510(k) · Cleared
ClearedORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 7, 2017 as substantially equivalent to K161466 (Orthofix Srl, 2017) after a 30-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 7, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013468 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- 3 generations backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- 2 generations backK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- 1 generation backK161466 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017
- This deviceK173458 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| −3 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| −2 | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| −1 | K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl | 2017 | — |
| 0 (this device) | K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemSummary page 4…Product Code HSB Name of Predicate Device 510(k) # Manufacturer ORTHOFIX CHIMAERA Hip K161466 Orthofix Srl Fracture System - Trochanteric Nailing System Description The ORTHO… | 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 16 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
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. 2017, 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 ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization and fixation of various types of fractures or deformities. The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures…
Read the full statement (99 words)
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization and fixation of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10 cm proximal to the intercondylar notch. These includes traumatic fractures, refractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173458: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric 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/K173458
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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