510(k) · Cleared
Recalled · Class II · 2018HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM
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 May 11, 2010 as substantially equivalent to K042325 (DePuy Orthopaedics, Inc., 2004) and 1 other predicate after a 104-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it. It has been recalled 250 times.
- Decided
- May 11, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 250
- Predicates
- 2
Its longest line of descent runs back 4 generations to K970097 (1997). 11 ancestors in all, the oldest K871539 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 3 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 2 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 1 generation backK042325 Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2004 · Recalled
- This deviceK100238 HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125…DePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · cites it directly · 2 of its ownK183162 Affixus Hip Fracture NailBiomet, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK230071 Femur Reconstruction Interlocking Nail System, Femur Retrograde…Tdm Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK233910 Vertex Hip Fracture Nailing SystemOrthoxel Dac · 2024
- Descendant · 2 generations on · 0 of its ownK221489 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
2011high 2 (2024) · low 0 (2012)2026
Most influential descendants
Showing 5 of 7 · See all- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · cites it directly2descendants
- K183162Affixus Hip Fracture NailBiomet, Inc. · 2018 · cites it directly2descendants
- K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd. · 2024 · 2 generations on0descendants
- K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac · 2024 · 2 generations on0descendants
- K221489Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −3 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −2 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −1 | K042325 | Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2004 | 11 |
| 0 (this device) | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +1 | K183162 | Affixus Hip Fracture Nail | Biomet, Inc. | 2018 | — |
| +2 | K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking… | Tdm Co., Ltd. | 2024 | — |
| +2 | K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | 2024 | — |
| +2 | K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K042325 | Trochanteric Nail SystemSummary page 1…acture Nail System is substantially equivalent to currently marketed devices: Trochanteric Nail System (K042325) and Gamma3 Nail System (K043431). Device Description: The Hip Fracture Nail System consists of an intrameduilary… | 2004 |
| * | K043431 | GAMMA3 Nail SystemSummary page 1…ly equivalent to currently marketed devices: Trochanteric Nail System (K042325) and Gamma3 Nail System (K043431). Device Description: The Hip Fracture Nail System consists of an intrameduilary na… | 2005 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2018 | Class II | Z-0449-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0452-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0447-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0454-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0453-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0451-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0448-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Oct 2, 2018 | Class II | Z-0450-2019 | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. |
| Aug 8, 2018 | Class II | Z-0164-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0140-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0151-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0150-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0134-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0139-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0146-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0152-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0157-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0166-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0168-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0124-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0129-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0155-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0154-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0158-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0161-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0163-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0149-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0133-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0159-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0137-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0138-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0136-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0142-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0126-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0156-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0141-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0165-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0148-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0167-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0153-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0169-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0128-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0130-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0125-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0123-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0162-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0131-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0143-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0122-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Aug 8, 2018 | Class II | Z-0144-2019 | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 8 of the 11 ancestors have a recall of any class.
- Of its descendants, K192003 (Auxein Medical Private Limited, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K042325.
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. 2010, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2007high 23 (2017) · low 8 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
2007high 195 (2024) · low 57 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
2007high 81 (2009) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
2007high 4,111 (2021) · low 162 (2007)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 Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100238: HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100238
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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