APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS— 510(k) K133036

Clearance details

Applicant

Amendia, Inc.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2013-09-26

Decision date

2014-03-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fr. Myers, FL, 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

• K160924 — Amendia Interbody Fusion Devices2016-11-08
• K161842 — Overwatch Spine System2016-10-13
• K152920 — Savannah-T® Pedicle Screw System2016-07-08
• K153152 — Syzygy Stabilization System2016-04-27
• K160291 — Optimus ALIF System2016-02-18

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 →

• Z-0104-2019 — Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.Class II·Terminated·Valeris Medical, LLC·20180716

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133036.