# P070001: Prodisc TM-C Total Disc Replacement

- Pathway: PMA
- Applicant: Centinel Spine, LLC
- Decided: Dec 17, 2007 after 348 days
- Product code: MJO (Prosthesis, Intervertebral Disc)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (2022), 4 descendants of its own
- K242869: prodisc® L Instruments (2024), 1 descendant of its own
- K262639: BAGUERA® C Cervical Disc Surgical Instruments (2026), 0 descendants of its own
- K253392: Synergy Disc Instruments (2026), 0 descendants of its own
- K250554: prodisc® L Instruments (2025), 0 descendants of its own

## Recalls of this device
- Mar 20, 2026 · Class II · Z-2050-2026: 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 labeled as a 6mm.
- Mar 20, 2026 · Class II · Z-2051-2026: 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 labeled as a 6mm.
- Dec 31, 2025 · Class II · Z-1426-2026: Products were mislabeled as the 6mm product but included the 5 mm product.
- Mar 5, 2021 · Class II · Z-1406-2021: 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 Surgical Technique, the "UP" is one of the 

Source page: https://510kreport.com/device/P070001
Methodology: https://510kreport.com/methodology