510(k) · Cleared
ClearedUltimax Ankle Fusion Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 6, 1999 after a 72-day review. The FDA summary names no predicate by number. 54 later devices descend from it.
- Decided
- Aug 6, 1999
- Review
- 72 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 3 citing it directly.
- This deviceK991790 Ultimax Ankle Fusion Rod SystemEncore Orthopedics, Inc. · 1999
- Descendant · cites it directly · 41 of its ownK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
- Descendant · 2 generations on · 25 of its ownK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
- Descendant · 2 generations on · 24 of its ownK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
- Descendant · 3 generations on · 22 of its ownK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
- Descendant · cites it directly · 18 of its ownK081243 Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K023115Ace VersanailDePuy Orthopaedics, Inc. · 2002 · cites it directly41descendants
- K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions · 2011 · 2 generations on25descendants
- K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012 · 2 generations on24descendants
- K171376DynaNail TTC Fusion SystemMedShape, Inc. · 2017 · 3 generations on22descendants
- K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991790 | Ultimax Ankle Fusion Rod System | Encore Orthopedics, Inc. | 1999 | — |
| +1 | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
| +2 | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… | Medshape Solutions | 2011 | — |
| +2 | K113828 | Dynanail Ankle Arthrodesis Nail | MedShape, Inc. | 2012 | — |
| +3 | K171376 | DynaNail TTC Fusion System | MedShape, Inc. | 2017 | — |
| +1 | K081243 | Biomet Phoenix Ankle Nail System | Biomet Trauma | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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?
The FDA summary names no predicate by number.
What descends from it? (54)
See all 543 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, K023115 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 41 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 UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.
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/K991790 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991790: Ultimax Ankle Fusion Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991790
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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