510(k) · Cleared
ClearedDePuy Synthes Femoral Recon Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 14, 2017 as substantially equivalent to K040336 (Synthes (Usa), 2004) and 2 other predicates after a 119-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Nov 14, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981529 (1998). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 1 generation backK040462 Trigen Trochanteric Antegrade NailSmith & Nephew, Inc. · 2004 · Recalled
- This deviceK172157 DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC · 2017
- Descendant · cites it directly · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK261043 AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −1 | K040462 | Trigen Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2004 | 2 |
| 0 (this device) | K172157 | DePuy Synthes Femoral Recon Nail System | Synthes (USA) Products, LLC | 2017 | — |
| +1 | K220659 | AUTOBAHN (R) EVO Femoral Nails | Globus Medical, Inc. | 2022 | — |
| +2 | K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 4…21 CFR 888.3020 Product Code: HSB Primary Predicate Device: Synthes Lateral Entry Femoral Nail System (K040336) Predicate Devices Additional Predicate Device: Synthes Adolescent Lateral Entry Fem… | 2004 |
| * | K070843 | Synthes Adolescent Lateral Entry Femoral Nail SystemSummary page 4…l Nail System (K040336) Predicate Devices Additional Predicate Device: Synthes Adolescent Lateral Entry Femoral Nail System (K070843) Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462) The Femoral Recon Nail (… | 2007 |
| * | K040462 | Trigen Trochanteric Antegrade NailSummary page 4…ate Device: Synthes Adolescent Lateral Entry Femoral Nail System (K070843) Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462) The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing implants… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220659 | AUTOBAHN (R) EVO Femoral Nails | 2022 | 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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K220659 (Globus Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K040336.
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. 2017, 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 Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
- Subtrochanteric fractures
- Ipsilateral neck/shaft fracturcs
- Femoral shaft fractures
- Impending pathologic fractures
- Malunions and nonunions
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/K172157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172157: DePuy Synthes Femoral Recon Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172157
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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