# K120841: Appianfx Suture Anchor (6MM) (5MM) Appianfx Tissue Anchor

- Pathway: 510(k) (Special)
- Applicant: Kfx Medical
- Decided: Jun 7, 2012 after 79 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 PEEK Bone Anchor with Pro-Attached Sutures and Delivery Handle: named in the summary without a submission number

## Indications for use
The KFx APPIANFxTM PEEK Suture Anchors and APPIANFx TM PEEK Tissue Anchors 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, 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/K120841
Methodology: https://510kreport.com/methodology