510(k) · Cleared
Recalled · Class II · 2013Spiked 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 Jan 30, 2002 after a 252-day review. The FDA summary names its predicate without a number. 30 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 2002
- Review
- 252 days
- Class
- Class II
- Product code
- HTN
- Recalls
- 1
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK011583 Spiked WasherSynthes (Usa) · 2002
- Descendant · cites it directly · 23 of its ownK033303 Wafer SystemSpine Wave, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- Descendant · 3 generations on · 11 of its ownK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- Descendant · 4 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK052670 Staxx XD SystemSpine Wave, Inc. · 2006
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K033303Wafer SystemSpine Wave, Inc. · 2004 · cites it directly23descendants
- K053336Staxx FX SystemSpine Wave, Inc. · 2006 · 2 generations on12descendants
- K063606Modification to Staxx FX SystemSpine Wave, Inc. · 2007 · 3 generations on11descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 4 generations on9descendants
- K052670Staxx XD SystemSpine Wave, Inc. · 2006 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011583 | Spiked Washer | Synthes (Usa) | 2002 | — |
| +1 | K033303 | Wafer System | Spine Wave, Inc. | 2004 | — |
| +2 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| +3 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| +4 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +2 | K052670 | Staxx XD System | Spine Wave, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 16.5 · 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 (USA) Spiked Washer Named without a submission number |
What descends from it? (30)
See all 303 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2013 | Class II | Z-0394-2014 | Finished device change control | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033303 (Spine Wave, Inc., 2004) has gone furthest, with 23 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?
Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
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/K011583 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011583: Spiked Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011583
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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