510(k) · Cleared
ClearedOrthofix Femoral Nailing Sytem
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 19, 1997 as substantially equivalent to K961027 (Orthofix, Inc., 1996) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Dec 19, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912420 (1991). 4 ancestors in all, the oldest K860756 (1986). 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 | K912420 | Orthofix Unreamed Tibial Nail System | Scientific Research | 1991 | — |
| −1 | K961027 | Orthofix Tibial Nailing System | Orthofix, Inc. | 1996 | — |
| 0 (this device) | K973944 | Orthofix Femoral Nailing Sytem | Orthofix Srl | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 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 |
|---|---|---|---|
| * | K961027 | Orthofix Tibial Nailing SystemSummary page 2…lly distribute its Femoral Nailing System for the first time in the U.S. Orthofix currently distributes a comparable nailing system for the tibia, Tibial Nailing System (K961027). Like our tibial nailing system and predicate devices our femoral nailing system includes a series of nails of varying diameters… | 1996 |
| * | K860756 | Grosse and Kempf Locking Nail System, Non-Slot RodSummary page 3…are substantially equivalent to those provided in the predicate systems. Two such predicate devices are the Howmedica Grosse & Kempf Locking Nail System (K860756) and Smith & Nephew Richards Femoral Interlocking Nail System. The Orthofix Femoral Nailing System and the legally marketed predi… | 1986 |
| * | — | Smith & Nephew Richards Femoral Interlocking Nail System Named without a submission number |
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 6 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
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.
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 Femoral Nailing System is indicated
for the following: traumatic fractures; pathological
fractures; refractures; non-unions;, reconstructive
surgery; and bone transport.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973944: Orthofix Femoral Nailing Sytem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973944
Report an extraction error
Are you the manufacturer?
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