510(k) · Cleared
ClearedCannulated Femoral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDN Implant, Fixation Device, Spinal
Cleared on Mar 8, 1996 after a 137-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 137 days
- Class
- Class II
- Product code
- JDN
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 4 citing it directly.
- This deviceK954856 Cannulated Femoral NailSynthes (Usa) · 1996
- Descendant · cites it directly · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 3 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 2 generations on15descendants
- K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954856 | Cannulated Femoral Nail | Synthes (Usa) | 1996 | — |
| +1 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +2 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| +2 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +3 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 JDN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Synthes Unreamed Femoral Nail (URFN) Named without a submission number |
What descends from it? (32)
See all 324 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, K102369 (N.M.B. Medical Applications, Ltd., 2011) has gone furthest, with 16 descendants of its own.
How does its category compare?
All JDN devicesJDN Implant, Fixation Device, Spinal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDN
FDA has decided no JDN device since 2007.
Median 510(k) review, days · JDN
Too few JDN 510(k)s in any year since 2007 to give a median.
Recalls per year · JDN
No recall names JDN since 2007.
Adverse event reports per year · JDN
1in 2024
MAUDE reports naming product code JDN, 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 | 0 | — | 0 | 77 |
| 2008 | 0 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 56 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 64 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.
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/K954856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954856: Cannulated 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/K954856
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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