |
| +1 | K222505 | CurvaFix IM System | Curvafix, Inc. | 2022 | — |
| +1 | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025 | — |
| +1 | K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 4…ts are manufactured from stainless steel (316 LVM per ASTM F138) . Primary Predicate: Primary: 3.5 mm Pelvic Cortex Screws (Synthes Inc. – K043185) Performance Data: Mechanical testing of worst case CurvaFix Intramedullary Rodscrew was performe… | 2005 |
What descends from it? (3)
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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.
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/K180050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180050: CurvaFix Intramedullary Rodscrew System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180050
Report an extraction error
Are you the manufacturer?
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