510(k) · Cleared
ClearedDepuy Ace Versanail Tibial Nail
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 Aug 8, 2003 as substantially equivalent to K013430 (DePuy Orthopaedics, Inc., 2001) after a 31-day review. Its family tree reaches back 2 generations to 1992. 47 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914453 (1992). 4 ancestors in all. 47 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK914453 Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa) · 1992
- 1 generation backK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001
- This deviceK032097 Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 3 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- Descendant · cites it directly · 11 of its ownK080706 Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · cites it directly35descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 3 generations on15descendants
- K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · cites it directly11descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914453 | Universal Tibial Nail and Unreamed Tibial Nail | Synthes (Usa) | 1992 | — |
| −1 | K013430 | Ace Bio Win Tibial Nailing System | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K032097 | Depuy Ace Versanail Tibial Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K082770 | Zimmer Natural Nail System Tibial Nail | Zimmer, Inc. | 2008 | 15 |
| +2 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +3 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| +1 | K080706 | Connexx Locking Tibia Nail | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | — |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K013430 | Ace Bio Win Tibial Nailing System | 2001 |
What descends from it? (47)
See all 476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082770 | Zimmer Natural Nail System Tibial Nail | 2008 | 35 |
| K080706 | Connexx Locking Tibia Nail | 2008 | 11 |
| K070444 | Aos Tibial Nail | 2007 | 4 |
| K150867 | Affixus Tibial Nailing System | 2015 | 3 |
| K111663 | Trauma Internal Fixation Systems | 2012 | 1 |
| K172189 | Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &… | 2018 | 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K082770 (Zimmer, Inc., 2008) has gone furthest, with 35 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 Tibial Nail is intended for bone fixation in the management of fractures and reconstructive
surgeries.
Non-weight bearing bone fixation is indicated in the following conditions:
Transverse, oblique, spiral, segmental and comminuted fractures;
Fractures with bone loss and bone transport;
Open fractures, pathologic fractures;
Corrective osteotomies;
Pseudarthrosis of the tibial shaft;
Nonunions, malunions, metaphyseal and epiphyseal fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032097: Depuy Ace Versanail Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032097
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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