# K192484: Fixone Biocomposite Anchor

- Pathway: 510(k) (Special)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Mar 11, 2020 after 183 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971358 (1997). 31 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171299: Fixone Biocomposite Anchor, Aju Pharm Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K203523: Fixone hybrid knotless anchor (2021), 1 descendant of its own
- K230892: Fixone Biocomposite Anchor (2023), 0 descendants of its own
- K212912: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (2021), 0 descendants of its own

## Indications for use
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Source page: https://510kreport.com/device/K192484
Methodology: https://510kreport.com/methodology