510(k) Report

510(k) · Cleared

Cleared

Monster Screw System

K124027510(k) TraditionalCleared Apr 5, 201398-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

Apogee Orthosolutions · HWC Screw, Fixation, Bone

Cleared on Apr 5, 2013 as substantially equivalent to K973309 (Vilex, Inc., 1998) and 17 other predicates after a 98-day review. Its family tree reaches back 10 generations to 1996. 41 later devices descend from it.

Decided
Apr 5, 2013
Review
98 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
18

Its longest line of descent runs back 10 generations to K962616 (1996). 82 ancestors in all, the oldest K792022 (1979). 41 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 2 other ancestors2006: 8 other ancestors2005: 5 other ancestors2002: 4 other ancestors2001: 7 other ancestors1999: 5 other ancestors1998: 4 other ancestors1996: 6 other ancestors1993: 2 other ancestors2008: 2 other ancestors2007: 1 other ancestor2003: 2 other ancestors2000: 7 other ancestors1995: 3 other ancestors1990: 1 other ancestor1989: 2 other ancestors1987: 1 other ancestor1979: 1 other ancestor2004: 4 other ancestors1994: 2 other ancestors1991: 1 other ancestor2017: 3 descendants cleared2015: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2020: 5 descendants cleared2021: 3 descendants cleared2023: 7 descendants cleared2018: 1 descendant cleared2024: 6 descendants cleared2025: 3 descendants cleared2026: 6 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. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 17 other ancestors3 generations back: 15 other ancestors4 generations back: 11 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors7 generations back: 3 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 12 descendants3 generations forward: 12 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K111994 · 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+5
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  4. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  6. This deviceK124027 Monster Screw SystemApogee Orthosolutions · 2013
  7. Descendant · cites it directly · 27 of its ownK151418 Monster Screw SystemParagon 28 · 2015
  8. Descendant · 2 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
  9. Descendant · 2 generations on · 22 of its ownK153378 Monster BITE Screw SystemParagon 28 · 2015
  10. Descendant · cites it directly · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
  11. Descendant · cites it directly · 11 of its ownK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. This deviceK124027 Monster Screw SystemApogee Orthosolutions · 2013

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2015: 22017: 32018: 12019: 22020: 52021: 32022: 32023: 72024: 62025: 32026: 6
2015high 7 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 41 · See all
  • K151418Monster Screw SystemParagon 28 · 2015 · cites it directly27descendants
  • K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 2 generations on24descendants
  • K153378Monster BITE Screw SystemParagon 28 · 2015 · 2 generations on22descendants
  • K190586Monster® Screw SystemParagon 28, Inc. · 2019 · cites it directly21descendants
  • K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017 · cites it directly11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−9K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−8K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−7K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
0 (this device)K124027Monster Screw SystemApogee Orthosolutions2013—
+1K151418Monster Screw SystemParagon 282015—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC2017—
+2K153378Monster BITE Screw SystemParagon 282015—
+1K190586Monster® Screw SystemParagon 28, Inc.2019—
+1K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198710
198920
199010
199110
199320
199420
199530
199660
199840
199950
200070
200170
200240
200320
200440
200550
200680
200710
200820
200920
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201730
201810
201920
202050
202130
202230
202370
202460
202530
202660
FIG. 1 — Lineage of K124027, 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? (18)

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
*K973309Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw
Summary page 1
…om medical grade titanium alloy (per ASTM Fl 36) and stainless steel alloy (per ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428)…
Vilex, Inc.1998—
*K991151Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw
Summary page 1
…medical grade titanium alloy (per ASTM Fl 36) and stainless steel alloy (per ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428)…
Vilex, Inc.1999—
*K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…
Summary page 1
…medical grade titanium alloy (per ASTM Fl 36) and stainless steel alloy (per ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zim…
Vilex, Inc.1999—
*K014154Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…
Summary page 1
…al grade titanium alloy (per ASTM Fl 36) and stainless steel alloy (per ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1…
Vilex, Inc.2002—
*K924018M3 Lag Screw Fixation System
Summary page 1
…inless steel alloy (per ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903])…
Osteomed Corp.1993—
*K060428CSS Cannulated Screw System
Summary page 1
…er ASTM F2229). Predicate Devices: Vilex Inc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and…
Orthohelix Surgical Designs, Inc.20064
*K112885Zimmer Plates and Screws System Screws Only
Summary page 1
…nc (K973309, K991151, K991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc.…
Zimmer, Inc.201115
*K102903Pioneer Cannulated Screw System
Summary page 1
…991197 and K0141 54) OsteoMed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K96…
Pioneer Surgical Technology, Inc.2010—
*K060736Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Summary page 1
…ed Corp. (K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932,…
Smith & Nephew, Inc.20061
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 1
…(K924018) OrthoHelix (K060428) Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 a…
Smith & Nephew, Inc.2009—
*K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…Zimmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst ca…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…mmer, Inc. (K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst case Monster…
Synthes (Usa)1996—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 1
…(K1 12885 [with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst case Monster Screws in…
Synthes (Usa)20011
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…[with Pioneer K1 02903]) Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst case Monster Screws included…
Synthes (Usa)20027
*K050636Synthes 3.0MM Headless Compression Screws
Summary page 1
…Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst case Monster Screws included torsion, in…
Synthes (Usa)20051
*K090949Synthes (Usa) 1.5MM Headless Compression Screws
Summary page 1
…Smith & Nephew (K060736, K090675 and Kil1994) Synthes, Inc. (K96201 1, K962823, K9631 72, K01 2945, K021932, K050636 and K090949) Performance Data: Mechanical testing of the worst case Monster Screws included torsion, insertion/remo…
Synthes (Usa)2009—

Also cleared against K973309: 5 other devices →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K151418Monster Screw SystemParagon 28201527
K190586Monster® Screw SystemParagon 28, Inc.201921
K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711
K200987LTJ Screws and WasherAzurmeds, Inc.20201
K221342REDEMPTION Beaming SystemVilex, LLC20220
K201556Intraosseous Fixation SystemExtremity Medical, LLC20200

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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • 20 of the 82 ancestors have a recall of any class.
  • Of its descendants, K151418 (Paragon 28, 2015) has gone furthest, with 27 descendants of its own.
  • 5 other devices also cite its predicate K973309.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SystemTM 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.

Indications for use as stated in the FDA summary.

Also cleared against K973309

5 other devices cite the same predicate.

  • K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc. · 2019
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K133842Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp. · 2007

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K124027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K124027: 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/K124027

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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