510(k) · Cleared
Recalled · Class II · 2019Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade Fem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 30, 2009 as substantially equivalent to K082770 (Zimmer, Inc., 2008) and 4 other predicates after a 117-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it. It has been recalled 16 times.
- Decided
- Jun 30, 2009
- Review
- 117 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 16
- Predicates
- 5
Its longest line of descent runs back 5 generations to K970097 (1997). 23 ancestors in all, the oldest K871539 (1987). 3 later devices descend from it, 1 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 deviceK090596 Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless…Zimmer, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK130595 Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- Descendant · 3 generations on · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
Most influential descendants
Showing 3 of 3 · See all- K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc. · 2013 · cites it directly2descendants
- K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018 · 2 generations on1descendant
- K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023 · 3 generations on0descendants
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) | K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis… | Zimmer, Inc. | 2009 | — |
| +1 | K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | Zimmer, Inc. | 2013 | 3 |
| +2 | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| +3 | K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K082770 | Zimmer Natural Nail System Tibial NailSummary page 1…21 CFR § 888.3020 Predicate Devices: Zimmer®Natural NailTM System Tibial Nail, manufactured by Zimmer, Inc. (K082770, cleared December 11, 2008) Zimmer Natural Nail System P… | 2008 |
| * | 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) Intramedullary Nail System,… | 2009 |
| * | K965098 | Intramedullary Nail SystemSummary page 1…February 19, 2009) Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997) Sirus®Nail System, manufactured by Zimmer,… | 1997 |
| * | K043270 | Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Summary page 1…mer, Inc. (K965098, cleared February 28, 1997) Sirus®Nail System, manufactured by Zimmer, GmbH. (K043270, cleared January 31, 2005) DePuy ACE Universal and Troch Entry Femoral… | 2005 |
| * | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsSummary page 1…DePuy ACE Universal and Troch Entry Femoral Nail Systems, manufactured by DePuy ACE. (K033329, cleared November 14, 2003) Device Description: The Zimmer Natural Nail System Stainless Steel… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0326-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Feb 9, 2011 | Not classified | Z-1835-2011 | Component change control | Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these components occurs, the following potential… |
| Jul 1, 2009 | Not classified | Z-0376-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0377-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0378-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0381-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0385-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0386-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0375-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0379-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0380-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0382-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0383-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0384-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0387-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
| Jul 1, 2009 | Not classified | Z-0388-2010 | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in… |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 23 ancestors have a recall of any class.
- Of its descendants, K130595 (Zimmer, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K082770.
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 the Tibial nails include the following in the tibia: * 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…
Read the full statement (150 words)
The Zimmer NaturalNail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for the Tibial nails include the following in the tibia:
* 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
Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur 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/K090596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090596: Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade Fem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090596
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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