A’TOMIC™ Nitinol Fixation System

FDA 510(k) K232990 · Rmr Ortho, LLC

Substantially Equivalent

510(k) numberK232990

Submission

Device name
A’TOMIC™ Nitinol Fixation System
Applicant
Rmr Ortho, LLC
Castroville, TX, US
Received
September 22, 2023
Decision date
January 12, 2024
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

510(k)DeviceApplicantDecision
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
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE
K232905Medline UNITE® REFLEX® Nitinol Staple KitJDR · Special Medline Industries, LP10/19/2023SE

Questions and answers

When was A’TOMIC™ Nitinol Fixation System cleared by the FDA?

A’TOMIC™ Nitinol Fixation System (K232990) received a 510(k) decision of Substantially Equivalent on January 12, 2024, 112 days after the submission was received.

What is the product code of K232990?

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