510(k) · Cleared
ClearedDepuy Synthes Femoral Neck System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 16, 2018 as substantially equivalent to K112406 (Smith & Nephew, Inc., 2011) and 2 other predicates after a 68-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Oct 16, 2018
- Review
- 68 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981372 (1998). 21 ancestors in all, the oldest K791619 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
- 1 generation backK112406 Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc. · 2011
- This deviceK182154 Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC · 2018
- Descendant · cites it directly · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 1 of 1 · See all- K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | Smith & Nephew, Inc. | 2007 | — |
| −1 | K112406 | Peri-Loc Proximal Femur Locking Bone Plates | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K182154 | Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC | 2018 | — |
| +1 | K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 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 |
|---|---|---|---|
| * | K112406 | Peri-Loc Proximal Femur Locking Bone PlatesSummary page 4…Number: 21 CFR 888.3030 Product Code: KTT Primary predicate Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406) device Stryker Omega 3 System (K062066) Predicate device DePuy Synthes Femoral… | 2011 |
| * | K062066 | Omega 3 SystemSummary page 4…T Primary predicate Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406) device Stryker Omega 3 System (K062066) Predicate device DePuy Synthes Femoral Neck System (K172872) Reference device Asnis III 6.5mm C… | 2006 |
| * | K172872 | DePuy Synthes Femoral Neck SystemSummary page 4…cking Bone Plates (K112406) device Stryker Omega 3 System (K062066) Predicate device DePuy Synthes Femoral Neck System (K172872) Reference device Asnis III 6.5mm Cannulated Screw (K024060) The subject Femoral Neck System is… | 2018 |
| † | K024060 | Modification to Asnis Iii Cannulated Screw System | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | 2023 | 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K230764 (OsteoCentric Technologies, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112406.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.
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/K182154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182154: Depuy Synthes Femoral Neck System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182154
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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