510(k) · Cleared
Recalled · Class II · 2013Zimmer Natural Nail System Tibial Nail and Stainless Steel 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 Sep 17, 2013 as substantially equivalent to K082770 (Zimmer, Inc., 2008) and 1 other predicate after a 194-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 17, 2013
- Review
- 194 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970097 (1997). 24 ancestors in all, the oldest K871539 (1987). 2 later devices descend from it, 1 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 backK090596 Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless…Zimmer, Inc. · 2009 · Recalled
- This deviceK130595 Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- Descendant · 2 generations on · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
Most influential descendants
Showing 2 of 2 · See allView 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 | K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis… | Zimmer, Inc. | 2009 | 16 |
| 0 (this device) | K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | Zimmer, Inc. | 2013 | — |
| +1 | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K082770 | Zimmer Natural Nail System Tibial NailSummary page 1…(21 CFR 888.3020, Product Code HSB) Classification Panel: Orthopedics/87 Predicate Devices: Zimmer Natural Nail (ZNN) System Tibia[ Nail (K082770, cleared December 11. 2008). Zimmer Natural Nlail System Stainless Steel… | 2008 |
| * | K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Summary page 1…stem Tibia[ Nail (K082770, cleared December 11. 2008). Zimmer Natural Nlail System Stainless Steel Tibial Nail (K090596, cleared June 30, 2009) Purpose: This Special 5 10(k) is being submitted to add eight instruments to… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181184 | OIC Intramedullary Nail System | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2013 | Class II | Z-0586-2014 | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements… |
| Nov 5, 2013 | Class II | Z-0590-2014 | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements… |
| Nov 5, 2013 | Class II | Z-0592-2014 | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 13 of the 24 ancestors have a recall of any class.
- Of its descendants, K181184 (The Orthopaedic Implant Company, 2018) has gone furthest, with 1 descendant 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. 2013, 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…
Read the full statement (100 words)
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
When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130595: Zimmer Natural Nail System Tibial Nail and Stainless Steel 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/K130595
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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