510(k) · Cleared
ClearedSoft Tissue Suture Washer/3 Hole Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HTN Washer, Bolt Nut
Cleared on Jul 24, 1991 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 24, 1991
- Review
- 187 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK910229 Soft Tissue Suture Washer/3 Hole WasherDepuy, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK994202 Acufex Spiked Washer System, Acufex Suture Washer System, Acufex…Smith & Nephew, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK183628 Arthrex TensionLoc SystemArthrex, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK991135 Soft Tissue Suture WasherDepuy, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K994202Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and…Smith & Nephew, Inc. · 2000 · cites it directly1descendant
- K183628Arthrex TensionLoc SystemArthrex, Inc. · 2019 · 2 generations on0descendants
- K991135Soft Tissue Suture WasherDepuy, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910229 | Soft Tissue Suture Washer/3 Hole Washer | Depuy, Inc. | 1991 | — |
| +1 | K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous… | Smith & Nephew, Inc. | 2000 | — |
| +2 | K183628 | Arthrex TensionLoc System | Arthrex, Inc. | 2019 | — |
| +1 | K991135 | Soft Tissue Suture Washer | Depuy, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2019 | 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 16.5 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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, K994202 (Smith & Nephew, Inc., 2000) has gone furthest, with 1 descendant 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/K910229 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910229: Soft Tissue Suture Washer/3 Hole Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910229
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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