510(k) · Cleared
ClearedSynthes Metallic Spiked Washers
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 Feb 8, 2002 as substantially equivalent to K914472 (Synthes (Usa), 1991) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Feb 8, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914472 (1991). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914472 Spiked WasherSynthes (Usa) · 1991
- This deviceK013806 Synthes Metallic Spiked WashersSynthes (Usa) · 2002
- Descendant · cites it directly · 2 of its ownK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- Descendant · 2 generations on · 1 of its ownK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · 3 generations on · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
- Descendant · cites it directly · 0 of its ownK132510 Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111008 Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K200028Coronet Soft Tissue Fixation SystemConextions Medical · 2020 · cites it directly2descendants
- K220966SinefixBAAT Medical Products B.V. · 2023 · 2 generations on1descendant
- K254176SinefixBAAT Medical Products B.V. · 2026 · 3 generations on0descendants
- K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013 · cites it directly0descendants
- K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914472 | Spiked Washer | Synthes (Usa) | 1991 | — |
| 0 (this device) | K013806 | Synthes Metallic Spiked Washers | Synthes (Usa) | 2002 | — |
| +1 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| +2 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +3 | K254176 | Sinefix | BAAT Medical Products B.V. | 2026 | — |
| +1 | K132510 | Biopro - Infinity Plate Anchor System | Biopro, Inc. | 2013 | — |
| +1 | K111008 | Microware Bone Plates and Bone Screw | Microware Precision Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K914472 | Spiked WasherSummary page 3…for the Synthes Metallic Spiked Washer are the Synthes Spiked Washer and the Synthes Titanium Locked Spiked Washer which were cleared via 510(k) premarket notifications #K 914472 and #K 924455 respectively. All these devices have the same indications, are made of the same material(s), have similar features,… | 1991 |
| * | K924455 | Synthes (Usa) Titanium Locked Spiked WasherSummary page 3…s Metallic Spiked Washer are the Synthes Spiked Washer and the Synthes Titanium Locked Spiked Washer which were cleared via 510(k) premarket notifications #K 914472 and #K 924455 respectively. All these devices have the same indications, are made of the same material(s), have similar features, and are avail… | 1993 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
The Metallic spiked washers are indicated for ligament reattachment or fixation.
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/K013806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013806: Synthes Metallic Spiked Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013806
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026