510(k) · Cleared
ClearedTalon Distalfix Proximal Femoral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Designs North America, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 22, 2011 as substantially equivalent to K043431 (Howmedica Osteonics Corp., 2005) and 4 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Aug 22, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K850886 (1985). 26 ancestors in all, the oldest K781762 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
- 3 generations backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
- 2 generations backK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
- 1 generation backK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
- This deviceK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850886 | Compression Hip Screw System | Pfizer, Inc. | 1985 | 1 |
| −3 | K955306 | Omega+ Compression Screw System | Howmedica Corp. | 1996 | 1 |
| −2 | K984331 | Odi Ultimate Compression Hip Screw | Orthopedic Designs, Inc. | 1999 | — |
| −1 | K033286 | Odi Talon Long Proximal Femoral Nail System | Orthopedic Designs, Inc. (Odi) | 2004 | — |
| 0 (this device) | K111352 | Talon Distalfix Proximal Femoral Nail | Orthopedic Designs North America, Inc. | 2011 | — |
| +1 | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K043431 | GAMMA3 Nail SystemSummary page 2…of manufacture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison: Stryker" Gamma3Tm Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) TalonM Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon TM Long… | 2005 |
| * | K034002 | GAMMA3 Nail SystemSummary page 2…cture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison: Stryker" Gamma3Tm Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) TalonM Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon TM Long Proximal… | 2004 |
| * | K032244 | Gamma 3 Nail SystemSummary page 2…method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison: Stryker" Gamma3Tm Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) TalonM Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon TM Long Proximal Femoral… | 2003 |
| * | K014189 | Odi Talon Intramedullary Hip NailSummary page 2…w will be provided in a pre- assembled condition with the deployable talons and end cap already installed. A similar Talon TM lag screw was previously cleared in 510(k)s K014189 and K033286. A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which m… | 2002 |
| * | K033286 | Odi Talon Long Proximal Femoral Nail SystemSummary page 2…ovided in a pre- assembled condition with the deployable talons and end cap already installed. A similar Talon TM lag screw was previously cleared in 510(k)s K014189 and K033286. A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used f… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | 2023 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- 8 of the 26 ancestors have a recall of any class.
- Of its descendants, K223933 (Exactech, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K043431.
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. 2011, 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 Talon Tm DistalFixrM Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111352: Talon Distalfix Proximal Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111352
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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