dynaMX Compression Staple

FDA 510(k) K143622 · Mx Orthopedics, Corp.

Substantially Equivalent

510(k) numberK143622

Submission

Device name
dynaMX Compression Staple
Applicant
Mx Orthopedics, Corp.
Billerica, MA, US
Received
December 22, 2014
Decision date
June 17, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

Other 510(k)s with product code JDR

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K262451Arthrex DynaNite StaplesJDR · Traditional Arthrex, Inc.09/01/2026SE
K261121Megalodon Dynamic Compression SystemJDR · Traditional Paragon 28, Inc.08/06/2026SE
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
K240212COGNiTiON™ Staple SystemJDR · Special Ortho Solutions UK , Ltd.02/23/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE

More from Novastep

510(k)DeviceDecision
K161303dynaMX™ Compression PlateHRS · Traditional 01/26/2017SE
K160427dynaMX(TM) Nitinol Compression ScrewHWC · Traditional 06/03/2016SE
K153129dynaMX Tabbed StapleJDR · Traditional 01/28/2016SE

Questions and answers

When was dynaMX Compression Staple cleared by the FDA?

dynaMX Compression Staple (K143622) received a 510(k) decision of Substantially Equivalent on June 17, 2015, 177 days after the submission was received.

What is the product code of K143622?

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