# K242869: prodisc® L Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, LLC
- Decided: Dec 17, 2024 after 88 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: 2 generations back to P070001 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments, Centinel Spine, LLC (2022) Summary page 6.

## Most influential descendants
- K250554: prodisc® L Instruments (2025), 0 descendants of its own

## Indications for use
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

Source page: https://510kreport.com/device/K242869
Methodology: https://510kreport.com/methodology