# K990156: Multitak SS Buttons

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research
- Decided: Mar 5, 1999 after 45 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904436 (1990). 9 ancestors in all.
336 later devices descend from it; 2 cite it directly.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961522: Kirschner Wire (K-Wire) and Steinmann Pin, Synvasive Technology, Inc. (1996) Summary page 2.
- K973015: Multitak SS Suture System, Bonutti Research (1997) Summary page 2.
- K964532: Multitak SS Suture System, Bonutti Research (1997) Summary page 2.
- (no number) Ethicon, Inc. Polypropylene Buttons: named in the summary without a submission number

## Most influential descendants
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K990156
Methodology: https://510kreport.com/methodology