510(k) · Cleared
Recalled · Class II · 2025Affixus Tibial and Antegrade 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 Sep 26, 2024 as substantially equivalent to K082770 (Zimmer, Inc., 2008) and 5 other predicates after a 111-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it. It has been recalled 17 times.
- Decided
- Sep 26, 2024
- Review
- 111 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 17
- Predicates
- 6
Its longest line of descent runs back 8 generations to K970097 (1997). 41 ancestors in all, the oldest K871539 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 6 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 5 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 4 generations backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
- 3 generations backK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
- 2 generations backK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- 1 generation backK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- This deviceK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253566 Affixus Retrograde Femoral Nailing SystemZimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243907 Affixus Tibial Nailing System - 4mm screwsZimmer, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −8 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −7 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −6 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −5 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −4 | K101622 | Zimmer Natural Nail System Retrograde Femoral Nails | Zimmer, Inc. | 2010 | 3 |
| −3 | K142281 | Zimmer M/DN Intramedullary Fixation System | Zimmer, Inc. | 2014 | 7 |
| −2 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| −1 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| 0 (this device) | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | — |
| +1 | K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026 | — |
| +1 | K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (6)
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 5…3020 Product Code(s) HSB, HWC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K082770 Zimmer Natural Nail System — Tibial Nail HSB K063570 Biomet Tibial Locking Nail System HSB K083497 ZIMMER NATURAL NAIL SYSTEM PIR… | 2008 |
| * | K063570 | Biomet Tibial Locking Nail SystemSummary page 5…dicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K082770 Zimmer Natural Nail System — Tibial Nail HSB K063570 Biomet Tibial Locking Nail System HSB K083497 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDg| | HSB K072161 Biomet Femoral Lock… | 2007 |
| * | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsSummary page 5…Predicate Trade Name (Primary Predicate is listed first) Product Code K082770 Zimmer Natural Nail System — Tibial Nail HSB K063570 Biomet Tibial Locking Nail System HSB K083497 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDg| | HSB K072161 Biomet Femoral Locking Nailing System HSB K091566 Zimmer® Natural… | 2009 |
| * | K072161 | Biomet Femoral Locking Nail SystemSummary page 5…t Code K082770 Zimmer Natural Nail System — Tibial Nail HSB K063570 Biomet Tibial Locking Nail System HSB K083497 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDg| | HSB K072161 Biomet Femoral Locking Nailing System HSB K091566 Zimmer® Natural Nail® System Cephalomedullary Nails HSB K231114 Zimmer® Natural… | 2007 |
| * | K091566 | Zimmer Natural Nail System Cephalomedullary NailsSummary page 5…Nail HSB K063570 Biomet Tibial Locking Nail System HSB K083497 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDg| | HSB K072161 Biomet Femoral Locking Nailing System HSB K091566 Zimmer® Natural Nail® System Cephalomedullary Nails HSB K231114 Zimmer® Natural Nail® System Cephalomedullary Nails HSB I Device… | 2009 |
| * | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Summary page 5…ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDg| | HSB K072161 Biomet Femoral Locking Nailing System HSB K091566 Zimmer® Natural Nail® System Cephalomedullary Nails HSB K231114 Zimmer® Natural Nail® System Cephalomedullary Nails HSB I Device Description Summary 21 CFR 807.92(a)(4) K241651… | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2025 | Class II | Z-0976-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0970-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0971-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0973-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0975-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0967-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0968-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0969-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0972-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0978-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0979-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0983-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0974-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0977-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0980-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0981-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
| Dec 2, 2025 | Class II | Z-0982-2026 | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache… |
The 5 latest of 17 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 27 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 22 of the 41 ancestors have a recall of any class.
- Of its descendants, K253566 (Zimmer, Inc., 2026) has gone furthest, with 0 descendants 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. 2024, 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® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.
The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.
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/K241651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241651: Affixus Tibial and Antegrade Femoral Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241651
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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