510(k) · Cleared
ClearedProximal Femoral Nail (PFN) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDW Pin, Fixation, Threaded
Cleared on Mar 13, 1997 after a 59-day review. The FDA summary names its predicate without a number. 184 later devices descend from it.
- Decided
- Mar 13, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
184 later devices descend from it, 8 citing it directly.
- This deviceK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- Descendant · cites it directly · 73 of its ownK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- Descendant · cites it directly · 71 of its ownK983814 Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999
- Descendant · 2 generations on · 70 of its ownK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- Descendant · cites it directly · 59 of its ownK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- Descendant · 2 generations on · 56 of its ownK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997 · cites it directly73descendants
- K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999 · cites it directly71descendants
- K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · 2 generations on70descendants
- K010988Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · cites it directly59descendants
- K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 2001 · 2 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| +1 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| +1 | K983814 | Gotfried Percutaneous Compression Plating System | Efratgo, Ltd. HI Tech Bio-Surgical | 1999 | — |
| +2 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| +1 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| +2 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 14 | 0 |
| 2025 | 17 | 0 |
| 2026 | 12 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 |
|---|---|---|---|
| * | — | Howmedica’s Gamma Locking Nail (GLN) Named without a submission number |
What descends from it? (184)
See all 1848 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | 1997 | 73 |
| K983814 | Gotfried Percutaneous Compression Plating System | 1999 | 71 |
| K010988 | Fixion Interlocking Proximal Femoral Nailing System | 2001 | 59 |
| K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail | 2014 | 10 |
| K192003 | Auxein Nailing System | 2020 | 2 |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | 2018 | 2 |
| K043233 | Gotfried Physiological Hip (PH) Nail | 2005 | 1 |
| K021782 | BNF | 2002 | 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?
- Of its descendants, K973240 (Synthes (Usa), 1997) has gone furthest, with 73 descendants of its own.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synthes PFN System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fiacturcs high subtrochanteric fractures, and combinations of these 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/K970097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970097: Proximal Femoral Nail (PFN) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970097
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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