510(k) · Cleared
ClearedAcumed Suture Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu Med, Inc. · HTN Washer, Bolt Nut
Cleared on Mar 17, 1997 after a 90-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 17, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK965028 Acumed Suture WasherAcu Med, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK990392 Depuy Ace Spider PlateDepuy Ace Medical Co. · 1999
- Descendant · 2 generations on · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
- Descendant · cites it directly · 0 of its ownK984458 Depuy Ace Spider PlateDepuy Ace Medical Co. · 1998
Most influential descendants
Showing 4 of 4 · See all- K990392Depuy Ace Spider PlateDepuy Ace Medical Co. · 1999 · cites it directly2descendants
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · 2 generations on1descendant
- K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 3 generations on0descendants
- K984458Depuy Ace Spider PlateDepuy Ace Medical Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965028 | Acumed Suture Washer | Acu Med, Inc. | 1997 | — |
| +1 | K990392 | Depuy Ace Spider Plate | Depuy Ace Medical Co. | 1999 | — |
| +2 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| +3 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
| +1 | K984458 | Depuy Ace Spider Plate | Depuy Ace Medical Co. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 1 | 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 16.4 · 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? (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 |
|---|---|---|---|
| * | — | Linvatec Spiked Washer Named without a submission number |
What descends from it? (4)
2 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?
- Of its descendants, K990392 (Depuy Ace Medical Co., 1999) has gone furthest, with 2 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?
The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.
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/K965028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965028: Acumed Suture Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965028
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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