Condylar Plate Fixation Implant
The Condylar Plate Fixation Implant is an orthopedic surgical implant used to stabilize and fix fractures or osteotomies at the condylar region of long bones, particularly the femur or humerus, by providing rigid internal fixation. It is classified as FDA Class 2 (moderate risk), meaning it is subject to general controls and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The product code is JDP, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device is flagged as an implant, reflecting its permanent or long-term placement within the body.
Basic Information
- Product Code
- JDP
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins | Mar 29, 2017 | Substantially Equivalent | DePuy Synthes |
| K110354 | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM | Mar 04, 2011 | Substantially Equivalent | SYNTHES USA |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.