510(k) · Cleared
ClearedSign Fin Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Implant Generation Network (Sign) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 3, 2005 after a 77-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK043200 Sign Fin NailSurgical Implant Generation Network (Sign) · 2005
- Descendant · cites it directly · 2 of its ownK083582 Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009
- Descendant · 2 generations on · 0 of its ownK153759 SIGN Compression Screw SystemSign Fracture Care International · 2016
- Descendant · 2 generations on · 0 of its ownK152757 SIGN Hip Construct (SHC)Sign Fracture Care International · 2015
- Descendant · cites it directly · 0 of its ownK122823 Sign Pediatric Fin NailSign Fracture Care International · 2013
Most influential descendants
Showing 4 of 4 · See all- K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009 · cites it directly2descendants
- K153759SIGN Compression Screw SystemSign Fracture Care International · 2016 · 2 generations on0descendants
- K152757SIGN Hip Construct (SHC)Sign Fracture Care International · 2015 · 2 generations on0descendants
- K122823Sign Pediatric Fin NailSign Fracture Care International · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043200 | Sign Fin Nail | Surgical Implant Generation Network (Sign) | 2005 | — |
| +1 | K083582 | Sign Hip Construct (SHC), Model: 701 | Surgical Implant Generation Network (Sign) | 2009 | — |
| +2 | K153759 | SIGN Compression Screw System | Sign Fracture Care International | 2016 | — |
| +2 | K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015 | — |
| +1 | K122823 | Sign Pediatric Fin Nail | Sign Fracture Care International | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | SIGN HA Nail System Named without a submission number | |
| * | — | Howmedica Alta HA Rod System Named without a submission number | |
| * | — | Biomet Brooker Femoral nail Named without a submission number | |
| * | — | Encore True/Flex Upper Extremity Nail Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083582 (Surgical Implant Generation Network (Sign), 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043200: Sign Fin Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043200
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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