510(k) Report

510(k) · Cleared

Cleared

SurgTech Trauma System

K161894510(k) TraditionalCleared Feb 21, 2017225-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

Surgtech, Inc. · HWC Screw, Fixation, Bone

Cleared on Feb 21, 2017 as substantially equivalent to K092493 (Gpc Medical, Ltd., 2010) and 29 other predicates after a 225-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.

Decided
Feb 21, 2017
Review
225 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
30

Its longest line of descent runs back 11 generations to K962616 (1996). 176 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2012: 1 other ancestor2010: 5 other ancestors2009: 7 other ancestors2008: 6 other ancestors2007: 5 other ancestors2006: 14 other ancestors2005: 14 other ancestors2004: 13 other ancestors2003: 10 other ancestors2002: 8 other ancestors2000: 16 other ancestors1999: 4 other ancestors1996: 13 other ancestors1992: 2 other ancestors2011: 1 other ancestor2001: 15 other ancestors1998: 11 other ancestors1995: 4 other ancestors1990: 1 other ancestor1979: 1 other ancestor1991: 2 other ancestors1989: 2 other ancestors1994: 5 other ancestors1993: 2 other ancestors1997: 1 other ancestor2024: 1 descendant cleared2026: 2 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. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 28 other ancestors2 generations back: 48 other ancestors3 generations back: 41 other ancestors4 generations back: 22 other ancestors5 generations back: 15 other ancestors6 generations back: 11 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 2011K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · 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 · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  5. 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  6. This deviceK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
  7. Descendant · cites it directly · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  8. Descendant · 2 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
  9. Descendant · 2 generations on · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  12. This deviceK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · cites it directly2descendants
  • K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 2 generations on0descendants
  • K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
0 (this device)K161894SurgTech Trauma SystemSurgtech, Inc.2017—
+1K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+2K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System…Ortler Global Tibbi Gerecler Anonim Sirketi2026—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198920
199010
199120
199220
199320
199450
199540
1996130
199710
1998110
199940
2000160
2001150
200280
2003100
2004130
2005140
2006140
200750
200860
200970
201050
201110
201210
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202620
FIG. 1 — Lineage of K161894, 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
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What was it cleared against? (30)

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
*K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System
Summary page 5
…Ti6Al7Nb per ASTM F1295) and stainless steel (ASTM F138). Primary Predicate GPC Bone Plates and Bone Screws (GPC Medical K092493) (plate & screw system): K161894…
Gpc Medical, Ltd.2010—
*K100111NCB Periprosthetic Femur Polyaxial Locking Plate System
Summary page 6
…K161894 Pg.2/2 Additional Predicates The NCB Periprosthetic Femur Polyaxial Locking Plate System (Zimmer (plate & screw system): Inc. K100111), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.TS. Volar Radius Plate (I.T.S. GmbH K033756), I.T.S. Ole…
Zimmer, Inc.20102
*K060156Straight Plate with Angular Stability & Screw System
Summary page 6
…2 Additional Predicates The NCB Periprosthetic Femur Polyaxial Locking Plate System (Zimmer (plate & screw system): Inc. K100111), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.TS. Volar Radius Plate (I.T.S. GmbH K033756), I.T.S. Olecranon Plate (I.T.S. GmbH…
I.T.S. Implantat-Technologie-Systeme GmbH20062
*K033756Volar Radius Plate with Angular Stability
Summary page 6
…ng Plate System (Zimmer (plate & screw system): Inc. K100111), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.TS. Volar Radius Plate (I.T.S. GmbH K033756), I.T.S. Olecranon Plate (I.T.S. GmbH K052368), Synthes Variable Angle LCP Elbow System (Synthes, K120070…
I.T.S. Implantat-Technologie-Systeme GmbH20041
*K052368Olecranonplate with Angular Stability
Summary page 6
…Straight Plate (I.T.S. GmbH K060156), I.TS. Volar Radius Plate (I.T.S. GmbH K033756), I.T.S. Olecranon Plate (I.T.S. GmbH K052368), Synthes Variable Angle LCP Elbow System (Synthes, K120070), I.T.S. Distal Humeral Plates (I.T.S. GmbH K…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K120070Synthes Variable Angle LCP Elbow System
Summary page 6
…Radius Plate (I.T.S. GmbH K033756), I.T.S. Olecranon Plate (I.T.S. GmbH K052368), Synthes Variable Angle LCP Elbow System (Synthes, K120070), I.T.S. Distal Humeral Plates (I.T.S. GmbH K080184), I.T.S. Straight Plate (I.T.…
Synthes USA20121
*K080184Distal Humeral Plates with Angular Stability
Summary page 6
…T.S. GmbH K052368), Synthes Variable Angle LCP Elbow System (Synthes, K120070), I.T.S. Distal Humeral Plates (I.T.S. GmbH K080184), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.T.S. Claviculatplate (I.T.S. GmbH K050852),…
I.T.S. Implantat-Technologie-Systeme GmbH20081
*K050852Claviculaplate with Angular Stablity Bone Plate System
Summary page 6
…I.T.S. Distal Humeral Plates (I.T.S. GmbH K080184), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.T.S. Claviculatplate (I.T.S. GmbH K050852), Synthes (USA) Clavicle Hook Plate (Synthes, K031677), Synthes (USA) LCP® Proxim…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K031677Synthes (Usa) Calvicle Hook Plate
Summary page 6
…ht Plate (I.T.S. GmbH K060156), I.T.S. Claviculatplate (I.T.S. GmbH K050852), Synthes (USA) Clavicle Hook Plate (Synthes, K031677), Synthes (USA) LCP® Proximal Humerus Plates (Synthes K041860), the I.T.S. Pelvic…
Synthes (Usa)2003—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 6
…GmbH K050852), Synthes (USA) Clavicle Hook Plate (Synthes, K031677), Synthes (USA) LCP® Proximal Humerus Plates (Synthes K041860), the I.T.S. Pelvic Reconstruction System (I.T.S. GmbH K063166), I.T.S. Fibula Plate (I.T.S.…
Synthes (Usa)2004—
*K063166I.T.S. Pelvic Reconstruction System
Summary page 6
…1677), Synthes (USA) LCP® Proximal Humerus Plates (Synthes K041860), the I.T.S. Pelvic Reconstruction System (I.T.S. GmbH K063166), I.T.S. Fibula Plate (I.T.S. GmbH K063672), DePuy ALPS (DePuy Orthopaedics K082300), Acumed…
I.T.S. Implantat-Technologie-Systeme GmbH20062
*K063672Fibula Plate Prolock with Angular Stability
Summary page 6
…Plates (Synthes K041860), the I.T.S. Pelvic Reconstruction System (I.T.S. GmbH K063166), I.T.S. Fibula Plate (I.T.S. GmbH K063672), DePuy ALPS (DePuy Orthopaedics K082300), Acumed Hand Fracture System (Acumed LLC K141383), Synthes Lock…
I.T.S. Implantat-Technologie-Systeme GmbH20071
*K082300Anatomic Locking Plating System
Summary page 6
…ic Reconstruction System (I.T.S. GmbH K063166), I.T.S. Fibula Plate (I.T.S. GmbH K063672), DePuy ALPS (DePuy Orthopaedics K082300), Acumed Hand Fracture System (Acumed LLC K141383), Synthes Locking Calcaneal Pla…
DePuy Orthopaedics, Inc.20092
*K141383Acumed Hand Fracture System
Summary page 6
…T.S. Fibula Plate (I.T.S. GmbH K063672), DePuy ALPS (DePuy Orthopaedics K082300), Acumed Hand Fracture System (Acumed LLC K141383), Synthes Locking Calcaneal Plates (Synthes K991407), I.T.S. Calcaneus Repair System…
Acumed, LLC2014—
*K991407Synthes Locking Calcaneal Plates
Summary page 6
…(DePuy Orthopaedics K082300), Acumed Hand Fracture System (Acumed LLC K141383), Synthes Locking Calcaneal Plates (Synthes K991407), I.T.S. Calcaneus Repair System (I.T.S. GmbH K051642), Synthes 2.4 mm / 2.7 mm Variable Angle (VA), -…
Synthes (Usa)1999—
*K051642FR.O.H. Calcaneus Repair System
Summary page 6
…tem (Acumed LLC K141383), Synthes Locking Calcaneal Plates (Synthes K991407), I.T.S. Calcaneus Repair System (I.T.S. GmbH K051642), Synthes 2.4 mm / 2.7 mm Variable Angle (VA), - LCP Forefoot /Midfoot System (Synthes K100776) and Medar…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System
Summary page 6
…Repair System (I.T.S. GmbH K051642), Synthes 2.4 mm / 2.7 mm Variable Angle (VA), - LCP Forefoot /Midfoot System (Synthes K100776) and Medartis APTUS® Foot System (Medartis K091479), Synthes Titanium Small Reconstruction…
Synthes (Usa)2010—
*K091479Aptus Foot System
Summary page 6
…/ 2.7 mm Variable Angle (VA), - LCP Forefoot /Midfoot System (Synthes K100776) and Medartis APTUS® Foot System (Medartis K091479), Synthes Titanium Small Reconstruction Plate (Synthes K915818), Synthes Large Fragment Dynamic Compressi…
Medartis AG20092
*K915818Synthes (R) Titanium Small Reconstruction Plate
Summary page 6
…Synthes K100776) and Medartis APTUS® Foot System (Medartis K091479), Synthes Titanium Small Reconstruction Plate (Synthes K915818), Synthes Large Fragment Dynamic Compression Locking (DCL) System (Synthes K000682), Synthes Small Fragme…
Synthes (Usa)19922
*K000682Synthes Large Fragment Dynamic Compression Locking (DCL) System
Summary page 6
…um Small Reconstruction Plate (Synthes K915818), Synthes Large Fragment Dynamic Compression Locking (DCL) System (Synthes K000682), Synthes Small Fragment Dynamic Compression Locking (DCL) (System K000684), 1.5mm Mini…
Synthes (Usa)2000—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 6
…amic Compression Locking (DCL) System (Synthes K000682), Synthes Small Fragment Dynamic Compression Locking (DCL) (System K000684), 1.5mm Mini Fragment LCP System (Synthes K090047). Primary Predicate OsteoMed H…
Synthes (Usa)20001
*K090047Synthes (Usa) 1.5MM Mini Fragment LCP System
Summary page 6
…0682), Synthes Small Fragment Dynamic Compression Locking (DCL) (System K000684), 1.5mm Mini Fragment LCP System (Synthes K090047). Primary Predicate OsteoMed Headless Cannulated Screw System (OsteoMed LP K063298) (standalone screws):…
Synthes (Usa)2009—
*K063298Osteomed Headless Cannulated Screw System
Summary page 6
…5mm Mini Fragment LCP System (Synthes K090047). Primary Predicate OsteoMed Headless Cannulated Screw System (OsteoMed LP K063298) (standalone screws): Additional Predicates Treu Bone fixation Screws and Pins (Treu Instrumente GmbH K083912), (standalone sc…
Osteomed LP2007—
*K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins
Summary page 6
…OsteoMed Headless Cannulated Screw System (OsteoMed LP K063298) (standalone screws): Additional Predicates Treu Bone fixation Screws and Pins (Treu Instrumente GmbH K083912), (standalone screws): Synthes Cortical Screws (Synthes K112583), Synthes 3.0 mm Headless Compressio…
Treu-Instrumente GmbH2009—
*K112583Synthes Cortical Screws
Summary page 6
…tandalone screws): Additional Predicates Treu Bone fixation Screws and Pins (Treu Instrumente GmbH K083912), (standalone screws): Synthes Cortical Screws (Synthes K112583), Synthes 3.0 mm Headless Compression Screws (Synthes K050636), Synthes 4.5 mm and 6.5 mm…
Synthes (USA) Products, LLC2011—
*K050636Synthes 3.0MM Headless Compression Screws
Summary page 6
…strumente GmbH K083912), (standalone screws): Synthes Cortical Screws (Synthes K112583), Synthes 3.0 mm Headless Compression Screws (Synthes K050636), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (Synthes K080943), Vilex Bone Screw…
Synthes (Usa)20051
*K080943Synthes 4.5 MM and 6.5 MM Headless Compression Screws
Summary page 6
…es 3.0 mm Headless Compression Screws (Synthes K050636), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (Synthes K080943), Vilex Bone Screw (Vilex K014154), Synthes 7.0/7.3 mm Cannulated Screws (Synthes…
Synthes (Usa)2008—
*K014154Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…
Summary page 6
…ews (Synthes K050636), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (Synthes K080943), Vilex Bone Screw (Vilex K014154), Synthes 7.0/7.3 mm Cannulated Screws (Synthes K962011), SBi Foot and Ankle Cannulated Screws (Small Bo…
Vilex, Inc.2002—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 6
…s Compression Screws (Synthes K080943), Vilex Bone Screw (Vilex K014154), Synthes 7.0/7.3 mm Cannulated Screws (Synthes K962011), SBi Foot and Ankle Cannulated Screws (Small Bone Innovations K092754) Performance Data: Mechani…
Synthes (Usa)1996—
*K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061
Summary page 6
…), Synthes 7.0/7.3 mm Cannulated Screws (Synthes K962011), SBi Foot and Ankle Cannulated Screws (Small Bone Innovations K092754) Performance Data: Mechanical testing of the worst case SurgTech Trauma System plates included st…
Small Bone Innovations, Inc.2010—

Also cleared against K092493: 3 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242

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 21 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 41 of the 176 ancestors have a recall of any class.
  • Of its descendants, K242939 (Artfx Medical, 2024) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K092493.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device. The large plate set components are indicated for the use in various long bones including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, radius, ulna, pelvis, tibia and…

Read the full statement (135 words)

The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.

The large plate set components are indicated for the use in various long bones including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacarpals, metatarsals, phalanges, calcaneus and those of the ankle.

In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws 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 as stated in the FDA summary.

Also cleared against K092493

3 other devices cite the same predicate.

  • K153573ConvergeBiomedical Enterprises, Inc. · 2016
  • K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 2015
  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011

More from Surgtech, Inc.

6 FDA decisions under this applicant name. See the company

  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  • K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
  • K152200SurgTech Interbody SystemSurgtech, Inc. · 2016

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/K161894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161894: SurgTech Trauma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161894

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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