510(k) · Cleared
ClearedSynthes Cortical 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 Dec 5, 2011 as substantially equivalent to K030310 (Synthes (Usa), 2003) and 7 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1996. 118 later devices descend from it.
- Decided
- Dec 5, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K962616 (1996). 85 ancestors in all, the oldest K792022 (1979). 118 later devices descend from it, 28 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · cites it directly · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- Descendant · 2 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- Descendant · 3 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- Descendant · 4 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · cites it directly44descendants
- K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · cites it directly33descendants
- K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 2 generations on23descendants
- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 3 generations on15descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +1 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| +2 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| +3 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| +4 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
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 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 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 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 16 | 0 |
| 2025 | 11 | 0 |
| 2026 | 18 | 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? (8)
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 |
|---|---|---|---|
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 1…Class 11, § 888.3040 - Smooth or Threaded Metallic Bone Fixation Fastener Product Code: HWC Predicate K0303 10 - Synthes Stainless Steel Modular Hand System Device(s): KOI 0321 - Synthes Modular Foot System - 2.7mm… | 2003 |
| * | K010321 | Modular Foot System - 2.7 MM Module | 2001 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 1…0303 10 - Synthes Stainless Steel Modular Hand System Device(s): KOI 0321 - Synthes Modular Foot System - 2.7mm Module K043 185 - Synthes 3.5mm Cortex Screws KI 11230 - Synthes 3.5mm Low Profile Cortical Screws… | 2005 |
| * | K111230 | Synthes 3.5MM Low Profile Cortical Screw | 2011 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…le K043 185 - Synthes 3.5mm Cortex Screws KI 11230 - Synthes 3.5mm Low Profile Cortical Screws K000684- Small Fragment Dynamic Compression Locking (DCL) System K000682 - Synthes Large… | 2000 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…mm Low Profile Cortical Screws K000684- Small Fragment Dynamic Compression Locking (DCL) System K000682 - Synthes Large Fragment Dynamic Compression Locking (DCL) System K 100776 - Syn… | 2000 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 1…System K000682 - Synthes Large Fragment Dynamic Compression Locking (DCL) System K 100776 - Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/M idfoot System K023879-Synthe… | 2010 |
| * | K023879 | Small Titanium Wrist Fusion PlateSummary page 1…Locking (DCL) System K 100776 - Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/M idfoot System K023879-Synthes Small Titanium Wrist Fusion Plate Device Description: Screws have self-tapping features, stardrive, hexdrive, or cru… | 2003 |
What descends from it? (118)
See all 11828 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120854 | Synthes VA LCP Ankle Trauma System | 2012 | 44 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 | 33 |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | 2015 | 14 |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | 2018 | 8 |
| K150981 | SMV Scientific Bone Screws | 2015 | 6 |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate | 2012 | 6 |
| K192745 | DePuy Synthes Trauma Screws | 2019 | 5 |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment… | 2024 | 4 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND… | 2017 | 3 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 85 ancestors have a recall of any class.
- Of its descendants, K120854 (Synthes USA, 2012) has gone furthest, with 44 descendants of its own.
- 15 other devices also cite its predicate K030310.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Synthes I .0mm, 1.3num, 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 Synthes 2.7mm Cortex Screw is intended for fractures and…
Read the full statement (288 words)
The Synthes I .0mm, 1.3num, 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 Synthes 2.7mm Cortex Screw is intended for fractures and osteotomnies 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 hlave fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-2lyears) when used with the Synthes 2.4mmn/2.7mm Variable Angle LCP Fore foot/M idfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The Synthies 3.5mm and 4.0mmn 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 Synthes 4.5imm 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 malunions in adults and in both children (2-12 years) and adolescents (12-2 1 years) 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/K112583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112583: Synthes Cortical Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112583
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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