510(k) · Cleared
Recalled · Class II · 2012Synthes (Usa) Retrograde/Antegrade Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 5, 2004 after a 79-day review. The FDA summary names its predicate without a number. 30 later devices descend from it. It has been recalled once.
- Decided
- Feb 5, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 0
30 later devices descend from it, 6 citing it directly.
- This deviceK033618 Synthes (Usa) Retrograde/Antegrade Femoral Nail SystemSynthes (Usa) · 2004
- Descendant · cites it directly · 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 · 3 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK201346 DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes…Synthes (USA) Products, LLC · 2020 · Recalled
- Descendant · 4 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · cites it directly15descendants
- K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on8descendants
- K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…Synthes (USA) Products, LLC · 2020 · cites it directly7descendants
- K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033618 | Synthes (Usa) Retrograde/Antegrade Femoral Nail System | Synthes (Usa) | 2004 | — |
| +1 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| +2 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +3 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| +1 | K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking… | Synthes (USA) Products, LLC | 2020 | 2 |
| +4 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | — | Synthes Distal Femoral Nail Named without a submission number | |
| * | — | Synthes Cannulated Femoral Nail Named without a submission number | |
| * | — | DePuy ACE ART Femoral Nail Named without a submission number |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111056 | Piccolo Composite Nailing System | 2011 | 15 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for… | 2020 | 7 |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | 2018 | 2 |
| K171108 | AUTOBAHN Nailing System | 2017 | 2 |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | 2024 | 1 |
| K091309 | Revolution Femoral Intramedullary Nail System, Model Dgooxx | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2012 | Class II | Z-2058-2013 | Packaging change control | Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111056 (CarboFix Orthopedics, Ltd., 2011) has gone furthest, with 15 descendants of its own.
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.
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?
Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
supracondylar fractures, including those with intra-articular extension
ipsilateral hip/shaft fractures
ipsilateral femur/tibia fractures
fernoral fractures in multiple trauma patients
fractures proximal to total knee arthroplasty
fractures distal to a hip implant
fractures in the morbidly obese
fractures in osteoporotic bone
impending pathologic fractures
malunions and nonunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033618
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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