510(k) · Cleared
ClearedAce Versanail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 18, 2002 as substantially equivalent to K974781 (Depuy, Inc., 1998) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1998. 41 later devices descend from it.
- Decided
- Dec 18, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K974781 (1998). 5 ancestors in all. 41 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
- This deviceK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 25 of its ownK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
- Descendant · cites it directly · 24 of its ownK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
- Descendant · 2 generations on · 22 of its ownK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
- Descendant · cites it directly · 15 of its ownK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
- Descendant · cites it directly · 14 of its ownK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions · 2011 · cites it directly25descendants
- K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012 · cites it directly24descendants
- K171376DynaNail TTC Fusion SystemMedShape, Inc. · 2017 · 2 generations on22descendants
- K050882Newdeal Ankle NailNew Deal, S.A. · 2005 · cites it directly15descendants
- K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974781 | Depuy Ace Aim (R) Titanium Supracondylar Nail | Depuy, Inc. | 1998 | — |
| 0 (this device) | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… | Medshape Solutions | 2011 | — |
| +1 | K113828 | Dynanail Ankle Arthrodesis Nail | MedShape, Inc. | 2012 | — |
| +2 | K171376 | DynaNail TTC Fusion System | MedShape, Inc. | 2017 | — |
| +1 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
| +1 | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K974781 | Depuy Ace Aim (R) Titanium Supracondylar NailSummary page 1…ixation, Intramedullary and Accessories Device Product Code: 87HSB Substantially Equivalent Devices: ACE@AIM@Titanium Supracondylar Nail K974781 ACE@AIM@TTC Fusion Nail KO03797… | 1998 |
| * | K003797 | Ace Aim TTC Fusion Nail | 2000 |
| * | K982953 | Titanium Intramedullary Nails-Various StylesSummary page 1…ACE@AIM@TTC Fusion Nail KO03797 Biomet Ankle Arthrodesis Nail K982953 Encore@UltiMax Ankle Fusion Rod K991790… | 1998 |
| * | K991790 | Ultimax Ankle Fusion Rod SystemSummary page 1…Biomet Ankle Arthrodesis Nail K982953 Encore@UltiMax Ankle Fusion Rod K991790 Smith and Nephew Intramedullary Nail K983942 Device Description:… | 1999 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 1…Encore@UltiMax Ankle Fusion Rod K991790 Smith and Nephew Intramedullary Nail K983942 Device Description: The VersaNailm is a straight, cannulated intramedullary nail… | 1998 |
What descends from it? (41)
See all 417 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222… | 2011 | 25 |
| K113828 | Dynanail Ankle Arthrodesis Nail | 2012 | 24 |
| K050882 | Newdeal Ankle Nail | 2005 | 15 |
| K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | 2009 | 14 |
| K070761 | Sanatmetal Nails and Pins | 2008 | 3 |
| K121575 | Oxford Ankle Fusion Nail (Afn) System | 2012 | 1 |
| K111663 | Trauma Internal Fixation Systems | 2012 | 1 |
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 VersaNail is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023115: Ace Versanail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023115
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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