# K122336: Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MM

- Pathway: 510(k) (Traditional)
- Applicant: Eleven Blade Solutions, Inc.
- Decided: Jan 9, 2013 after 160 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: 4 generations back to K990088 (1999). 14 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K101045: Biomet Juggerknot. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132513: Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM /Bone Punch,2.8MM and Knot Pusher (2013), 6 descendants of its own
- K133727: Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and Obturator, 1.8MM & 2.8MM, Firstpass Sutu (2014), 5 descendants of its own
- K172165: Q-Fix Suture Anchor (2017), 4 descendants of its own
- 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 (2024), 1 descendant of its own
- 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 Eleven Blade Solutions, Inc., Q-FixTM' Suture Anchor System is intended to be used for Soft tissue to bone fixation for: Shoulder Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis Foot and Ankle Medial/lateral repair and reconstruction, Mid 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: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule Closure Hand and Wrist Collateral ligament repair. Sacpholunate ligament reconstruction, Tendlon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair

Source page: https://510kreport.com/device/K122336
Methodology: https://510kreport.com/methodology