# K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, LLC
- Decided: Aug 19, 2022 after 56 days
- Product code: QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices)
- Device class: 2
- Regulation: 21 CFR 888.4515
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P070001 (2007). 1 ancestor in all.
4 later devices descend from it; 3 cite 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)
- P070001: Prodisc TM-C Total Disc Replacement, Centinel Spine, LLC (2007) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.

Source page: https://510kreport.com/device/K221848
Methodology: https://510kreport.com/methodology