# K192032: Fixone Biocomposite Small Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Mar 3, 2020 after 217 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 K961555 (1996). 12 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140855: Arthrex Suturetak Suture Anchors, Arthrex, Inc. (2014) Summary page 4.

## Most influential descendants
- K202806: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (2021), 2 descendants of its own
- K231326: Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching) (2023), 1 descendant of its own
- K243467: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (2024), 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 Small Anchor are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

Source page: https://510kreport.com/device/K192032
Methodology: https://510kreport.com/methodology