510(k) · Cleared
Recalled · Class II · 2013Synthes (Usa) Cannulated Titanium Humeral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDS Nail, Fixation, Bone
Cleared on Nov 5, 2003 after a 37-day review. The FDA summary names no predicate by number. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 5, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- JDS
- Recalls
- 2
- Predicates
- 0
21 later devices descend from it, 6 citing it directly.
- This deviceK033071 Synthes (Usa) Cannulated Titanium Humeral Nail SystemSynthes (Usa) · 2003
- Descendant · cites it directly · 17 of its ownK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
- Descendant · cites it directly · 15 of its ownK120807 Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 3 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · cites it directly · 2 of its ownK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · cites it directly17descendants
- K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012 · cites it directly15descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 3 generations on3descendants
- K192003Auxein Nailing SystemAuxein Medical Private Limited · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033071 | Synthes (Usa) Cannulated Titanium Humeral Nail System | Synthes (Usa) | 2003 | — |
| +1 | K103002 | Synthes Multiloc Proximal Humeral Nailing System | Synthes (Usa) | 2011 | 2 |
| +1 | K120807 | Synthes Multiloc Humeral Nailing System | Synthes USA Products, LLC | 2012 | — |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +3 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +1 | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103002 | Synthes Multiloc Proximal Humeral Nailing System | 2011 | 17 |
| K120807 | Synthes Multiloc Humeral Nailing System | 2012 | 15 |
| K192003 | Auxein Nailing System | 2020 | 2 |
| K173255 | Talon DistalFix Humeral Nail | 2018 | 1 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 0 |
| K141737 | Conventus PHS System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2013 | Class II | Z-0407-2014 | Pending | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. |
| 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, K103002 (Synthes (Usa), 2011) has gone furthest, with 17 descendants of its own.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:
Diaphyseal fractures of the humeral shaft
Fractures of the proximal humerus
Proximal humeral fractures with diaphyseal extension
Impending pathologic fractures
Malunions and nonunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033071: Synthes (Usa) Cannulated Titanium Humeral 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/K033071
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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