# K061294: KFX Knotless Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Kfx Medical
- Decided: Jul 19, 2006 after 71 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: 2 generations back to K003984 (2001). 6 ancestors in all.
19 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)
- K041713: Super Revo Herculine Suture Anchor, Linvatec Corp. (2004) Summary page 1.
- K041440: Opus Magnum Anchor with Inserter, Opus Medical, Inc. (2004) Summary page 1.
- K042914: Opus Magnum Knotless Anchor with Inserter Handle, Opus Medical, Inc. (2004) Summary page 1.
- K960516: Fastak Suture Anchor, Arthrex, Inc. (1996) Summary page 1.

## Most influential descendants
- K072063: KFX Tissue Fixation System and Accessories (2007), 18 descendants of its own
- K081598: Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce Suture (2008), 16 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own

## Indications for use
The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.

Source page: https://510kreport.com/device/K061294
Methodology: https://510kreport.com/methodology