510(k) · Cleared
ClearedVertex Hip Fracture Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthoxel Dac · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Apr 4, 2024 as substantially equivalent to K183162 (Biomet, Inc., 2018) and 1 other predicate after a 114-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Apr 4, 2024
- Review
- 114 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970097 (1997). 17 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 4 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 3 generations backK042325 Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2004 · Recalled
- 2 generations backK100238 HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125…DePuy Orthopaedics, Inc. · 2010 · Recalled
- 1 generation backK183162 Affixus Hip Fracture NailBiomet, Inc. · 2018
- This deviceK233910 Vertex Hip Fracture Nailing SystemOrthoxel Dac · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −5 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −4 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −3 | K042325 | Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2004 | 11 |
| −2 | 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 |
| −1 | K183162 | Affixus Hip Fracture Nail | Biomet, Inc. | 2018 | — |
| 0 (this device) | K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K183162 | Affixus Hip Fracture NailSummary page 5…Class: II 6. Predicate Devices The Vertex Hip Fracture Nailing System is substantially equivalent to the primary predicate, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), and the TriGen InterTAN (K040212) with respect to intended use, technological characteristics, and performance data. === Page… | 2018 |
| * | K040212 | Trigen IntertanSummary page 5…Vertex Hip Fracture Nailing System is substantially equivalent to the primary predicate, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), and the TriGen InterTAN (K040212) with respect to intended use, technological characteristics, and performance data.… | 2004 |
| † | K181375 | Apex Femoral Nailing System | 2018 |
| † | K170972 | Apex Tibial Nailing System | 2017 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 10 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K183162.
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. 2024, 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?
The Vertex Hip Fracture Nailing System is intended for temporary fixation and stabilization of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of: • Pertrochanteric fractures; • Intertrochanteric fractures; • High subtrochanteric fractures • Combinations of the above fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated for…
Read the full statement (117 words)
The Vertex Hip Fracture Nailing System is intended for temporary fixation and stabilization of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
• Pertrochanteric fractures;
• Intertrochanteric fractures;
• High subtrochanteric fractures
• Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
• 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/K233910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233910: Vertex Hip Fracture Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233910
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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