# K083609: KFX Peek Bone Anchor with Pre-Attached Sutures and Inserter Handle

- Pathway: 510(k) (Traditional)
- Applicant: Kfx Medical
- Decided: Mar 6, 2009 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KFx Knotless Fixation System: named in the summary without a submission number
- (no number) Arthrex Corkscrew FT Suture Anchor: named in the summary without a submission number
- (no number) Opus Magnum Anchor with-inserter: named in the summary without a submission number

## Indications for use
The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is 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/K083609
Methodology: https://510kreport.com/methodology