510(k) · Cleared
Recalled · Class II · 2021Zimmer Natural Nail System Cephalomedullary Nails
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 Oct 28, 2009 as substantially equivalent to K083497 (Zimmer, Inc., 2009) and 2 other predicates after a 153-day review. Its family tree reaches back 5 generations to 1997. 16 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 28, 2009
- Review
- 153 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 5 generations to K970097 (1997). 18 ancestors in all, the oldest K871539 (1987). 16 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 2 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 1 generation backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- This deviceK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009
- Descendant · cites it directly · 10 of its ownK120715 Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012
- Descendant · cites it directly · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · cites it directly · 4 of its ownK192312 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2019
- Descendant · 2 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012 · cites it directly10descendants
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · cites it directly4descendants
- K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2019 · cites it directly4descendants
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 2 generations on3descendants
- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −3 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −2 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −1 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| 0 (this device) | K091566 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2009 | — |
| +1 | K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short | Zimmer GmbH | 2012 | — |
| +1 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +1 | K192312 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2019 | — |
| +2 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
| +1 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsSummary page 1…stem Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails, manufactured by Zimmer, Inc. (K083497, cleared February 19, 2009) I. T S. T TM Intertrochanter… | 2009 |
| * | K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailSummary page 1…T TM Intertrochanteric Subtrochanteric Intramedullary Femoral Nail, manufactured by Zimmer, Inc. (K032367, cleared August 12, 2003) Intramedullary Nail System, manufactured by… | 2003 |
| * | K965098 | Intramedullary Nail SystemSummary page 1…nc. (K032367, cleared August 12, 2003) Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997) Device Description: The Zimmer NaturalNail System… | 1997 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short | 2012 | 10 |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail… | 2023 | 4 |
| K192312 | Zimmer Natural Nail System Cephalomedullary Nails | 2019 | 4 |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | 2024 | 2 |
| K140601 | Flow-Nail | 2014 | 2 |
| K181640 | X-BOLT Hip Fracture Fixation System | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2021 | Class II | Z-1792-2021 | Process design | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree |
| May 7, 2021 | Class II | Z-1793-2021 | Process design | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree |
| Oct 10, 2019 | Class II | Z-0337-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Sep 3, 2015 | Class II | Z-0119-2016 | Package design/selection | In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or… |
| Oct 29, 2010 | Not classified | Z-0824-2011 | Nonconforming Material/Component | The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 18 ancestors have a recall of any class.
- Of its descendants, K120715 (Zimmer GmbH, 2012) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K083497.
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. 2009, 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 NaturalNail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the Cephalomedullary nails 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091566 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091566: Zimmer Natural Nail System Cephalomedullary Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091566
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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