510(k) · Cleared
ClearedCoronet Soft Tissue Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conextions Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 4, 2020 as substantially equivalent to K162429 (Ziptek, LLC, 2017) and 3 other predicates after a 58-day review. Its family tree reaches back 9 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 4, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K904436 (1990). 75 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- Descendant · cites it directly · 1 of its ownK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · 2 generations on · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 6 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 5 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 4 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −6 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −5 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −4 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −3 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −2 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| 0 (this device) | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| +1 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K162429 | ZipE Knotless Tissue Repair and Attachment DevicesSummary page 4…mon Name: Soft Tissue Fixation Device Classification Name: MBI (888.3040) Fastener, fixation, nondegradable, soft tissue Predicate Devices: K162429 ZipE Knotless Tissue Repair and Attachment Devices, Ziptek LLC. (Primary)… | 2017 |
| * | K070882 | Stryker Peek Twinloop TacSummary page 4…Predicate Devices: K162429 ZipE Knotless Tissue Repair and Attachment Devices, Ziptek LLC. (Primary) K070882 TwinLoopTM-PEEK Anchor, Stryker, Inc. K013806 Synthes® Metallic Spiked Washer, Depuy Synthes, Inc.… | 2007 |
| * | K013806 | Synthes Metallic Spiked WashersSummary page 4…nt Devices, Ziptek LLC. (Primary) K070882 TwinLoopTM-PEEK Anchor, Stryker, Inc. K013806 Synthes® Metallic Spiked Washer, Depuy Synthes, Inc. K130033 ToggleLocTM System, Zimmer Biomet, Inc… | 2002 |
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 4…K070882 TwinLoopTM-PEEK Anchor, Stryker, Inc. K013806 Synthes® Metallic Spiked Washer, Depuy Synthes, Inc. K130033 ToggleLocTM System, Zimmer Biomet, Inc. Device Description The Coronet Soft Tissue Fixation System consists of a single-… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220966 | Sinefix | 2023 | 1 |
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 6 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 75 ancestors have a recall of any class.
- Of its descendants, K220966 (BAAT Medical Products B.V., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162429.
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. 2020, 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?
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction…
Read the full statement (104 words)
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200028: Coronet Soft Tissue Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200028
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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