510(k) · Cleared
ClearedAffixus Natural Nail System Humeral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 14, 2018 as substantially equivalent to K033878 (Depuy Ace, 2004) and 3 other predicates after a 158-day review. Its family tree reaches back 6 generations to 1997. 6 later devices descend from it.
- Decided
- Dec 14, 2018
- Review
- 158 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K970097 (1997). 18 ancestors in all, the oldest K871539 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 4 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 3 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 2 generations backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- 1 generation backK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
- This deviceK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- Descendant · cites it directly · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · 2 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- Descendant · cites it directly · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK253566 Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253749 Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · cites it directly4descendants
- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 2 generations on2descendants
- K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · cites it directly1descendant
- K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026 · 3 generations on0descendants
- K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −5 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −4 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −3 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −2 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| −1 | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | 7 |
| 0 (this device) | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| +1 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +2 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
| +1 | K200814 | Affixus (R) Natural Nail (R) System Humeral Nail | Zimmer GmbH | 2020 | — |
| +3 | K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026 | — |
| +1 | K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K033878 | Ace Antegrade Retrograde Humeral Nail SystemSummary page 4…21 CFR § 888.3020 number – Intramedullary fixation rod Description: Predicate Device: Versanail® Nailing System, manufactured by Biomet Trauma Inc, K033878 (Ace® Antegrade Retrograde Humeral Nail System, primary predicate) and… | 2004 |
| * | K033806 | Ace Proximal Humeral Nail SystemSummary page 4…ured by Biomet Trauma Inc, K033878 (Ace® Antegrade Retrograde Humeral Nail System, primary predicate) and K033806 (Ace® Proximal Humeral Nail System) both cleared in 20 February 2004 and M/DN® Intramedullary Fix… | 2004 |
| * | K142281 | Zimmer M/DN Intramedullary Fixation SystemSummary page 4…m) both cleared in 20 February 2004 and M/DN® Intramedullary Fixation System, manufactured by Zimmer Inc, K142281 cleared 22 October 2014, K965098 cleared in 28 February 1997. Device Description: The Affixus Natural Nail System Hum… | 2014 |
| * | K965098 | Intramedullary Nail SystemSummary page 4…2004 and M/DN® Intramedullary Fixation System, manufactured by Zimmer Inc, K142281 cleared 22 October 2014, K965098 cleared in 28 February 1997. Device Description: The Affixus Natural Nail System Humeral nails are temporary fixation… | 1997 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 10 of the 18 ancestors have a recall of any class.
- Of its descendants, K231114 (Zimmer Switzerland Manufacturing GmbH, 2023) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K033878.
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. 2018, 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 AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is…
Read the full statement (130 words)
The AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.
The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:
• Proximal fractures (proximal short and long nails only)
• Diaphyseal fractures (proximal long, antegrade/retrograde nails)
• Open and closed fractures
• Comminuted fractures
• Nonunions and malunions
• Pathologic fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181827: Affixus Natural Nail System Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181827
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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