# K080229: 5.5 MM Suture Lock Bone Screw Anchor

- Pathway: 510(k) (Special)
- Applicant: Kfx Medical
- Decided: Feb 29, 2008 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: 4 generations back to K003984 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072063: KFX Tissue Fixation System and Accessories, Kfx Medical (2007) Summary page 1.

## Indications for use
The KFx Tissue Fixation System (comprised of the KFx Suture Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and 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/K080229
Methodology: https://510kreport.com/methodology