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 Treace Medical Concepts.
FDA 510(k) Cleared Staple, Fixation, Bone Devices (Product Code JDR)
About Product Code JDR - Regulatory Context
510(k) Submission Activity
231 total 510(k) submissions under product code JDR since 1979, with 231 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under JDR have taken an average of 58 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
JDR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →