510(k) · Cleared
Recalled · Class II · 2017Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
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 Feb 19, 2009 as substantially equivalent to K965098 (Zimmer, Inc., 1997) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1997. 39 later devices descend from it. It has been recalled 16 times.
- Decided
- Feb 19, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 16
- Predicates
- 3
Its longest line of descent runs back 4 generations to K970097 (1997). 16 ancestors in all, the oldest K871539 (1987). 39 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 3 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 2 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 1 generation backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- This deviceK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · cites it directly · 16 of its ownK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled
- Descendant · 3 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- Descendant · cites it directly · 11 of its ownK172114 Zimmer Natural Nail SystemZimmer, Inc. · 2017
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · cites it directly17descendants
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
- K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · cites it directly16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 3 generations on15descendants
- K172114Zimmer Natural Nail SystemZimmer, Inc. · 2017 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −3 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −2 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −1 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| 0 (this device) | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | — |
| +1 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| +2 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +1 | K091566 | Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH | 2009 | 5 |
| +3 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| +1 | K172114 | Zimmer Natural Nail System | Zimmer, Inc. | 2017 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K965098 | Intramedullary Nail SystemSummary page 1…21 CFR § 888.3020 Predicate Devices: 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 Orthopaedics (K033329, cleared November 14, 2003) Device Description: The Zimmer NaturalNail Syste… | 2003 |
What descends from it? (39)
See all 397 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | 2018 | 17 |
| K091566 | Zimmer Natural Nail System Cephalomedullary Nails | 2009 | 16 |
| K172114 | Zimmer Natural Nail System | 2017 | 11 |
| K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and… | 2009 | 3 |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | 2024 | 2 |
| K171108 | AUTOBAHN Nailing System | 2017 | 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 |
|---|---|---|---|---|
| Apr 28, 2017 | Class II | Z-2599-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Jun 17, 2015 | Class II | Z-2060-2015 | Process control | A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure… |
| 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 4.1 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K172774 (Stryker Trauma GmbH, 2018) has gone furthest, with 17 descendants of its own.
- 8 other devices also cite its predicate K965098.
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 Greater Trochanter and Piriformis Fossa 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/K083497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083497
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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