510(k) · Cleared
ClearedSynthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWC Screw, Fixation, Bone
Cleared on Oct 1, 1996 after a 74-day review. The FDA summary names its predicate without a number. 1 of the 837 devices in its family, counting itself, has a Class I recall. 836 later devices descend from it.
- Decided
- Oct 1, 1996
- Review
- 74 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
836 later devices descend from it, 20 citing it directly. 1 of the 837 devices in this family, counting this one, has a Class I recall.
- This deviceK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- Descendant · cites it directly · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 338 of its ownK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- Descendant · 2 generations on · 299 of its ownK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- Descendant · 3 generations on · 255 of its ownK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- Descendant · 4 generations on · 251 of its ownK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
Showing 5 of 836 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 836 · See all- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · cites it directly487descendants
- K993762I.CO.S ScrewNew Deal, S.A. · 2000 · cites it directly338descendants
- K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003 · 2 generations on299descendants
- K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004 · 3 generations on255descendants
- K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 2006 · 4 generations on251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| +1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +1 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| +2 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| +3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| +4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 16 | 0 |
| 2012 | 19 | 0 |
| 2013 | 25 | 0 |
| 2014 | 33 | 0 |
| 2015 | 42 | 0 |
| 2016 | 26 | 0 |
| 2017 | 61 | 0 |
| 2018 | 30 | 0 |
| 2019 | 37 | 0 |
| 2020 | 54 | 0 |
| 2021 | 61 | 1 |
| 2022 | 69 | 0 |
| 2023 | 72 | 0 |
| 2024 | 81 | 0 |
| 2025 | 83 | 0 |
| 2026 | 93 | 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? (1)
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 |
|---|---|---|---|
| * | — | Synthes 2.7 mm Cannulated Screw and Threaded Washer Named without a submission number |
What descends from it? (836)
See all 83620 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | 2009 | 487 |
| K993762 | I.CO.S Screw | 2000 | 338 |
| K013534 | Self-Countersinking Bone Screw | 2001 | 241 |
| K102343 | Emerge Medical Cannulated Screw Fixation System | 2010 | 220 |
| K082874 | Biodrive Cannulated Screw System | 2009 | 168 |
| K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | 2010 | 56 |
| K011821 | Modification to the I.C.O.S Screw | 2001 | 56 |
| K124027 | Monster Screw System | 2013 | 41 |
| K071092 | Asnis Micro Cannulated Screw | 2007 | 38 |
| K112240 | Dyna Locking Cannulated Screw | 2012 | 14 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K090675 (Smith & Nephew, Inc., 2009) has gone furthest, with 487 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962823
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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