510(k) · Cleared
ClearedZimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short
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 Aug 10, 2012 as substantially equivalent to K091566 (Zimmer GmbH, 2009) and 1 other predicate after a 155-day review. Its family tree reaches back 6 generations to 1997. 10 later devices descend from it.
- Decided
- Aug 10, 2012
- Review
- 155 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970097 (1997). 19 ancestors in all, the oldest K871539 (1987). 10 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 backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 1 generation backK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled
- This deviceK120715 Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012
- 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 ownK140601 Flow-NailFlow-Fx, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK221115 Flow-NailFlow-Fx, LLC · 2022
- Descendant · cites it directly · 1 of its ownK181640 X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K140601Flow-NailFlow-Fx, LLC · 2014 · cites it directly2descendants
- K221115Flow-NailFlow-Fx, LLC · 2022 · 2 generations on1descendant
- K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018 · cites it directly1descendant
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 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −1 | K091566 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2009 | 5 |
| 0 (this device) | K120715 | Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short | Zimmer GmbH | 2012 | — |
| +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 | K140601 | Flow-Nail | Flow-Fx, LLC | 2014 | — |
| +2 | K221115 | Flow-Nail | Flow-Fx, LLC | 2022 | — |
| +1 | K181640 | X-BOLT Hip Fracture Fixation System | X-Bolt Orthopaedics | 2018 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 1…nd References: section 888.3020) Predicate Devices: Zimmer Natural Nail System Cephalomedullary Femoral Nails, Manufactured by Zimmer, K091566, cleared October 28, 2009 and Intramedullary Nail System, Manufactured by Zimmer, K… | 2009 |
| * | K965098 | Intramedullary Nail SystemSummary page 1…Nails, Manufactured by Zimmer, K091566, cleared October 28, 2009 and Intramedullary Nail System, Manufactured by Zimmer, K965098, cleared February 28, 1997. Device Description: The Zimmer Natural Nail System Cephalomedullary… | 1997 |
What descends from it? (10)
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 15 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 12 of the 19 ancestors have a recall of any class.
- Of its descendants, K192312 (Zimmer GmbH, 2019) has gone furthest, with 4 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. 2012, 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 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/K120715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120715
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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