510(k) Report

510(k) · Cleared

Cleared

DePuy Synthes Trauma Screws

K192745510(k) TraditionalCleared Nov 26, 201957-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

Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 26, 2019 as substantially equivalent to K000066 (Synthes (Usa), 2000) and 15 other predicates after a 57-day review. Its family tree reaches back 12 generations to 1996. 5 later devices descend from it.

Decided
Nov 26, 2019
Review
57 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
16

Its longest line of descent runs back 12 generations to K962616 (1996). 114 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2008: 5 other ancestors2006: 7 other ancestors2005: 7 other ancestors2004: 6 other ancestors2003: 6 other ancestors2002: 6 other ancestors2000: 10 other ancestors1998: 4 other ancestors1996: 11 other ancestors2014: 1 other ancestor2011: 1 other ancestor2009: 3 other ancestors2001: 9 other ancestors1995: 5 other ancestors2010: 1 other ancestor2007: 3 other ancestors1997: 2 other ancestors1993: 2 other ancestors1999: 3 other ancestors1994: 4 other ancestors1992: 1 other ancestor1990: 1 other ancestor1979: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2022: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2024: 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 · 2011K161616 · DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw · Synthes USA Products, LLC · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 19 other ancestors3 generations back: 11 other ancestors4 generations back: 14 other ancestors5 generations back: 13 other ancestors6 generations back: 13 other ancestors7 generations back: 11 other ancestors8 generations back: 4 other ancestors9 generations back: 1 other ancestor10 generations back: 1 other ancestor11 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants K161616 · DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw · Synthes USA Products, LLC · 2017K112583 · 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 · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  5. 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
  6. This deviceK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
  7. Descendant · cites it directly · 2 of its ownK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
  8. Descendant · 2 generations on · 1 of its ownK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
  9. Descendant · cites it directly · 1 of its ownK220319 Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022
  10. Descendant · 2 generations on · 0 of its ownK233912 ARIX Cannulated Screw SystemJeil Medical Corporation · 2024
  11. Descendant · 2 generations on · 0 of its ownK234040 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024 · Recalled
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  12. 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
  13. This deviceK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019

Most influential descendants

Showing 5 of 5 · See all
  • K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · cites it directly2descendants
  • K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023 · 2 generations on1descendant
  • K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022 · cites it directly1descendant
  • K233912ARIX Cannulated Screw SystemJeil Medical Corporation · 2024 · 2 generations on0descendants
  • K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−2K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
−1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…Synthes USA Products, LLC2017—
0 (this device)K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2019—
+1K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.2021—
+2K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.2023—
+1K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH2022—
+2K233912ARIX Cannulated Screw SystemJeil Medical Corporation2024—
+2K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20242

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199210
199320
199440
199550
1996110
199720
199840
199930
2000100
200190
200260
200360
200460
200570
200670
200730
200850
200930
201010
201110
201410
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202310
202420
FIG. 1 — Lineage of K192745, 1996–2024Source: 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? (16)

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
*K000066Synthes (Usa) Locking Condylar Plate (LCP) System
Summary page 21
…stem – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HTY, HWC, JDW 1.3. Predicate Device K000066 Synthes Locking Condylar Plate (LCP) System 1.4. Device Description The 4.0 mm locking screws feature a self-tapping tip, are…
Synthes (Usa)2000—
*K001720Synthes Sacral Bar System
Summary page 23
…Sacral Bar System – MR Conditional Classification Name(s): Pin, Fixation, Threaded Regulatory Class: Class II; 888.3040 Product Code(s): JDW 1.3. Predicate Device K001720 Synthes Sacral Bar System 1.4. Device Description The DePuy Synthes Sacral Bar System consists of a threaded bar, washers, an…
Synthes (Usa)2000—
*K011583Spiked Washer
Summary page 25
…uy Synthes Spiked Washer – MR Conditional Classification Name(s): Washer, Bolt Nut Regulatory Class: Class II; 888.3030 Product Code(s): HTN 1.3. Predicate Device K011583 Synthes Spiked Washer 1.4. Device Description The DePuy Synthes Spiked Washers are made of PEEK Optima™ LT plymer + 6% barium…
Synthes (Usa)20021
*K032559Synthes 4.0MM Titanium (TI.) Locking Screws
Summary page 27
…(TI) Locking Screws – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K032559 Synthes 4.0 mm Titanium (TI) Locking Screws 1.4. Device Description The DePuy Synthes 4.0 mm Titanium (TI) Locking Screws fea…
Synthes (Usa)2003—
*K040765Synthes 5.0/7.3 MM Cannulated Locking Screws
Summary page 29
…ed Locking Screws – MR Conditional Classification Name(s): Pin, Fixation, Threaded Regulatory Class: Class II; 888.3040 Product Code(s): JDW 1.3. Predicate Device K040765 Synthes 5.0/7.3 mm Cannulated Locking Screws 1.4. Device Description The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws f…
Synthes (Usa)2004—
*K041533Synthes (Usa) [Synthes} Peri-Prosthetic Screws
Summary page 31
…i-Prosthetic Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K041533 Synthes Peri-Prosthetic Screws 1.4. Device Description The DePuy Synthes Peri-Prosthetic Screws feature a self-tapping blunt…
Synthes (Usa)20041
*K050683Synthes (Usa) 3.5MM Conical Screws
Summary page 33
…5 mm Conical Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K050683 Synthes 3.5mm Conical Screws 1.4. Device Description The DePuy Synthes 3.5 mm Conical Screws are self-tapping, have a stardri…
Synthes (Usa)20051
*K052483Synthes (Usa) Spherical Washers
Summary page 35
…R Conditional Classification Name(s): Washer, Bolt, Nut, Non-Spinal, Metallic Regulatory Class: Class II; 888.3030 Product Code(s): NDG, HWC 1.3. Predicate Device K052483 Synthes Spherical Washers 1.4. Device Description The DePuy Synthes Spherical Washers are round or oval in design with a slot…
Synthes (Usa)2005—
*K061621Synthes (Usa) 6.5 MM Cancellous Screws
Summary page 37
…m Cancellous Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K061621 Synthes 6.5 mm Cancellous Screws 1.4. Device Description The DePuy Synthes 6.5 mm Cancellous Screws incorporate a fully threa…
Synthes (Usa)2006—
*K081071Synthes 6.5MM Midfoot Fusion Bolt
Summary page 39
…Midfoot Fusion Bolt – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K081071 Synthes 6.5 mm Midfoot Fusion Bolt 1.4. Device Description The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is a solid metallic f…
Synthes (Usa)20081
*K112583Synthes Cortical Screws
Summary page 41
…hes Cortical Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K112583 Synthes Cortical Screws 1.4. Device Description The DePuy Synthes Cortical Screws have self-tapping features, stardrive, hexd…
Synthes (USA) Products, LLC2011—
*K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…
Summary page 43
…ion Screws (6.5 mm) – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K161616 DePuy Synthes Cortex Screws (4.0 mm and 4.5 mm), DePuy Synthes Cannulated Screws (2.4 mm, 3.5 mm , 4.0 mm , 4.5 mm , 6.5 mm , 7.0…
Synthes USA Products, LLC2017—
*K180541DePuy Synthes 2.0 mm Quick Insertion Screws
Summary page 47
…ck Insertion Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K180541 DePuy Synthes 2.0 mm Quick Insertion Screws 1.4. Device Description The DePuy Synthes 2.0 mm Quick Insertion Screws (QI Screw…
Synthes USA Products, LLC2018—
*K961413Synthes Anatomical Locking Plate System
Summary page 49
…em (ALPS) – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC, HRS, JDS 1.3. Predicate Device K961413 Synthes Anatomical Locking Plate System (ALPS) 1.4. Device Description The DePuy Synthes ALPS is a plate and screw system int…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 51
…hreaded Washer – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC, HTN 1.3. Predicate Device K962823 Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer 1.4. Device Description The 3.0 mm Cannulated Screw has a 3.0 mm…
Synthes (Usa)1996—
*K974537Synthes Cannulated Angle Blade Plate (Cabp) System
Summary page 53
…tion Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II; 888.3030 Product Code(s): KTT 1.3. Predicate Device K974537 Synthes Cannulated Angle Blade Plate (CAEP) System 1.4. Device Description The DePuy Synthes Cannulated Angle Blade Plate is…
Synthes (Usa)1998—

Also cleared against K000066: 8 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212
K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221

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.
  • 24 of the 114 ancestors have a recall of any class.
  • Of its descendants, K211783 (TriMed, Inc., 2021) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K000066.

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 DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions. The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine…

Read the full statement (1,633 words)

The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The DePuy Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically re-adaptation of torn or avulsed ligaments.

The DePuy Synthes 4.0 mm Titanium Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

The DePuy Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with DePuy Synthes Locking Plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm Conical Screws are intended to be used with existing DePuy Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments.

In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

DePuy Synthes 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

DePuy Synthes 6.5 mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

The DePuy Synthes 1.0mm, 1.3mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2. 7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the DePuy Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the DePuy Synthes Ti Wrist Fusion Plate (K023879).

The DePuy Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.

The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures, non-unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula, and femur.

The DePuy Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K192745: DePuy Synthes Trauma Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192745

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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