510(k) · Cleared
ClearedCancellous Screw Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Biosystems, Ltd. · HTN Washer, Bolt Nut
Cleared on Nov 15, 1996 after a 77-day review. The FDA summary names its predicate without a number. 1 of the 340 devices in its family, counting itself, has a Class I recall. 339 later devices descend from it.
- Decided
- Nov 15, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 0
339 later devices descend from it, 2 citing it directly. 1 of the 340 devices in this family, counting this one, has a Class I recall.
- This deviceK963420 Cancellous Screw WasherOrthopaedic Biosystems, Ltd. · 1996
- 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
- Descendant · 5 generations on · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
Showing 5 of 339 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 339 · See all- 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
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · 5 generations on246descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963420 | Cancellous Screw Washer | Orthopaedic Biosystems, Ltd. | 1996 | — |
| +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 | — |
| +5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 19 | 0 |
| 2016 | 11 | 0 |
| 2017 | 23 | 0 |
| 2018 | 10 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 26 | 1 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 31 | 0 |
| 2025 | 32 | 0 |
| 2026 | 45 | 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 Screw Washer Named without a submission number |
What descends from it? (339)
See all 3392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K993762 (New Deal, S.A., 2000) has gone furthest, with 338 descendants of its own.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
These implants are intended for fracture fixation of the metatarsals, metacarpals, and tarsal bones.
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/K963420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963420: Cancellous Screw Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963420
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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