510(k) Report

510(k) · Cleared

Cleared

SILVERBACK Gorilla Plating System

K182148510(k) SpecialCleared Sep 7, 201830-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 Sep 7, 2018 as substantially equivalent to K140397 (Paragon 28, 2014) and 3 other predicates after a 30-day review. Its family tree reaches back 14 generations to 1996. 3 later devices descend from it.

Decided
Sep 7, 2018
Review
30 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 14 generations to K954385 (1996). 225 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2012: 4 other ancestors2013: 1 other ancestor2011: 7 other ancestors2010: 9 other ancestors2009: 10 other ancestors2008: 7 other ancestors2007: 5 other ancestors2006: 14 other ancestors2005: 17 other ancestors2004: 9 other ancestors2003: 8 other ancestors2002: 18 other ancestors2001: 21 other ancestors1993: 3 other ancestors2000: 13 other ancestors1999: 9 other ancestors1996: 15 other ancestors1998: 9 other ancestors1995: 7 other ancestors1994: 7 other ancestors1991: 1 other ancestor1989: 1 other ancestor1992: 3 other ancestors1990: 5 other ancestors1997: 6 other ancestors1979: 1 other ancestor2021: 1 descendant cleared2020: 2 descendants clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998×2: 2 generations cleared close together, K030448 (2003), K032442 (2003) K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalled×2: 2 generations cleared close together, K100618 (2010), K102156 (2010) K111041 · Mini Variable System · Orthohelix Surgical Designs, Inc. · 2011×2: 2 generations cleared close together, K120157 (2012), K121437 (2012) K140397 · Paralock Plating System / Tuffnek Screw · Paragon 28 · 2014K172886 · Breakaway Screw System · Paragon 28 · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 24 other ancestors3 generations back: 29 other ancestors4 generations back: 41 other ancestors5 generations back: 30 other ancestors6 generations back: 27 other ancestors7 generations back: 26 other ancestors8 generations back: 21 other ancestors9 generations back: 8 other ancestors10 generations back: 2 other ancestors11 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant K172886 · Breakaway Screw System · Paragon 28 · 2017K140397 · Paralock Plating System / Tuffnek Screw · Paragon 28 · 2014K121437 · Mini Maxlock Extreme Plating System · Orthohelix Surgical Designs, Inc. · 2012K120157 · Mini Maxlock Extreme Plating System · Orthohelix Surgical Designs, Inc. · 2012K111041 · Mini Variable System · Orthohelix Surgical Designs, Inc. · 2011K102156 · Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws · Orthohelix Surgical Designs, Inc. · 2010 · recalledK100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 2010K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996−10−50
  1. Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 10 generations between
  3. 3 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  4. 2 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  5. 1 generation backK172886 Breakaway Screw SystemParagon 28 · 2017
  6. This deviceK182148 SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018
  7. Descendant · cites it directly · 1 of its ownK200762 CoLink Cfx Plating SystemIn2bones USA, LLC · 2020
  8. Descendant · cites it directly · 0 of its ownK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
  9. Descendant · 2 generations on · 0 of its ownK201149 CoLink Plating SystemIn2bones USA, LLC · 2020
Show all 14 generations
  1. Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  8. 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  9. 6 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
  10. 5 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
  11. 4 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  12. 3 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  13. 2 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  14. 1 generation backK172886 Breakaway Screw SystemParagon 28 · 2017
  15. This deviceK182148 SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K200762CoLink Cfx Plating SystemIn2bones USA, LLC · 2020 · cites it directly1descendant
  • K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021 · cites it directly0descendants
  • K201149CoLink Plating SystemIn2bones USA, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−13K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−12K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−11K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−10K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−9K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
−8K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
−7K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
−6K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101
−5K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.2011—
−4K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
−3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
−2K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
−1K172886Breakaway Screw SystemParagon 282017—
0 (this device)K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.2018—
+1K200762CoLink Cfx Plating SystemIn2bones USA, LLC2020—
+1K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.2021—
+2K201149CoLink Plating SystemIn2bones USA, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199050
199110
199230
199330
199470
199570
1996150
199760
199890
199990
2000130
2001210
2002180
200380
200490
2005170
2006140
200750
200870
2009100
201090
201170
201240
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202110
FIG. 1 — Lineage of K182148, 1996–2021Source: 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? (4)

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
*K140397Paralock Plating System / Tuffnek Screw
Summary page 5
…for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Primary Predicate: K 140397, BABY GORILLA®/GORILLA® Plating System (formerly ParaLock Plating System), Paragon 28, Inc. Additional Predicates: K 172886, BA…
Paragon 282014—
*K172886Breakaway Screw System
Summary page 5
…he size of the device. Primary Predicate: K 140397, BABY GORILLA®/GORILLA® Plating System (formerly ParaLock Plating System), Paragon 28, Inc. Additional Predicates: K 172886, BABY GORILLA®/GORILLA® Breakaway Screw System, Paragon 28, Inc. K121425, ORTHOLOC™ 3Di Ankle Fusion System, Wright Medical Tech…
Paragon 282017—
*K121425Ortholoc 3DI Ankle Fusion Plating System
Summary page 5
…® Plating System (formerly ParaLock Plating System), Paragon 28, Inc. Additional Predicates: K 172886, BABY GORILLA®/GORILLA® Breakaway Screw System, Paragon 28, Inc. K121425, ORTHOLOC™ 3Di Ankle Fusion System, Wright Medical Technology, Inc. K141735, Ankle Fusion Plating System, Arthrex, Inc. Perform…
Wrightmedicaltechnologyinc2012—
*K141735Arthrex Ankle Fusion Plating System
Summary page 5
…onal Predicates: K 172886, BABY GORILLA®/GORILLA® Breakaway Screw System, Paragon 28, Inc. K121425, ORTHOLOC™ 3Di Ankle Fusion System, Wright Medical Technology, Inc. K141735, Ankle Fusion Plating System, Arthrex, Inc. Performance Data: Engineering analysis is presented to provide evidence that the or…
Arthrex, Inc.20141

Also cleared against K140397: 6 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201
K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210

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 22 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
  • 45 of the 225 ancestors have a recall of any class.
  • Of its descendants, K200762 (In2bones USA, LLC, 2020) has gone furthest, with 1 descendant of its own.
  • 6 other devices also cite its predicate K140397.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

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 K140397

6 other devices cite the same predicate.

  • K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
  • K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc. · 2017
  • K172886Breakaway Screw SystemParagon 28 · 2017
  • K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  • K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017

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

  • 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/K182148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182148: SILVERBACK Gorilla Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182148

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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