510(k) · Cleared
ClearedSynthes (Usa) Titanium Locked Spiked Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HTN Washer, Bolt Nut
Cleared on May 12, 1993 after a 252-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 12, 1993
- Review
- 252 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK924455 Synthes (Usa) Titanium Locked Spiked WasherSynthes (Usa) · 1993
- Descendant · cites it directly · 5 of its ownK013806 Synthes Metallic Spiked WashersSynthes (Usa) · 2002
- Descendant · 2 generations on · 2 of its ownK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- Descendant · 3 generations on · 1 of its ownK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · 4 generations on · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
- Descendant · 2 generations on · 0 of its ownK132510 Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013806Synthes Metallic Spiked WashersSynthes (Usa) · 2002 · cites it directly5descendants
- K200028Coronet Soft Tissue Fixation SystemConextions Medical · 2020 · 2 generations on2descendants
- K220966SinefixBAAT Medical Products B.V. · 2023 · 3 generations on1descendant
- K254176SinefixBAAT Medical Products B.V. · 2026 · 4 generations on0descendants
- K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924455 | Synthes (Usa) Titanium Locked Spiked Washer | Synthes (Usa) | 1993 | — |
| +1 | K013806 | Synthes Metallic Spiked Washers | Synthes (Usa) | 2002 | — |
| +2 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| +3 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +4 | K254176 | Sinefix | BAAT Medical Products B.V. | 2026 | — |
| +2 | K132510 | Biopro - Infinity Plate Anchor System | Biopro, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTN? 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 16.4 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013806 | Synthes Metallic Spiked Washers | 2002 | 5 |
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?
- Of its descendants, K013806 (Synthes (Usa), 2002) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K924455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924455: Synthes (Usa) Titanium Locked Spiked Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924455
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026