# K241435: Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 20, 2024 after 30 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: 8 generations back to K990088 (1999). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172165: Q-Fix Suture Anchor, ArthroCare Corporation (2017) Summary page 6.

## Most influential descendants
- K261968: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (2026), 0 descendants of its own

## Indications for use
The Q-FIXO Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications: Shoulder: * Bankart lesion repair * SLAP lesion repair * Acromio-clavicular repair * Capsular shift/capsulolabral reconstruction * Deltoid repair * Rotator cuff tear repair * Biceps tenodesis Foot & Ankle: * Medial/Lateral repair and reconstruction * Midfoot and forefoot repair * Hallux valgus reconstruction * Metatarsal ligament/tendon repair or reconstruction *Achilles tendon repair Elbow: * Ulnar or radial collateral ligament reconstruction * Lateral epicondylitis repair * Biceps tendon reattachment Knee: * Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament * Iliotibial band tenodesis (IBT) * Patellar tendon repair * Vastus medialis obliquus advancement (VMO) * Joint capsule closure Hip: *Acetabular labral repair

Source page: https://510kreport.com/device/K241435
Methodology: https://510kreport.com/methodology