# K072063: KFX Tissue Fixation System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Kfx Medical
- Decided: Oct 26, 2007 after 91 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: 3 generations back to K003984 (2001). 10 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061294: KFX Knotless Fixation System, Kfx Medical (2006) Summary page 2.
- K050358: Artherx Corkscrew FT II Suture Anchor, Arthrex, Inc. (2005) Summary page 2.
- K971723: Fastak Suture Anchor (11.7MM)/(7.5MM), Arthrex, Inc. (1997) Summary page 2.

## Most influential descendants
- 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
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own

## Indications for use
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs. Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair. Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair. Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

Source page: https://510kreport.com/device/K072063
Methodology: https://510kreport.com/methodology