Approval for simplify® cervical artificial disc that is indicated for use in skeletally mature patients for reconstruction of the disc at one level from c3-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e. G. , x-rays, computed tomography (ct), magnetic resonance imaging (mri)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving simplify® cervical artificial disc should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e. G. , numbness or tingling) prior to implantation. Simplify® cervical artificial disc is implanted via an open anterior approach.
| Device | Simplify® Cervical Artificial Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Simplify Medical, Inc. |
| Date Received | 2020-03-25 |
| Decision Date | 2020-09-18 |
| PMA | P200022 |
| Supplement | S |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200022 | Original Filing | |
| S008 | 2022-01-14 | 30-day Notice |
| S007 | 2021-06-25 | 30-day Notice |
| S006 | 2021-04-29 | Normal 180 Day Track No User Fee |
| S005 | 2021-04-28 | Normal 180 Day Track No User Fee |
| S004 | 2021-01-12 | 30-day Notice |
| S003 | ||
| S002 | 2020-10-07 | Normal 180 Day Track No User Fee |
| S001 |