510(k) · Cleared
ClearedMultitak SS Suture System
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 Feb 3, 1997 after an 83-day review. The FDA summary names its predicate without a number. 394 later devices descend from it.
- Decided
- Feb 3, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
394 later devices descend from it, 2 citing it directly.
- This deviceK964532 Multitak SS Suture SystemBonutti Research · 1997
- Descendant · cites it directly · 393 of its ownK973015 Multitak SS Suture SystemBonutti Research · 1997
- Descendant · cites it directly · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
- Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
- Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
Showing 5 of 394 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 394 · See all- K973015Multitak SS Suture SystemBonutti Research · 1997 · cites it directly393descendants
- K990156Multitak SS ButtonsBonutti Research · 1999 · cites it directly336descendants
- K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964532 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| +1 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| +1 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| +2 | K033717 | Transet Fracture Fixation System | Bonutti Research, Inc. | 2004 | — |
| +3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 16 | 0 |
| 2014 | 19 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 22 | 0 |
| 2018 | 17 | 0 |
| 2019 | 30 | 0 |
| 2020 | 30 | 0 |
| 2021 | 28 | 0 |
| 2022 | 26 | 0 |
| 2023 | 32 | 0 |
| 2024 | 36 | 0 |
| 2025 | 34 | 0 |
| 2026 | 40 | 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 |
|---|---|---|---|
| * | — | Multitak SS Suture System Named without a submission number |
What descends from it? (394)
See all 3942 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?
- Of its descendants, K973015 (Bonutti Research, 1997) has gone furthest, with 393 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.
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 devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Rotator cuff tear repairs
- Biceps tenodesis
Foot and Ankle
- Lateral instability repairs/reconstructions
Elbow
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment
- Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
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/K964532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964532: Multitak SS Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964532
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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