510(k) · Cleared
ClearedVan Hip Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epix Orthopaedic, Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 10, 2014 as substantially equivalent to K032244 (Howmedica Osteonics Corp., 2003) and 2 other predicates after a 161-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 10, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970097 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −1 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| 0 (this device) | K133104 | Van Hip Fracture System | Epix Orthopaedic, Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K032244 | Gamma 3 Nail SystemSummary page 1…variations in the femoral neck angle. Predicate Device: The VAN Hip Fracture System is substantially equivalent to the Stryker Howmedica Osteonics Gamma 3 Nail System (K032244), Biomet Vani-Angle Hip Screw (VHS) Sj'stem (K964880), and Disc-O-Tech Fixion Nail (K010988).… | 2003 |
| * | K964880 | Vari-Angle Hip Screw (VHS) SystemSummary page 1…ice: The VAN Hip Fracture System is substantially equivalent to the Stryker Howmedica Osteonics Gamma 3 Nail System (K032244), Biomet Vani-Angle Hip Screw (VHS) Sj'stem (K964880), and Disc-O-Tech Fixion Nail (K010988).… | 1997 |
| * | K010988 | Fixion Interlocking Proximal Femoral Nailing SystemSummary page 1…stantially equivalent to the Stryker Howmedica Osteonics Gamma 3 Nail System (K032244), Biomet Vani-Angle Hip Screw (VHS) Sj'stem (K964880), and Disc-O-Tech Fixion Nail (K010988). 24… | 2001 |
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 17 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 6 other devices also cite its predicate K032244.
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. 2014, 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 VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133104: Van Hip Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133104
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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