510(k) · Cleared
ClearedPhantom Small Bone Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Jun 19, 2017 as substantially equivalent to K140397 (Paragon 28, 2014) after a 104-day review. Its family tree reaches back 13 generations to 1996. 9 later devices descend from it.
- Decided
- Jun 19, 2017
- Review
- 104 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954385 (1996). 183 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
- Descendant · cites it directly · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
Show all 13 generations
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 11 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 10 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 9 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 8 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 7 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 6 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 5 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 4 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · cites it directly8descendants
- K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 2 generations on6descendants
- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 3 generations on5descendants
- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −12 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −11 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −10 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −9 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −8 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −7 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −6 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −5 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −4 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −3 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| 0 (this device) | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
| +1 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| +2 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | — |
| +2 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +3 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +4 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 17 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 15 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K140397 | Paralock Plating System / Tuffnek ScrewSummary page 4…m implants are manufactured from medical grade titanium alloy (per ASTM F136). Primary Predicate: ParaLock Plating System™ (Paragon 28, Inc. – K140397) Performance Data: Mechanical testing of the worst case Phantom™ nail included static and dynamic ben… | 2014 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | 2019 | 8 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 43 of the 183 ancestors have a recall of any class.
- Of its descendants, K182307 (Paragon 28, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K140397.
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Phantom™ Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170693: Phantom Small Bone Intramedullary 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/K170693
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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