# K212912: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Nov 4, 2021 after 52 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: 13 generations back to K911837 (1991). 124 ancestors in all.
No later device cites it as a predicate yet.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192484: Fixone Biocomposite Anchor, Aju Pharm Co., Ltd. (2020) Summary page 5.
- K192032: Fixone Biocomposite Small Anchor, Aju Pharm Co., Ltd. (2020) Summary page 5.
- K192709: Fixone All Suture Anchor, Aju Pharm Co., Ltd. (2020) Summary page 5.
- K193497: Fixone Biocomposite Interference Screw, Aju Pharm Co., Ltd. (2021) Summary page 5.
- K162070: Joinix Cannular System, Aju Pharm Co., Ltd. (2017) Summary page 5.

## Indications for use
The OneFix Biocomposite Anchors are intended for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor 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, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. The OneFix Biocomposite Small Anchors 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-Clavicular 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, Iliotibial 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 The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue. The OneFix Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. The OneFix Cannula System is intended for introduction of instrumentation through a portal for surgical procedure.

Source page: https://510kreport.com/device/K212912
Methodology: https://510kreport.com/methodology