510(k) · Cleared
ClearedOdi Talon Intramedullary Hip Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Designs, Inc. · JDS Nail, Fixation, Bone
Cleared on Mar 21, 2002 after a 90-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Mar 21, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK014189 Odi Talon Intramedullary Hip NailOrthopedic Designs, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
- Descendant · cites it directly · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · cites it directly2descendants
- K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · cites it directly1descendant
- K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014189 | Odi Talon Intramedullary Hip Nail | Orthopedic Designs, Inc. | 2002 | — |
| +1 | K033286 | Odi Talon Long Proximal Femoral Nail System | Orthopedic Designs, Inc. (Odi) | 2004 | — |
| +1 | K111352 | Talon Distalfix Proximal Femoral Nail | Orthopedic Designs North America, Inc. | 2011 | — |
| +2 | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K033286 (Orthopedic Designs, Inc. (Odi), 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ODi Talon™ Intramedullary Hip Nail will be used on indications that are common with presently marketed intramedullary hip nail systems. The primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
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/K014189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014189: Odi Talon Intramedullary Hip Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014189
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026