510(k) · Cleared
Recalled · Class II · 2025Phantom Fibula Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 22, 2024 as substantially equivalent to K163014 (Advanced Orthopaedic Solutions, Inc. (Aos), 2017) and 1 other predicate after a 238-day review. Its family tree reaches back 6 generations to 1996. It has been recalled once.
- Decided
- Aug 22, 2024
- Review
- 238 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K960642 (1996). 18 ancestors in all, the oldest K913949 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK960642 Nancy NailLandos, Inc. · 1996
- 5 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 4 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 3 generations backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- 2 generations backK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
- 1 generation backK163014 AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
- This deviceK234128 Phantom Fibula Nail SystemParagon 28, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −5 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −4 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −3 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| −2 | K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 | — |
| −1 | K163014 | AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017 | — |
| 0 (this device) | K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K163014 | AOS Small Bone Nailing SystemSummary page 4…e intended use of fibula repair. The implants are provided in multiple sizes and lengths. Primary Predicate: AOS Small Bone Nailing System (K163014) Additional Predicate: Arthrex FibuLock Nail (K173656) Reference Device: Acumed Small Bone IM Nail System (K143276)… | 2017 |
| * | K173656 | Arthrex FibuLock NailSummary page 4…are provided in multiple sizes and lengths. Primary Predicate: AOS Small Bone Nailing System (K163014) Additional Predicate: Arthrex FibuLock Nail (K173656) Reference Device: Acumed Small Bone IM Nail System (K143276)… | 2018 |
| † | K143276 | Acumed Small Bone IM Nail System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2025 | Class II | Z-0871-2026 | Device Design | Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 18 ancestors have a recall of any class.
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 Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.
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/K234128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234128: Phantom Fibula Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234128
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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