# 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)

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 9, 2026 after 28 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 K990088 (1999). 19 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- 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, Smith & Nephew, Inc. (2024) Summary page 5.

## Indications for use
The Q-FIX◊ Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications: Shoulder: • 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

Source page: https://510kreport.com/device/K261968
Methodology: https://510kreport.com/methodology