# K140604: Multifix S Knotless Fixation System

- Pathway: 510(k) (Special)
- Applicant: ArthroCare Corporation
- Decided: May 14, 2014 after 65 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: 9 generations back to K961555 (1996). 23 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132590: 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device, Insertion Guide with Obturator, TA, ArthroCare Corporation (2013) Summary page 1.

## Most influential descendants
- K151660: MultiFIX S Knotless Fixation System (2015), 1 descendant of its own
- K153669: MultiFIX S Ultra Knotless Fixation System (2016), 0 descendants of its own

## Indications for use
The MultiFIX S is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair. acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reonstruction. and midfoot reconstruction Fool: Hallux vaigus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament orjoint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patcer ligament and tendon avulsions

Source page: https://510kreport.com/device/K140604
Methodology: https://510kreport.com/methodology