510(k) · Cleared
Recalled · Class II · 2018Zimmer Natural Nail System Retrograde 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 Oct 1, 2010 as substantially equivalent to K962561 (Zimmer, Inc., 1996) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1997. 29 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 1, 2010
- Review
- 114 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K970097 (1997). 8 ancestors in all, the oldest K871539 (1987). 29 later devices descend from it, 6 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 deviceK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK172114 Zimmer Natural Nail SystemZimmer, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- Descendant · cites it directly · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
- Descendant · 2 generations on · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K172114Zimmer Natural Nail SystemZimmer, Inc. · 2017 · cites it directly11descendants
- K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · cites it directly10descendants
- K200869Gamma3 SystemStryker Trauma GmbH · 2020 · 2 generations on9descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · cites it directly7descendants
- K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · 2 generations on6descendants
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) | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | — |
| +1 | K172114 | Zimmer Natural Nail System | Zimmer, Inc. | 2017 | — |
| +1 | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | 7 |
| +2 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| +1 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
| +2 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K962561 | Supracondylar Intramedullary NailSummary page 1…ode HSB and Reference: 21 CFR § 888.3020 Predicate Devices: Supracondylar Intramedullary Nail, manufactured by Zimmer, Inc. (K962561, cleared September 25, 1996) DePuy ACE Universal and Troch Entry Femoral… | 1996 |
| * | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsSummary page 1…1996) DePuy ACE Universal and Troch Entry Femoral Nail Systems, manufactured by DePuy ACE (K033329, cleared November 14, 2003) Device Description: The Zimmer NaturalNail System Retrograde Femoral… | 2003 |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172114 | Zimmer Natural Nail System | 2017 | 11 |
| K142281 | Zimmer M/DN Intramedullary Fixation System | 2014 | 10 |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | 2021 | 7 |
| K171108 | AUTOBAHN Nailing System | 2017 | 2 |
| K253566 | Affixus Retrograde Femoral Nailing System | 2026 | 0 |
| K191238 | Zimmer Guide Wire Devices | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2018 | Class II | Z-1467-2018 | Under Investigation by firm | Potential failure of sterile packaging seal. |
| Mar 26, 2018 | Class II | Z-1469-2018 | Under Investigation by firm | Potential failure of sterile packaging seal. |
| Mar 26, 2018 | Class II | Z-1468-2018 | Under Investigation by firm | Potential failure of sterile packaging seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K172114 (Zimmer, Inc., 2017) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K962561.
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. 2010, 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 Zimmier Natural Nail System is intended for temporary fracture fixation and stabilization
of the bone.
Indications for use of the retrograde femoral nails in the femur include:
* Compound and simple shaft fractures
• Proximal, metaphyseal, and distal shaft fractures
* Segmental fractures
* Closed supracondylar fractures
* Severely comminuted supracondylar fractures with articular involvement
* Fractures involving femoral condyles
* Comminuted fractures
• Fractures involving osteopenic and osteoporotic bone
* Pathological fractures
* Fractures with bone loss
* Pseudoarthrosis, non-union, and mal-union
* Periprosthetic fractures
* Poly trauma patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101622: Zimmer Natural Nail System Retrograde 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/K101622
Report an extraction error
Are you the manufacturer?
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