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 Sep 22, 2022 as substantially equivalent to K130217 (OrthoPediatrics Corp., 2013) after a 435-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 22, 2022
- Review
- 435 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922559 (1992). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 2 generations backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- 1 generation backK130217 Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. · 2013 · Recalled
- This deviceK212197 WasherCap Fixation SystemAbanza Tecnomed S.L · 2022
- Descendant · cites it directly · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · 2 generations on · 0 of its ownK253618 QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026
- Descendant · cites it directly · 0 of its ownK250238 WasherCap™ Fixation SystemAbanza Tecnomed S.L · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922559 | Acufex Endofix Button | Acufex Microsurgical, Inc. | 1992 | — |
| −2 | K980155 | Endobutton Continuous Loop | Smith & Nephew, Inc. | 1998 | — |
| −1 | K130217 | Orthopediatrics Acl Reconstructive System | OrthoPediatrics Corp. | 2013 | 3 |
| 0 (this device) | K212197 | WasherCap Fixation System | Abanza Tecnomed S.L | 2022 | — |
| +1 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +2 | K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K130217 | Orthopediatrics Acl Reconstructive SystemSummary page 4…MBI 5.3 Equivalence Claimed to Predicate Device The WasherCap™ Fixation System is equivalent to the OrthoPediatrics ACL Reconstruction System (K130217), manufactured by OrthoPediatrics, Corp.. 5.4 Device Description… | 2013 |
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K243712 (Abanza Tecnomed S.L, 2025) has gone furthest, with 1 descendant of its own.
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. 2022, 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 TM 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/K212197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212197: 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/K212197
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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