510(k) · Cleared
Recalled · Class II · 2018Depuy Ace a.I.M. Titanium Tibial Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Co. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 26, 1997 after a 77-day review. The FDA summary names its predicate without a number. 49 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 0
49 later devices descend from it, 1 citing it directly.
- This deviceK972183 Depuy Ace a.I.M. Titanium Tibial NailAce Medical Co. · 1997
- Descendant · cites it directly · 48 of its ownK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001
- Descendant · 2 generations on · 47 of its ownK032097 Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003
- Descendant · 3 generations on · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 5 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly48descendants
- K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003 · 2 generations on47descendants
- K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · 3 generations on35descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 4 generations on16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972183 | Depuy Ace a.I.M. Titanium Tibial Nail | Ace Medical Co. | 1997 | — |
| +1 | K013430 | Ace Bio Win Tibial Nailing System | DePuy Orthopaedics, Inc. | 2001 | — |
| +2 | K032097 | Depuy Ace Versanail Tibial Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| +3 | K082770 | Zimmer Natural Nail System Tibial Nail | Zimmer, Inc. | 2008 | 15 |
| +4 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +5 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 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? (3)
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 |
|---|---|---|---|
| * | — | DePuy ACE A.I.M.® Titanium Tibial Nail Named without a submission number | |
| * | — | Synthes Reamed Titanium Tibial Nail Named without a submission number | |
| * | — | Synthes Unreamed Titanium Tibial Nail Named without a submission number |
What descends from it? (49)
See all 491 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013430 | Ace Bio Win Tibial Nailing System | 2001 | 48 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2018 | Class II | Z-1197-2018 | Under Investigation by firm | The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system. |
| Feb 6, 2018 | Class II | Z-1196-2018 | Under Investigation by firm | The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013430 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 48 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 DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.
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/K972183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972183: Depuy Ace a.I.M. Titanium Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972183
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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