OIC Suture Anchor System— 510(k) K182736

Clearance details

Applicant

The Orthopaedic Implant Company

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2018-09-28

Decision date

2018-12-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reno, NV, US

• K253065 — Aevumed SUPERCYNCH Button System2026-09-02
• K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
• K262677 — Iconix Knotless T2026-08-27
• K262047 — Grappler Suture Anchor System2026-08-03
• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K242995 — OIC Small / Mini Fragment Plate System2024-10-23
• K181184 — OIC Intramedullary Nail System2018-07-27
• K160222 — OIC Cervical PEEK Spacer2016-12-07
• K113123 — OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM2012-01-12

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →