# K202064: Admiral ACP System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Aug 26, 2020 after 30 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: 9 generations back to K922087 (1992). 34 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173521: SeaSpine Cabo ACP (Anterior Cervical Plate) System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K112206: Cardiff Anterior Cervical Plate System, Seaspine, Inc. (2012) Summary page 4.

## Most influential descendants
- K211903: Shoreline Threaded TruProfile® Plate (2021), 7 descendants of its own
- K212139: Admiral ACP System (2021), 6 descendants of its own
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own
- K252611: aprevo® cervical plating system (2025), 3 descendants of its own
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (2025), 3 descendants of its own

## Indications for use
The Admiral ACP 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/K202064
Methodology: https://510kreport.com/methodology
