510(k) · Cleared
ClearedZimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Switzerland Manufacturing GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 9, 2023 as substantially equivalent to K091566 (Zimmer GmbH, 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 7 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 9, 2023
- Review
- 112 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K970097 (1997). 29 ancestors in all, the oldest K871539 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 5 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 4 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 3 generations backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- 2 generations backK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
- 1 generation backK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- This deviceK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · cites it directly · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK243907 Affixus Tibial Nailing System - 4mm screwsZimmer, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · cites it directly2descendants
- K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026 · 2 generations on0descendants
- K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH · 2025 · cites it directly0descendants
- K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −6 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −5 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −4 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −3 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| −2 | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | 7 |
| −1 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| 0 (this device) | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +1 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
| +2 | K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026 | — |
| +1 | K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | 2025 | — |
| +2 | K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K091566 | Zimmer Natural Nail System Cephalomedullary NailsSummary page 5…ary Fixation Rod Predicate Device: Zimmer® Natural Nail™ System Cephalomedullary Nails, manufactured by Zimmer GmbH, K091566, cleared on October 28, 2009 Affixus® Natural Nail® System… | 2009 |
| * | K181827 | Affixus Natural Nail System Humeral NailSummary page 5…2009 Affixus® Natural Nail® System Humeral Nail, manufactured by Zimmer GmbH, K181827, cleared on December 14, 2018 The Zimmer Natural Nail System Cephalomedullary Nails are Device… | 2018 |
What descends from it? (4)
2 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 26 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 16 of the 29 ancestors have a recall of any class.
- Of its descendants, K241651 (Zimmer, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K091566.
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. 2023, 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 Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include: * Compound and simple shaft fractures. * Proximal, metaphyseal and distal shaft fractures. * Segmental fractures. * Comminuted fractures. * Fractures involving osteopenic and…
Read the full statement (167 words)
The Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include:
* Compound and simple shaft fractures.
* Proximal, metaphyseal and distal shaft fractures.
* Segmental fractures.
* Comminuted fractures.
* Fractures involving osteopenic and osteoporotic bone.
* Pathological fractures.
* Fractures with bone loss
* Pseudoarthrosis, non-union, mal-union and delayed union.
* Periprosthetic fractures.
* Surgically created defects such as osteotomies.
* Intertrochanteric and subtrochanteric fractures.
The Affixus Natural Nail Humeral Nail System nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.
The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:
* Proximal fractures (proximal short and long nails only).
* Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only).
* Open and closed fractures.
* Comminuted fractures.
* Nonunions and malunions.
* Pathologic fractures.
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/K231114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231114
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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