510(k) · Cleared
ClearedAffixus Retrograde Femoral Nailing System
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 Mar 12, 2026 as substantially equivalent to K072161 (Biomet Manufacturing Corp, 2007) and 2 other predicates after a 115-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Mar 12, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K970097 (1997). 42 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations between
- 3 generations backK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- 2 generations backK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- 1 generation backK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- This deviceK253566 Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 8 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 7 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 6 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 5 generations backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- 4 generations backK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
- 3 generations backK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- 2 generations backK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- 1 generation backK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- This deviceK253566 Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −8 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −7 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −6 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −5 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| −4 | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | 7 |
| −3 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| −2 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| −1 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
| 0 (this device) | K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K072161 | Biomet Femoral Locking Nail SystemSummary page 5…888.3020 Product Code(s) HSB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K072161 Biomet Femoral Locking Nail System HSB K101622 Zimmer Natural Nail System Retrograde Femoral Nails HSB K241651 Affixus Tibial and… | 2007 |
| * | K101622 | Zimmer Natural Nail System Retrograde Femoral NailsSummary page 5…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K072161 Biomet Femoral Locking Nail System HSB K101622 Zimmer Natural Nail System Retrograde Femoral Nails HSB K241651 Affixus Tibial and Antegrade Femoral Nailing System HSB Device De… | 2010 |
| * | K241651 | Affixus Tibial and Antegrade Femoral Nailing SystemSummary page 5…rade Name (Primary Predicate is listed first) Product Code K072161 Biomet Femoral Locking Nail System HSB K101622 Zimmer Natural Nail System Retrograde Femoral Nails HSB K241651 Affixus Tibial and Antegrade Femoral Nailing System HSB Device Description Summary 21 CFR 807.92(a)(4) The Affixus Retrograde Fe… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 23 of the 42 ancestors have a recall of any class.
- 4 other devices also cite its predicate K072161.
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. 2026, 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 Affixus Retrograde Femoral Nailing System is indicated for:
• 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253566 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253566: Affixus Retrograde Femoral Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253566
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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