510(k) · Cleared
ClearedSmith & Nephew Cannulated Screws and Washers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 11, 2011 as substantially equivalent to K090675 (Smith & Nephew, Inc., 2009) and 6 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1996. 1 of the 227 devices in its family, counting itself, has a Class I recall. 161 later devices descend from it.
- Decided
- Oct 11, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K962616 (1996). 65 ancestors in all, the oldest K792022 (1979). 161 later devices descend from it, 16 citing it directly. 1 of the 227 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- This deviceK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · cites it directly · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 41 of its ownK124027 Monster Screw SystemApogee Orthosolutions · 2013
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- This deviceK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 161 · See all- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · cites it directly74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
- K124027Monster Screw SystemApogee Orthosolutions · 2013 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +1 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +1 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +1 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
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 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 1 |
| 2022 | 14 | 0 |
| 2023 | 19 | 0 |
| 2024 | 23 | 0 |
| 2025 | 21 | 0 |
| 2026 | 29 | 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 3…foot and ankle. Technological Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indic… | 2009 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 3…ankle. Technological Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications fo… | 2008 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 3…== Page 3 === Technological Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and… | 2007 |
| * | K102903 | Pioneer Cannulated Screw SystemSummary page 3…=== Technological Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended… | 2010 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 3…nological Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended use, are… | 2002 |
| * | K052483 | Synthes (Usa) Spherical WashersSummary page 3…Characteristics The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended use, are manufactu… | 2005 |
| * | K003496 | Cannulated Screw SystemSummary page 3…cs The Smith &Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021 932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended use, are manufactured from simi… | 2001 |
What descends from it? (161)
See all 16116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143039 | CrossRoads Screw System | 2015 | 79 |
| K162825 | CAPTIVATE™ Compression Screws | 2017 | 74 |
| K124027 | Monster Screw System | 2013 | 41 |
| K140741 | Salvation Beams and Bolts System | 2014 | 34 |
| K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | 2014 | 15 |
| K152686 | Conquest FN | 2016 | 12 |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | 2017 | 11 |
| K193029 | Conquest FN | 2020 | 10 |
| K172785 | Conquest FN | 2017 | 8 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 15 of the 65 ancestors have a recall of any class.
- Of its descendants, K143039 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) has gone furthest, with 79 descendants of its own.
- 22 other devices also cite its predicate K090675.
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?
Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 4.0mm Cannulated Screws and…
Read the full statement (141 words)
Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation.
Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111994: Smith & Nephew Cannulated Screws and Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111994
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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