510(k) · Cleared
Recalled · Class II · 2018Zimmer Natural Nail System Tibial Nail
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 Dec 11, 2008 as substantially equivalent to K965098 (Zimmer, Inc., 1997) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1992. 35 later devices descend from it. It has been recalled 15 times.
- Decided
- Dec 11, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 15
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914453 (1992). 14 ancestors in all. 35 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK914453 Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa) · 1992
- 2 generations backK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001
- 1 generation backK032097 Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003
- This deviceK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008
- Descendant · cites it directly · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- Descendant · 2 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 · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 3 generations on · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · 3 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · cites it directly16descendants
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 2 generations on15descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · 3 generations on9descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914453 | Universal Tibial Nail and Unreamed Tibial Nail | Synthes (Usa) | 1992 | — |
| −2 | K013430 | Ace Bio Win Tibial Nailing System | DePuy Orthopaedics, Inc. | 2001 | — |
| −1 | K032097 | Depuy Ace Versanail Tibial Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K082770 | Zimmer Natural Nail System Tibial Nail | Zimmer, Inc. | 2008 | — |
| +1 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| +2 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +3 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +3 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 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 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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, hic. (K965098, cleared February 28, 1997) Siruso Intramedullary Nail, manufactured by… | 1997 |
| * | K043270 | Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Summary page 1…. (K965098, cleared February 28, 1997) Siruso Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, cleared January 31, 2005) DePuy Ace Versa Nail Tibial N… | 2005 |
| * | K032097 | Depuy Ace Versanail Tibial NailSummary page 1…2005) DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003) Device Description: The Zimmer Natural Nail System… | 2003 |
What descends from it? (35)
See all 358 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws… | 2018 | 16 |
| K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail | 2014 | 10 |
| 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 |
| K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | 2013 | 2 |
| K170972 | Apex Tibial Nailing System | 2017 | 1 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | 2026 | 0 |
| K243907 | Affixus Tibial Nailing System - 4mm screws | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2018 | Class II | Z-3246-2018 | Mixed-up of materials/components | The item is labeled as an 8.3mm, but it is actually a 12 mm. |
| 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 15 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 16 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K180436 (Stryker Trauma GmbH, 2018) has gone furthest, with 16 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. 2008, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K082770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082770: Zimmer Natural Nail System Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082770
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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