# K141993: Nakoma Acp

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Partners, LLC
- Decided: Nov 6, 2014 after 107 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922087 (1992). 23 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091134: Custom Spine Regent Anterior Cervical Plate, Custom Spine, Inc. (2009) Summary page 4.
- K100243: Quintex Cervical Plating System, Aesculap Implant Systems, LLC (2010) Summary page 4.

## Most influential descendants
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K173128: Alamo® C (2018), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Recalls of this device
- Jun 9, 2015 · Class II · Z-1989-2015: Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation

## Indications for use
The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications: • Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Trauma (including fractures) • Tumors • Deformities or curvatures (including kyphosis, lordosis or scoliosis) • Pseudoarthrosis • Failed previous fusions • Spondylolisthesis • Spinal Stenosis

Source page: https://510kreport.com/device/K141993
Methodology: https://510kreport.com/methodology