510(k) · Cleared
ClearedAlta Intramedullary Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 12, 1997 after a 68-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 12, 1997
- Review
- 68 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK972108 Alta Intramedullary Rod SystemHowmedica Corp. · 1997
- Descendant · cites it directly · 2 of its ownK022632 Sign IM NailSurgical Implant Generation Network (Sign) · 2002
- Descendant · 2 generations on · 0 of its ownK163589 SIGN IM NailSign Fracture Care International · 2017
- Descendant · 2 generations on · 0 of its ownK152757 SIGN Hip Construct (SHC)Sign Fracture Care International · 2015
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 |
|---|---|---|---|---|---|
| 0 (this device) | K972108 | Alta Intramedullary Rod System | Howmedica Corp. | 1997 | — |
| +1 | K022632 | Sign IM Nail | Surgical Implant Generation Network (Sign) | 2002 | — |
| +2 | K163589 | SIGN IM Nail | Sign Fracture Care International | 2017 | — |
| +2 | K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | — | Howmedica's Alta® IM Rod System Named without a submission number | |
| * | — | Alta® CFX Reconstruction Rod Named without a submission number | |
| * | — | Richard’s TriMax Nail System Named without a submission number | |
| * | — | ACE Medical's ART™ Femoral Nail System Named without a submission number | |
| * | — | Biomet's Retrograde Femoral Nail Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022632 | Sign IM Nail | 2002 | 2 |
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, K022632 (Surgical Implant Generation Network (Sign), 2002) 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 Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. They can be used in procedures such as femoral reconstruction, bone lengthening/shortening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.
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/K972108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972108: Alta Intramedullary Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972108
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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