COGNiTiON™ Staple System

FDA 510(k) K240212 · Ortho Solutions UK , Ltd.

Substantially Equivalent

510(k) numberK240212

Submission

Device name
COGNiTiON™ Staple System
Applicant
Ortho Solutions UK , Ltd.
Maldon, GB
Received
January 25, 2024
Decision date
February 23, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDR – Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K262451Arthrex DynaNite StaplesJDR · Traditional Arthrex, Inc.09/01/2026SE
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K250712Linkt Compression Staple SystemJDR · Traditional Trax Surgical05/14/2025SE
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional Medline Industries, LP04/11/2025SE
K243742Arthrex DynaNite Nitinol StaplesJDR · Traditional Arthrex, Inc.01/31/2025SE
K243658TMC Compression Implant SystemJDR · Special Treace Medical Concepts12/26/2024SE
K242415TMC Compression Implant SystemJDR · Special Treace Medical Concepts09/06/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE
K232905Medline UNITE® REFLEX® Nitinol Staple KitJDR · Special Medline Industries, LP10/19/2023SE

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Questions and answers

When was COGNiTiON™ Staple System cleared by the FDA?

COGNiTiON™ Staple System (K240212) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 29 days after the submission was received.

What is the product code of K240212?

The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.