Mesh, Surgical, Acetabular, Hip, Prosthesis
A surgical acetabular mesh is an implantable support structure used in hip arthroplasty to reinforce the acetabular cup or provide a scaffold for bone grafting in cases of severe acetabular bone deficiency, improving fixation and stability of the hip prosthesis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDJ, regulated under 21 CFR 878.3300, within the General and Plastic Surgery medical specialty. This device is an implant.
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Basic Information
- Product Code
- JDJ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Oct 22, 1997 | Substantially Equivalent | Link America, Inc. |
| K970957 | OSTEONICS RESTORATION ACETABULAR RING | Jun 03, 1997 | Substantially Equivalent | Osteonics Corp. |
| K963940 | EXETER MESH | Feb 13, 1997 | Substantially Equivalent | Howmedica, Inc. |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Sep 17, 1996 | Substantially Equivalent | Smith & Nephew Richards, Inc. |
| K962007 | PROTRUSION CAGES | Aug 01, 1996 | Substantially Equivalent | Depuy, Inc. |
| K925883 | OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS | Jun 15, 1993 | Substantially Equivalent | Osteonics Corp. |
| K890450 | INTERMEDICS APR(TM) II FEMORAL COMPONENT | Aug 09, 1989 | Substantially Equivalent for Some Indications | Intermedics Orthopedics |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.