510(k) · Cleared
ClearedWasherCap™ Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abanza Tecnomed S.L · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 25, 2025 as substantially equivalent to K212197 (Abanza Tecnomed S.L, 2022) after a 29-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Feb 25, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922559 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 3 generations backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- 2 generations backK130217 Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. · 2013 · Recalled
- 1 generation backK212197 WasherCap Fixation SystemAbanza Tecnomed S.L · 2022
- This deviceK250238 WasherCap™ Fixation SystemAbanza Tecnomed S.L · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922559 | Acufex Endofix Button | Acufex Microsurgical, Inc. | 1992 | — |
| −3 | K980155 | Endobutton Continuous Loop | Smith & Nephew, Inc. | 1998 | — |
| −2 | K130217 | Orthopediatrics Acl Reconstructive System | OrthoPediatrics Corp. | 2013 | 3 |
| −1 | K212197 | WasherCap Fixation System | Abanza Tecnomed S.L | 2022 | — |
| 0 (this device) | K250238 | WasherCap™ Fixation System | Abanza Tecnomed S.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K212197 | WasherCap Fixation SystemSummary page 5…Predicate Device Manufacturer: Abanza Tecnomed, S.L. Device Name: WasherCapTM Fixation System 510(k) Number: K212197 Product Classification: Class II Regulation Number: 21 CFR 888.3040 Product Code: MB… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K212197.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250238: WasherCap™ Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250238
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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