510(k) · Cleared

Cleared

Synthes Proximal Femoral Nail (PFN) System Modification

K973240510(k) TraditionalCleared Nov 20, 199784-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · HTY Pin, Fixation, Smooth

Cleared on Nov 20, 1997 as substantially equivalent to K970097 (Synthes (Usa), 1997) after an 84-day review. Its family tree reaches back 1 generation to 1997. 73 later devices descend from it.

Decided: Nov 20, 1997
Review: 84 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970097 (1997). 73 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
This deviceK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
Descendant · cites it directly · 70 of its ownK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
Descendant · 2 generations on · 53 of its ownK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
Descendant · 3 generations on · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
Descendant · 3 generations on · 29 of its ownK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
Descendant · 4 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2001high 8 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 73 · See all

K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly70descendants
K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003 · 2 generations on53descendants
K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · 3 generations on39descendants
K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · 3 generations on29descendants
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 4 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970097	Proximal Femoral Nail (PFN) System	Synthes (Usa)	1997	—
0 (this device)	K973240	Synthes Proximal Femoral Nail (PFN) System Modification	Synthes (Usa)	1997	—
+1	K013563	Long Trochanteric Nail System	DePuy Orthopaedics, Inc.	2001	54
+2	K033329	Depuy Ace Universal and Troch Entry Femoral Nail Systems	Depuy, Inc.	2003	—
+3	K083497	Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…	Zimmer, Inc.	2009	16
+3	K101622	Zimmer Natural Nail System Retrograde Femoral Nails	Zimmer, Inc.	2010	3
+4	K172774	T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…	Stryker Trauma GmbH	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	2	0
2009	3	0
2010	3	0
2011	2	0
2012	3	0
2013	2	0
2014	3	0
2015	1	0
2017	2	0
2018	7	0
2019	4	0
2020	5	0
2021	3	0
2022	6	0
2023	6	0
2024	5	0
2025	8	0
2026	5	0

FIG. 1 — Lineage of K973240, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HTY? 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 HTY device

#1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K970097	Proximal Femoral Nail (PFN) System Summary page 1 …, PA 19301 (610) 647-9700 Contact: Sheri L. Musgnung Nail, Fixation, Bone Pin, Fixation, Threaded Class II, 21 CFR 888.3020; 888.3040 Synthes Proximal Femoral Nail (K970097) Synthes modified PFN System is a cannulated intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and a…	Synthes (Usa)	1997	—

Also cleared against K970097: 7 other devices →

What descends from it? (73)

See all 73

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013563	Long Trochanteric Nail System	DePuy Orthopaedics, Inc.	2001	70
K093707	Dyna Locking Trochanteric Nail, Model NG0820	U&I Corp.	2010	1

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?

Its one ancestor has no recall.
Of its descendants, K013563 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 70 descendants of its own.
7 other devices also cite its predicate K970097.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

What is it indicated for?

The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.

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/K973240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973240: Synthes Proximal Femoral Nail (PFN) System Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973240

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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