510(k) · Cleared
ClearedDepuy Ace Aim (R) Titanium Supracondylar Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 10, 1998 after a 78-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.
- Decided
- Mar 10, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 2 citing it directly.
- This deviceK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
- 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 · 2 generations on · 15 of its ownK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · 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
- K050882Newdeal Ankle NailNew Deal, S.A. · 2005 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974781 | Depuy Ace Aim (R) Titanium Supracondylar Nail | Depuy, Inc. | 1998 | — |
| +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 | — |
| +2 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | ACE Medical AIM® Titanium Supracondylar Nail Named without a submission number | |
| * | — | Smith & Nephew Orthopaedics Richards Supracondylar Nail System Named without a submission number |
What descends from it? (43)
See all 432 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 AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intra-articular involvement, osteoporosis, nonunions, malunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and…
Read the full statement (103 words)
The AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intra-articular involvement, osteoporosis, nonunions, malunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated 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 (Tibio Calcaneal Arthrodesis); Post traumatic/primary arthrosis involving both ankle and subtalar joints; A rheumatoid hindfoot; Avascular necrosis of the talus; Previously infected arthrosis, second degree; Failed total arthroplasty.
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/K974781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974781: Depuy Ace Aim (R) Titanium Supracondylar Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974781
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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