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 16, 2026 as substantially equivalent to K220966 (BAAT Medical Products B.V., 2023) after an 83-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Mar 16, 2026
- Review
- 83 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K904436 (1990). 77 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations between
- 3 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 2 generations backK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- 1 generation backK220966 SinefixBAAT Medical Products B.V. · 2023
- This deviceK254176 SinefixBAAT Medical Products B.V. · 2026
Show all 11 generations
- Root · 11 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 10 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 9 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 8 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 7 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 6 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 5 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 4 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 3 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 2 generations backK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- 1 generation backK220966 SinefixBAAT Medical Products B.V. · 2023
- This deviceK254176 SinefixBAAT Medical Products B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −10 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −9 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −8 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −7 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −6 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −5 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −4 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −3 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| −2 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| −1 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220966 | SinefixSummary page 5…le, Soft Tissue Review Panel: Office of Health Technology 6: Orthopedic Devices 3. Predicate Device SINEFIX (K220966) 4. Description of the Device The SINEFIX is a PEEK implant which can be used to fixate soft tissue to bone. The implant can… | 2023 |
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 36 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 10 of the 77 ancestors have a recall of any class.
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. 2026, 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 SINEFIX is intended for fixation of soft tissue to bone. The SINEFIX is intended for the following indications:
o Shoulder: Rotator Cuff Repairs, Deltoid Repair.
o Foot/Ankle: Achilles Tendon Repair.
o Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Quadriceps Tendon Rupture Repair.
o Elbow: Biceps Tendon Reattachment. Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
o Hip: Gluteus Medius repair, Gluteus Minimus repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254176: Sinefix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254176
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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