510(k) · Cleared
ClearedSign IM 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 Sep 23, 2002 as substantially equivalent to K010801 (Howmedica Osteonics Corp., 2001) and 2 other predicates after a 47-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Sep 23, 2002
- Review
- 47 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K972108 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972108 Alta Intramedullary Rod SystemHowmedica Corp. · 1997
- This deviceK022632 Sign IM NailSurgical Implant Generation Network (Sign) · 2002
- Descendant · cites it directly · 0 of its ownK163589 SIGN IM NailSign Fracture Care International · 2017
- Descendant · cites it directly · 0 of its ownK152757 SIGN Hip Construct (SHC)Sign Fracture Care International · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972108 | Alta Intramedullary Rod System | Howmedica Corp. | 1997 | — |
| 0 (this device) | K022632 | Sign IM Nail | Surgical Implant Generation Network (Sign) | 2002 | — |
| +1 | K163589 | SIGN IM Nail | Sign Fracture Care International | 2017 | — |
| +1 | K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K010801 | T2 Femoral Nail | 2001 |
| * | K021026 | S2 Femoral Nail | 2002 |
| * | K972108 | Alta Intramedullary Rod SystemSummary page 1…edicate femoral nailing devices: 1. Howmedica T2TM Femoral Nail #KO 10801 2. Howmedica S2TM Femoral Nail #KO21026 3. Howmedica AltaB Femoral IM Rod #K972108 All of the devices listed above are similar in design, material, intended use and method of application to the SIGN IM Nail sys… | 1997 |
What descends from it? (2)
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?
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 IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022632: Sign IM Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022632
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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