510(k) · Cleared
ClearedDepuy Ace Universal and Troch Entry Femoral Nail Systems
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 Nov 14, 2003 as substantially equivalent to K871539 (Buckman Co., Inc., 1987) and 2 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1997. 53 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K970097 (1997). 6 ancestors in all, the oldest K871539 (1987). 53 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 2 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 1 generation backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- This deviceK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- Descendant · cites it directly · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- Descendant · cites it directly · 29 of its ownK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · 3 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 2 generations on · 16 of its ownK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · cites it directly39descendants
- K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · cites it directly29descendants
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 2 generations on17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 3 generations on16descendants
- K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −2 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −1 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| 0 (this device) | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| +1 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| +1 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| +2 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +3 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +2 | K091566 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2009 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K871539 | Zindrick IM RodSummary page 1…I1 DEVICE PRODUCT CODE: 87 HSB SUBSTANTIALLY EQUIVALENT DEVICES: DePuy ACE’ AIM Femoral Nail (K87 1539) DePuy ACE@Trochanteric Nail System (KO 10780) DePu… | 1987 |
| * | K010780 | Trochanteric NailSummary page 1…nail sizes include 8mm through 15mm diameters and lengths of 280mm through ~00nini. The Troch Entry Nail (TEN) is similar in design to the ACE@Trochanteric Nail System (K010780) and the ACE’ Long Trochanteric Nail System (KO13563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with… | 2001 |
| * | K013563 | Long Trochanteric Nail System | 2001 |
What descends from it? (53)
See all 536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails | 2009 | 39 |
| K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | 2010 | 29 |
| K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and… | 2009 | 3 |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | 2014 | 2 |
| K111663 | Trauma Internal Fixation Systems | 2012 | 1 |
| K111444 | Universal and Troch Entry Femoral Nailing Systems Line Extension | 2011 | 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 6 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K083497 (Zimmer, Inc., 2009) has gone furthest, with 39 descendants of its own.
- 2 other devices also cite its predicate K871539.
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® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of…
Read the full statement (201 words)
The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.
In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033329
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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