510(k) · Cleared
ClearedBio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Mar 12, 1999 as substantially equivalent to K974847 (Arthrex, Inc., 1998) after a 133-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 12, 1999
- Review
- 133 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974847 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974847 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM…Arthrex, Inc. · 1998
- This deviceK983843 Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238BArthrex, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974847 | 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute… | Arthrex, Inc. | 1998 | — |
| 0 (this device) | K983843 | Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B | Arthrex, Inc. | 1999 | — |
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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K974847 | 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture…Summary page 1…ator cuff tears. Similarities and Differences with Marketed Devices: The Bio-Button has the same diameter and thickness as the discs used with the Corkscrew Parachute (K974847). Furthermore, it is made out of the same material. There are slight variations in design, including removal of the cross and enl… | 1998 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K974847.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, utilizing the Arthrex® Corkscrew™ Suture Anchor and polyester braided sutures appropriate to the procedure, up to size 5 (single strand). This product is intended for use in repairing rotator cuff tears.
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/K983843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983843: Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983843
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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