West Chester, PA, US · 3 510(k) clearances · 19 PMAs · 6 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | Class II | Orthopedic | 3 | 2025-04-25 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-01-15 | P070001-S030 | prodisc® C | 30-Day Notice | MJO | — | — |
| 2025-10-10 | P070001-S025 | prodisc C SK and prodisc C Vivo | Panel Track | MJO | — | — |
| 2025-09-02 | P050010-S027 | PRODISC L | Normal 180 Day Track No User Fee | MJO | — | — |
| 2025-07-30 | P070001-S029 | prodisc® C | 30-Day Notice | MJO | — | — |
| 2025-07-30 | P050010-S028 | prodisc L | 30-Day Notice | MJO | — | — |
| 2025-06-04 | P070001-S028 | prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK | Normal 180 Day Track No User Fee | MJO | — | — |
| 2025-06-04 | P050010-S025 | PRODISC -L TOTAL DISC REPLACEMENT DEVICE | Normal 180 Day Track No User Fee | MJO | — | — |
| 2025-01-17 | P050010-S026 | prodisc® L | 30-Day Notice | MJO | — | — |
| 2024-08-07 | P070001-S027 | prodisc C | 30-Day Notice | MJO | — | — |
| 2024-03-01 | P070001-S026 | prodisc - C and prodisc - C Nova (Indicated for Single Level Use) | Special (Immediate Track) | MJO | — | — |
| 2023-11-08 | P070001-S024 | prodisc® C | Normal 180 Day Track No User Fee | MJO | — | — |
| 2023-11-08 | P050010-S024 | prodisc® L | Normal 180 Day Track No User Fee | MJO | — | — |
| 2022-07-07 | P070001-S019 | prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo | Normal 180 Day Track | MJO | — | — |
| 2021-10-28 | P070001-S021 | prodisc® C | 30-Day Notice | MJO | — | — |
| 2021-03-15 | P050010-S023 | prodisc L | 30-Day Notice | MJO | — | — |
| 2021-02-23 | P070001-S020 | prodisc C | 30-Day Notice | MJO | — | — |
| 2020-05-08 | P070001-S018 | prodisc C Total Disc Replacement | Normal 180 Day Track No User Fee | MJO | — | — |
| 2020-05-08 | P050010-S021 | prodisc L Total Disc Replacement | Normal 180 Day Track No User Fee | MJO | — | — |
| 2020-04-10 | P050010-S020 | prodisc L Total Disc Replacement | Panel Track | MJO | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-20 | Class II | Ongoing | Z-2051-2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement. | — | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was la… |
| 2026-03-20 | Class II | Ongoing | Z-2050-2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement. | — | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was la… |
| 2025-12-31 | Class II | Ongoing | Z-1426-2026 | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description… | — | Products were mislabeled as the 6mm product but included the 5 mm product. |
| 2024-07-18 | Class II | Ongoing | Z-3213-2024 | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 | — | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not hav… |
| 2024-07-18 | Class II | Ongoing | Z-3212-2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 | — | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not hav… |
| 2021-03-05 | Class II | Terminated | Z-1406-2021 | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction … | — | Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Sur… |