510(k) Report

510(k) · Cleared

Cleared

Monster® Screw System

K190586510(k) SpecialCleared Apr 3, 201928-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Paragon 28, Inc. · HWC Screw, Fixation, Bone

Cleared on Apr 3, 2019 as substantially equivalent to K124027 (Apogee Orthosolutions, 2013) and 7 other predicates after a 28-day review. Its family tree reaches back 13 generations to 1996. 21 later devices descend from it.

Decided
Apr 3, 2019
Review
28 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
8

Its longest line of descent runs back 13 generations to K962616 (1996). 126 ancestors in all, the oldest K792022 (1979). 21 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 2 other ancestors2014: 2 other ancestors2013: 1 other ancestor2010: 3 other ancestors2012: 1 other ancestor2011: 2 other ancestors2009: 3 other ancestors2008: 6 other ancestors2007: 3 other ancestors2006: 10 other ancestors2005: 6 other ancestors2002: 6 other ancestors2001: 8 other ancestors1999: 6 other ancestors1998: 5 other ancestors1997: 1 other ancestor1996: 11 other ancestors1993: 2 other ancestors2003: 2 other ancestors2000: 7 other ancestors1995: 6 other ancestors1990: 1 other ancestor1994: 4 other ancestors1992: 2 other ancestors1989: 4 other ancestors1987: 1 other ancestor1981: 1 other ancestor1979: 2 other ancestors2004: 4 other ancestors1991: 1 other ancestor2020: 3 descendants cleared2022: 3 descendants cleared2021: 1 descendant cleared2023: 6 descendants cleared2024: 2 descendants cleared2025: 2 descendants cleared2026: 4 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K124027 · Monster Screw System · Apogee Orthosolutions · 2013×2: 2 generations cleared close together, K151418 (2015), K153378 (2015) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 27 other ancestors3 generations back: 35 other ancestors4 generations back: 29 other ancestors5 generations back: 10 other ancestors6 generations back: 5 other ancestors9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K153378 · Monster BITE Screw System · Paragon 28 · 2015K151418 · Monster Screw System · Paragon 28 · 2015K124027 · Monster Screw System · Apogee Orthosolutions · 2013K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations between
  3. 3 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
  4. 2 generations backK151418 Monster Screw SystemParagon 28 · 2015
  5. 1 generation backK153378 Monster BITE Screw SystemParagon 28 · 2015
  6. This deviceK190586 Monster® Screw SystemParagon 28, Inc. · 2019
  7. Descendant · cites it directly · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  8. Descendant · 2 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
  9. Descendant · cites it directly · 6 of its ownK203011 Monster Screw SystemParagon 28, Inc. · 2020
  10. Descendant · 2 generations on · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
  11. Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
Show all 13 generations
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 4 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. 3 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
  12. 2 generations backK151418 Monster Screw SystemParagon 28 · 2015
  13. 1 generation backK153378 Monster BITE Screw SystemParagon 28 · 2015
  14. This deviceK190586 Monster® Screw SystemParagon 28, Inc. · 2019

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2020: 32021: 12022: 32023: 62024: 22025: 22026: 4
2020high 6 (2023) · low 1 (2021)2026

Most influential descendants

Showing 5 of 21 · See all
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · cites it directly9descendants
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 2 generations on8descendants
  • K203011Monster Screw SystemParagon 28, Inc. · 2020 · cites it directly6descendants
  • K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · 2 generations on4descendants
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−12K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−11K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−10K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−7K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−6K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−5K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
−3K124027Monster Screw SystemApogee Orthosolutions2013—
−2K151418Monster Screw SystemParagon 282015—
−1K153378Monster BITE Screw SystemParagon 282015—
0 (this device)K190586Monster® Screw SystemParagon 28, Inc.2019—
+1K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—
+1K203011Monster Screw SystemParagon 28, Inc.2020—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia…Stryker GmbH2023—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198110
198710
198940
199010
199110
199220
199320
199440
199560
1996110
199710
199850
199960
200070
200180
200260
200320
200440
200560
2006100
200730
200860
200930
201030
201120
201210
201310
201420
201720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202030
202110
202230
202360
202420
202520
202640
FIG. 1 — Lineage of K190586, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K124027Monster Screw System
Summary page 5
…Class: II Product Code: HWC; Screw, fixation, bone Primary Predicate Device: Paragon 28 Monster Screw System (K124027, K151418, K153378) Additional Predicates: Wright MICA Screw (K162353) Extremi…
Apogee Orthosolutions2013—
*K151418Monster Screw System
Summary page 5
…s: II Product Code: HWC; Screw, fixation, bone Primary Predicate Device: Paragon 28 Monster Screw System (K124027, K151418, K153378) Additional Predicates: Wright MICA Screw (K162353) Extremity Medica…
Paragon 282015—
*K153378Monster BITE Screw System
Summary page 5
…II Product Code: HWC; Screw, fixation, bone Primary Predicate Device: Paragon 28 Monster Screw System (K124027, K151418, K153378) Additional Predicates: Wright MICA Screw (K162353) Extremity Medical Axis Ch…
Paragon 282015—
*K162353MICATM Screw System
Summary page 5
…rew, fixation, bone Primary Predicate Device: Paragon 28 Monster Screw System (K124027, K151418, K153378) Additional Predicates: Wright MICA Screw (K162353) Extremity Medical Axis Charcot Fixation System (K171018)…
Wrightmedicaltechnologyinc2017—
*K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
Summary page 5
…K151418, K153378) Additional Predicates: Wright MICA Screw (K162353) Extremity Medical Axis Charcot Fixation System (K171018) Biomet Headless Compression and Twist-Off Screws (K142658)…
Extremity Medical, LLC2017—
*K142658Biomet Headless Compression and Twist-off Screws
Summary page 5
…Extremity Medical Axis Charcot Fixation System (K171018) Biomet Headless Compression and Twist-Off Screws (K142658) Extremity Medical Screw and Washer System (K101700) Ac…
Biomet Manufacturing Corp20142
*K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw System
Summary page 5
…Biomet Headless Compression and Twist-Off Screws (K142658) Extremity Medical Screw and Washer System (K101700) Acumed Cannulated Screw System (K123890) Indications for Use: The Monster® Scr…
Extremity Medical, LLC20102
*K123890Acumed Cannulated Screw System
Summary page 5
…s (K142658) Extremity Medical Screw and Washer System (K101700) Acumed Cannulated Screw System (K123890) Indications for Use: The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis,…
Acumed, LLC20132

Also cleared against K124027: 5 other devices →

What descends from it? (21)

See all 21

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209
K203011Monster Screw SystemParagon 28, Inc.20206
K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201
K221342REDEMPTION Beaming SystemVilex, LLC20220
K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210

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 23 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
  • 28 of the 126 ancestors have a recall of any class.
  • Of its descendants, K200398 (Stryker GmbH, 2020) has gone furthest, with 9 descendants of its own.
  • 5 other devices also cite its predicate K124027.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

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.

Also cleared against K124027

5 other devices cite the same predicate.

  • K221342REDEMPTION Beaming SystemVilex, LLC · 2022
  • K200987LTJ Screws and WasherAzurmeds, Inc. · 2020
  • K201556Intraosseous Fixation SystemExtremity Medical, LLC · 2020
  • K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
  • K151418Monster Screw SystemParagon 28 · 2015

More from Paragon 28, Inc.

54 FDA decisions under this applicant name. See the company

  • K261120APEX 3D S Diamond TibiaParagon 28, Inc. · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K262047Grappler Suture Anchor SystemParagon 28, Inc. · 2026
  • K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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https://510kreport.com/device/K190586 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190586: Monster® Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190586

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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