Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

FDA 510(k) K223114 · Gm Dos Reis Industria E Comerico Ltda.

Substantially Equivalent

510(k) numberK223114

Submission

Device name
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Applicant
Gm Dos Reis Industria E Comerico Ltda.
Campinas, BR
Received
October 3, 2022
Decision date
August 2, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

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K262809ArthroTAK Tendon Anchor KitMBI · Special ArthroTAK, LLC09/02/2026SE
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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.

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Questions and answers

When was Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors cleared by the FDA?

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors (K223114) received a 510(k) decision of Substantially Equivalent on August 2, 2023, 303 days after the submission was received.

What is the product code of K223114?

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