TeKBrace Knotless Anchor

FDA 510(k) K253538 · Theramicro

Substantially Equivalent

510(k) numberK253538

Submission

Device name
TeKBrace Knotless Anchor
Applicant
Theramicro
Cordova, TN, US
Received
November 13, 2025
Decision date
March 6, 2026
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

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
K262729TeKBrace Solo Soft Tissue Reinforcement DeviceQUW · Special 08/18/2026SE
K261621TekBrace Solo Soft Tissue Reinforcement DeviceQUW · Special 06/09/2026SE
K251063TekBrace Solo Soft Tissue Reinforcement DeviceQUW · Traditional 05/30/2025SE

Questions and answers

When was TeKBrace Knotless Anchor cleared by the FDA?

TeKBrace Knotless Anchor (K253538) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 113 days after the submission was received.

What is the product code of K253538?

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