FDA Product Code JDR: Staple, Fixation, Bone
Staple fixation provides a low-profile alternative to screws in certain fracture patterns. FDA product code JDR covers bone fixation staples.
These U-shaped implants are driven across fracture lines or osteotomy sites to compress and stabilize bone segments. They are particularly used in foot and ankle surgery, small joint fusions, and procedures where a low-profile implant is preferred.
JDR devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medline Industries, LP, Paragon 28, Inc. and Medacta International S.A..
List of Staple, Fixation, Bone devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Staple, Fixation, Bone devices (product code JDR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →