510(k) · Cleared
ClearedSinefix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BAAT Medical Products B.V. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 8, 2023 as substantially equivalent to K200028 (Conextions Medical, 2020) after a 341-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Mar 8, 2023
- Review
- 341 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904436 (1990). 76 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations between
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- This deviceK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · cites it directly · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
Show all 10 generations
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 9 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 8 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 7 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 6 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 5 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 4 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- This deviceK220966 SinefixBAAT Medical Products B.V. · 2023
Most influential descendants
Showing 1 of 1 · See all- K254176SinefixBAAT Medical Products B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −9 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −8 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −7 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −6 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −5 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −4 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −3 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −2 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| −1 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| 0 (this device) | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +1 | K254176 | Sinefix | BAAT Medical Products B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K200028 | Coronet Soft Tissue Fixation SystemSummary page 4…sue Review Panel: Office of Health Technology 6: Orthopedic Devices 3. Predicate Device Primary Predicate: Coronet Soft Tissue Fixation System (K200028) Reference devices: Arthrex Tenodesis Screw Family (K051726) Acufex Spiked Washer System (K994202)… | 2020 |
| † | K051726 | Arthrex Tenodesis Family | 2005 |
| † | K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and… | 2000 |
| † | K062466 | Arthrex Interference Screw | 2006 |
| † | K162429 | ZipE Knotless Tissue Repair and Attachment Devices | 2017 |
| † | K983843 | Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B | 1999 |
| † | K123579 | Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL | 2013 |
| † | K101823 | Arthrex Swivelock Anchors | 2011 |
| † | K132783 | Exoshape Duo Soft Tissue Fastener | 2013 |
| † | K091870 | Tornier, Piton Fixation Implant System | 2009 |
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 |
|---|---|---|---|
| K254176 | Sinefix | 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 33 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 10 of the 76 ancestors have a recall of any class.
- Of its descendants, K254176 (BAAT Medical Products B.V., 2026) has gone furthest, with 0 descendants 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. 2023, 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?
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220966: Sinefix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220966
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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