510(k) · Cleared
ClearedMultitak SS Buttons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonutti Research · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 5, 1999 as substantially equivalent to K961522 (Synvasive Technology, Inc., 1996) and 2 other predicates after a 45-day review. Its family tree reaches back 3 generations to 1990. 336 later devices descend from it.
- Decided
- Mar 5, 1999
- Review
- 45 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904436 (1990). 9 ancestors in all. 336 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 2 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 1 generation backK973015 Multitak SS Suture SystemBonutti Research · 1997
- This deviceK990156 Multitak SS ButtonsBonutti Research · 1999
- Descendant · cites it directly · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
- Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · cites it directly · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
Showing 5 of 336 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 336 · See all- K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · cites it directly309descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
- K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · cites it directly161descendants
- K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 2 generations on143descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −2 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −1 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| 0 (this device) | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| +1 | K033717 | Transet Fracture Fixation System | Bonutti Research, Inc. | 2004 | — |
| +2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +1 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| +2 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 18 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 18 | 0 |
| 2018 | 15 | 0 |
| 2019 | 27 | 0 |
| 2020 | 24 | 0 |
| 2021 | 24 | 0 |
| 2022 | 25 | 0 |
| 2023 | 27 | 0 |
| 2024 | 35 | 0 |
| 2025 | 31 | 0 |
| 2026 | 37 | 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 |
|---|---|---|---|
| * | K961522 | Kirschner Wire (K-Wire) and Steinmann PinSummary page 2…to USP Size 2-0 Predicate Device: The Muititak SS Buttons are similar in intended use to Kirschner Wires and Steinmann Piny manufactured by Synvasive Technology, Inc. (K961522) and to Ethicon, Inc., Folypropyiene Bunions regulated as Class | surgical buttons. The Multitak SS Buttons are similar n design… | 1996 |
| * | K973015 | Multitak SS Suture SystemSummary page 2…ns regulated as Class | surgical buttons. The Multitak SS Buttons are similar n design and matenals to the Mulntak S STM devices manufactured by Bonutt: Research. Inc (K973015 and K964532)) Suture System soft tissue suture anchor Predicate Comparison; A chan comparing charactenistics of the The Multita… | 1997 |
| * | K964532 | Multitak SS Suture SystemSummary page 2…as Class | surgical buttons. The Multitak SS Buttons are similar n design and matenals to the Mulntak S STM devices manufactured by Bonutt: Research. Inc (K973015 and K964532)) Suture System soft tissue suture anchor Predicate Comparison; A chan comparing charactenistics of the The Multitak SS Buttons… | 1997 |
| * | — | Ethicon, Inc. Polypropylene Buttons Named without a submission number |
What descends from it? (336)
See all 3362 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K033717 (Bonutti Research, Inc., 2004) has gone furthest, with 309 descendants of its own.
- 2 other devices also cite its predicate K961522.
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.
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 Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and…
Read the full statement (186 words)
The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:
Multitak SS Button Size Button Material Maximum USP Suture Size
3.0 mm x 10.0 mm Ti-6A1-4V Up to USP Size 2
3.0 mm x 10.0 mm Polypropylene Up to USP Size 2
3.0 mm x 10.0 mm Ultra-high-molecular-weight
polyethylene (UHMWPE) Up to USP Size 2
2.5mmx 8.3 mm Ti-6Al4V Up to USP Size 2
25 mmx 8.3 mm Polypropylene Up to USP Size 1
2.5mmx 8.3 mm UHMWPE Up to USP Size 1
1.8 mm x 6.0 mm Ti-6A1-4V Up to USP Size 2
1.2 mm x 4.0 mm Ti-6Al-4V Up to USP Size 2-0
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/K990156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990156: Multitak SS Buttons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990156
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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