510(k) · Cleared
ClearedPhantom® Hindfoot TTC/TC 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 Mar 5, 2026 as substantially equivalent to K251850 (Paragon 28, Inc., 2025) after a 108-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Mar 5, 2026
- Review
- 108 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K954385 (1996). 294 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- 2 generations backK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- 1 generation backK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
- This deviceK253591 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 17 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 16 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 15 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 14 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 13 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 12 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 11 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 10 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 9 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 8 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 5 generations backK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
- 4 generations backK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- 3 generations backK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- 2 generations backK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- 1 generation backK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
- This deviceK253591 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −17 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −16 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −15 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −14 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −13 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −12 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −11 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −10 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −9 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −8 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −5 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
| −4 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| −3 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| −2 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| −1 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | — |
| 0 (this device) | K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 15 | 0 |
| 1997 | 7 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 19 | 0 |
| 2001 | 28 | 0 |
| 2002 | 25 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 21 | 0 |
| 2006 | 15 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 11 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K251850 | Phantom® Hindfoot TTC/TC Nail SystemSummary page 5…repared: March 04, 2026 Device Trade Phantom® Hindfoot TTC/TC Nail System Names: Device Class: Class II Primary Phantom® Hindfoot TTC/TC Nail System (K251850) Predicate(s): Device Description: Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nail… | 2025 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 74 of the 294 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. 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 Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: • Post-traumatic or degenerative arthritis • Previously infected arthrosis • Revision of failed ankle arthrodesis • Revision of failed total ankle arthroplasty • Talar deficiency…
Read the full statement (134 words)
The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
• Post-traumatic or degenerative arthritis
• Previously infected arthrosis
• Revision of failed ankle arthrodesis
• Revision of failed total ankle arthroplasty
• Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• Trauma (severe or malunited tibial pilon fracture)
• Charcot foot (neuroarthropathy)
• Severe end-stage degenerative arthritis
• Instability and skeletal defects after tumor resection
• Pantalar arthrodesis
• Severe foot/ankle deformity
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/K253591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253591: Phantom® Hindfoot TTC/TC Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253591
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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