Apollo Suture Anchor System

FDA 510(k) K192810 · Valeris Medical

Substantially Equivalent

510(k) numberK192810

Submission

Device name
Apollo Suture Anchor System
Applicant
Valeris Medical
Marietta, GA, US
Received
October 1, 2019
Decision date
March 11, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MBI – Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MBI

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K262809ArthroTAK Tendon Anchor KitMBI · Special ArthroTAK, LLC09/02/2026SE
K253065Aevumed SUPERCYNCH™ Button SystemMBI · Traditional Aevumed, Inc.09/02/2026SE
K262677Iconix Knotless TMBI · Special Riverpoint Medical08/27/2026SE
K262047Grappler Suture Anchor SystemMBI · Special Paragon 28, Inc.08/03/2026SE
K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special Stryker Endoscopy07/30/2026SE
K261770Suture Button Repair SystemMBI · Traditional Skeletal Dynamics, Inc.07/29/2026SE
K261632Thunderbolt SystemMBI · Special Responsive Arthroscopy, Inc.07/20/2026SE
K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special Smith & Nephew, Inc.07/09/2026SE
K260018Arthrex FiberButtonMBI · Traditional Arthrex, Inc.06/26/2026SE
K253130Dione PEEK Screw SystemMBI · Traditional ZheJiang Decans Medical Devices Co., Ltd.05/27/2026SE

More from ZheJiang Decans Medical Devices Co., Ltd.

510(k)DeviceDecision
K193108Bonecam Suture AnchorMBI · Special 03/26/2020SE
K152255BoneCam Suture AnchorsMBI · Traditional 11/16/2015SE
K142230Apollo Suture Anchor System and Titan ScrewsMBI · Special 09/10/2014SE

Questions and answers

When was Apollo Suture Anchor System cleared by the FDA?

Apollo Suture Anchor System (K192810) received a 510(k) decision of Substantially Equivalent on March 11, 2020, 162 days after the submission was received.

What is the product code of K192810?

The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.