510(k) · Cleared
ClearedAscension Ankle Fusion Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 12, 2010 as substantially equivalent to K091976 (Biomet Trauma, 2009) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Jul 12, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K051590 (2005). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051590 | T2 Ankle Arthrodesis Nail | Howmedica Osteonics Corp. | 2005 | 8 |
| 0 (this device) | K100925 | Ascension Ankle Fusion Nail System | Ascension Orthopedics, Inc. | 2010 | — |
| +1 | K163627 | Shotel Ankle Arthrodesis Nail System | Biopro, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K091976 | Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailSummary page 1…Fixation, Intramnedullary And Accessories PRODUCT CODE: HSIB PANEL: Orthopedic PREDICATE DEVICES: K091976 - Biomet Ankle Arthrodesis Nail, Biomet Phoenix Ankle Nail System K051590 - Stryker T2 Ankle Arthrodesis Nail DEVICE DESCRIPTION… | 2009 |
| * | K051590 | T2 Ankle Arthrodesis NailSummary page 1…RODUCT CODE: HSIB PANEL: Orthopedic PREDICATE DEVICES: K091976 - Biomet Ankle Arthrodesis Nail, Biomet Phoenix Ankle Nail System K051590 - Stryker T2 Ankle Arthrodesis Nail DEVICE DESCRIPTION: The Ascension® Ankle Fusion Nail System is to be implanted by insertion… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail System | 2017 | 0 |
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. 2010, this device’s year, is highlighted.
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 Ascension® Ankle Fusion Nail System is intended for the following:
* Charcot Foot
* Avascular necrosis of the talus
* Failed total ankle arthroplasty
* Trauma (malunited tibial pilon fracture)
* Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
* Revision ankle arthrodesis
* Neuroarthropathy
* Rheumatoid arthritis
* Osteoarthritis
* Pseudoarthrosis
* Post-Traumatic arthrosis
* Previously infected arthrosis
* Severe end stage degenerative arthritis
* Severe defects after tumor resection
* Pantalar arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100925: Ascension Ankle Fusion Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100925
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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