# K182736: OIC Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: The Orthopaedic Implant Company
- Decided: Dec 28, 2018 after 91 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
Longest line of descent: 8 generations back to K961555 (1996). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113299: Rog Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 4.
- K173269: KATOR Suture Anchor, Kator, LLC (2018) Summary page 4.

## Indications for use
The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.

Source page: https://510kreport.com/device/K182736
Methodology: https://510kreport.com/methodology