510(k) · Cleared
ClearedPhantom Metatarsal Shortening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 16, 2022 as substantially equivalent to K203011 (Paragon 28, Inc., 2020) and 1 other predicate after a 65-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Dec 16, 2022
- Review
- 65 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K962616 (1996). 134 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK223184 Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 5 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 4 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK223184 Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −5 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −4 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −3 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| −1 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
| 0 (this device) | K223184 | Phantom Metatarsal Shortening System | Paragon 28, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K203011 | Monster Screw SystemSummary page 5…nts are designed to provide stability and fixation of bone fragments to ultimately achieve fusion. Primary Predicate Monster Screw System (K203011) Device: Additional Predicate: HammerTube System (K171715) Reference Devices: ITS HOL Plate (K131722)… | 2020 |
| * | K171715 | HammerTube SystemSummary page 5…bone fragments to ultimately achieve fusion. Primary Predicate Monster Screw System (K203011) Device: Additional Predicate: HammerTube System (K171715) Reference Devices: ITS HOL Plate (K131722) Phantom Small Bone Intramedullary Nail System (K182307)… | 2018 |
| † | K131722 | I.T.S. Extremity Fixation Systems | 2013 |
| † | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | 2019 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 29 of the 134 ancestors have a recall of any class.
- 5 other devices also cite its predicate K203011.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Phantom Metatarsal Shortening System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Metatarsal and phalangeal osteotomies
Metatarsal deformity correction
Hammertoe
Revision hammertoe
Claw toe
Mallet toe
Proximal Interphalangeal Joint Arthrodesis
Distal Interphalangeal Joint Arthrodesis
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/K223184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223184: Phantom Metatarsal Shortening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223184
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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