# K252611: aprevo® cervical plating system

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Dec 22, 2025 after 126 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K922087 (1992). 59 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212139: Admiral ACP System, SeaSpine Orthopedics Corporation (2021) Summary page 5.
- K210424: Quantum Anterior Cervical Plate, Nvision Biomedical Technologies, Inc. (2021) Summary page 5.
- K240690: STRUXXURE® MCS Anterior Cervical Plate System, Nexxt Spine (2024) Summary page 5.

## Most influential descendants
- K260570: corra™ cervical plating system (2026), 1 descendant of its own
- K262149: corra® cervical plating system (2026), 0 descendants of its own
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (2026), 0 descendants of its own

## Indications for use
The aprevo® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications: * Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), * Spondylolisthesis, * Trauma (i.e., fracture or dislocation), * Spinal stenosis, * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), * Tumor, * Pseudoarthrosis, and * Failed previous fusion.

Source page: https://510kreport.com/device/K252611
Methodology: https://510kreport.com/methodology