510(k) · Cleared
ClearedUniversal and Troch Entry Femoral Nailing Systems Line Extension
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 Jun 22, 2011 as substantially equivalent to K033329 (Depuy, Inc., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jun 22, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970097 (1997). 13 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 2 generations backK042325 Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2004 · Recalled
- 1 generation backK100238 HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125…DePuy Orthopaedics, Inc. · 2010 · Recalled
- This deviceK111444 Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −3 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −2 | K042325 | Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2004 | 11 |
| −1 | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM | DePuy Orthopaedics, Inc. | 2010 | 250 |
| 0 (this device) | K111444 | Universal and Troch Entry Femoral Nailing Systems Line Extension | DePuy Orthopaedics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsSummary page 1…cessories Name of The device is substantially equivalent to the currently marketed DePuy Predicate Universal and Troch Entry Femoral Nailing Systems, K033329 and the Hip Devices Fracture Nail, K100238. Classification Class 11,21 CFR 885.3020, product code HSB Performanc… | 2003 |
| * | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMSummary page 1…ally equivalent to the currently marketed DePuy Predicate Universal and Troch Entry Femoral Nailing Systems, K033329 and the Hip Devices Fracture Nail, K100238. Classification Class 11,21 CFR 885.3020, product code HSB Performance Performance standards have not been establish… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 13 ancestors have a recall of any class.
- 5 other devices also cite its predicate K033329.
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. 2011, this device’s year, is highlighted.
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?
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…
Read the full statement (192 words)
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 features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trohchanteric 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/K111444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111444: Universal and Troch Entry Femoral Nailing Systems Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111444
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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