# K231769: activL® Next Generation Instrumentation

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implants Systems, LLC
- Decided: Jul 13, 2023 after 27 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: 3 generations back to P200022 (2020). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220861: M6-C Artificial Cervical Disc Instruments AS, Spinal Kinetics, LLC (2022) Summary page 4.

## Indications for use
The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.

Source page: https://510kreport.com/device/K231769
Methodology: https://510kreport.com/methodology