510(k) · Cleared
ClearedDePuy Synthes 2.0 mm Quick Insertion Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · HWC Screw, Fixation, Bone
Cleared on Nov 21, 2018 as substantially equivalent to K142658 (Biomet Manufacturing Corp, 2014) and 1 other predicate after a 265-day review. Its family tree reaches back 11 generations to 1996. 8 later devices descend from it.
- Decided
- Nov 21, 2018
- Review
- 265 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K962616 (1996). 93 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK180541 DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC · 2018
- Descendant · cites it directly · 5 of its ownK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK222967 Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti…Avanti Orthopaedics, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220319 Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK180541 DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019 · cites it directly5descendants
- K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · 2 generations on2descendants
- K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023 · 3 generations on1descendant
- K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc. · 2022 · cites it directly1descendant
- K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| 0 (this device) | K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Synthes USA Products, LLC | 2018 | — |
| +1 | K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019 | — |
| +2 | K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021 | — |
| +3 | K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023 | — |
| +1 | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics… | Avanti Orthopaedics, Inc. | 2022 | — |
| +2 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142658 | Biomet Headless Compression and Twist-off ScrewsSummary page 4…c bone fixation fastener Regulatory Class: Class II – 888.3040 Product Code: HWC 3. Primary predicate devices Primary Predicate: Zimmer Biomet FRS Twist-off Screw (K142658) Additional Predicate: Synthes 2.0 mm Cortical Screws (K112583) 4. Indications for Use The DePuy Synthes 2.0 mm Quick Ins… | 2014 |
| * | K112583 | Synthes Cortical ScrewsSummary page 4…Product Code: HWC 3. Primary predicate devices Primary Predicate: Zimmer Biomet FRS Twist-off Screw (K142658) Additional Predicate: Synthes 2.0 mm Cortical Screws (K112583) 4. Indications for Use The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions,… | 2011 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.6 years on median.
- 19 of the 93 ancestors have a recall of any class.
- Of its descendants, K192745 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K142658.
How does its category compare?
All HWC devicesHWC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180541: DePuy Synthes 2.0 mm Quick Insertion Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180541
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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