510(k) · Cleared
ClearedWasherCap™ Mini Fixation System (Model 45)
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 Jan 30, 2025 as substantially equivalent to K203495 (Arthrex, Inc., 2021) and 2 other predicates after a 59-day review. Its family tree reaches back 12 generations to 1979. 1 later device descends from it.
- Decided
- Jan 30, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K792022 (1979). 98 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 2 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 1 generation backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- This deviceK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · cites it directly · 0 of its ownK253618 QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 5 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 4 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 3 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 2 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 1 generation backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- This deviceK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
Most influential descendants
Showing 1 of 1 · See all- K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −5 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −4 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| −2 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| −1 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| 0 (this device) | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +1 | K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K203495 | Arthrex SwiveLock AnchorSummary page 5…Devices Primary Predicate Manufacturer: Arthrex Device Name: Arthrex SwiveLock Suture Anchor 510(k) Number: K203495 Page 1 of 6… | 2021 |
| * | K221135 | X-Twist PEEK Suture AnchorSummary page 6…Additional Predicates: Manufacturer: Parcus Medical, LLC Device Name: X-Twist PEEK Suture Anchor 510(k) Number: K221135 Product Classification: Class II Regulation Number: 21 CFR 888.3040 Product Code: MBI… | 2022 |
| * | K212197 | WasherCap Fixation SystemSummary page 6…Code: MBI 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: MBI V.… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253618 | QuadLock™ Fixation System | 2026 | 0 |
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 46 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 14 of the 98 ancestors have a recall of any class.
- Of its descendants, K253618 (Abanza Tecnomed S.L, 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K203495.
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™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures: * Knee: - Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - ACL/PCL Repair…
Read the full statement (144 words)
WasherCap™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures:
* Knee:
- Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
- Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
- ACL/PCL Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
- ACL Reconstruction: only with WasherCap™ Mini Fixation System 4.5mm size and using 2 non-absorbable UHMWPE 1.4mm tapes or 1 non-absorbable UHMWPE 2.2mm tape.
* Shoulder:
- Rotator Cuff Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
* Hand/Wrist:
- Triangular fibrocartilage complex (TFCC): only with WasherCap™ Mini Fixation System 3.5mm size and using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
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/K243712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243712: WasherCap™ Mini Fixation System (Model 45).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243712
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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