510(k) · Cleared
ClearedMonster Screw 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 Nov 13, 2020 as substantially equivalent to K190586 (Paragon 28, Inc., 2019) after a 43-day review. Its family tree reaches back 14 generations to 1996. 6 later devices descend from it.
- Decided
- Nov 13, 2020
- Review
- 43 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962616 (1996). 127 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 6 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 2 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 1 generation backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- This deviceK203011 Monster Screw SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK251555 Ultra™ Compression Screw SystemPace Surgical · 2025
- Descendant · cites it directly · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK261647 Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026
- Descendant · cites it directly · 0 of its ownK241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223184 Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 3 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 2 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 1 generation backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- This deviceK203011 Monster Screw SystemParagon 28, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K251555Ultra™ Compression Screw SystemPace Surgical · 2025 · cites it directly1descendant
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · cites it directly1descendant
- K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical · 2026 · cites it directly0descendants
- K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024 · cites it directly0descendants
- K223184Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −3 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −2 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −1 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
| +1 | K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025 | — |
| +1 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +1 | K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026 | — |
| +1 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | — |
| +1 | 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 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 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 K243943 TriMed® Compression Screwsscore 18.4 · 12 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 |
|---|---|---|---|
| * | K190586 | Monster® Screw SystemSummary page 5…or threaded bone fixation fastener Class: II Product Code: HWC Predicate Device: Monster Screw System (K190586) Reference Devices: Hammertoe Compression System (K183228) JAWS Nitinol Staple… | 2019 |
| † | K183228 | HammerToe Compression System | 2019 |
| † | K170923 | JAWS (TM) Nitinol Staple System | 2017 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251555 | Ultra™ Compression Screw System | 2025 | 1 |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation… | 2023 | 1 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | 2026 | 0 |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | 2024 | 0 |
| K223184 | Phantom Metatarsal Shortening System | 2022 | 0 |
| K221342 | REDEMPTION Beaming System | 2022 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 127 ancestors have a recall of any class.
- Of its descendants, K251555 (Pace Surgical, 2025) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K190586.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies * Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) * Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) * Talar fractures * Ankle…
Read the full statement (181 words)
The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Fractures and Osteotomies
* Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
* Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
* Talar fractures
* Ankle fractures
* Navicular fractures
* Fractures of the fibula, malleolus, and calcaneus
* Metatarsal and phalangeal osteotomies
* Weil osteotomy
* Calcaneal osteotomy
Hallux Valgus Correction
* Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
* Interphalangeal (IP) arthrodesis
* Proximal, midshaft, or distal osteotomy
* Lapidus arthrodesis
Arthrodesis/Deformity Correction
* 1st MTP arthrodesis
* Metatarsal deformity correction
* Tarsometatarsal joint arthrodesis
* Naviculocuneiform joint arthrodesis
* Talonavicular arthrodesis
* Subtalar joint arthrodesis
* Triple arthrodesis
* Medial column arthrodesis
* Subtalar joint distraction arthrodesis
* Ankle arthrodesis
* Lateralizing calcaneal osteotomy
* Lateral column lengthening
* Hammertoe
Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:
* Medial and lateral column
* Subtalar, talonavicular, and calcaneocuboid
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/K203011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203011: Monster Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203011
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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