# K040017: Abc Caudal and Cranial Extension Plate (E-Plate)

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: May 14, 2004 after 129 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: 3 generations back to K922087 (1992). 12 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 1.
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 1.
- K992344: Osteonics Accp System Line Extension, Howmedica Osteonics Corp. (1999) Summary page 2.
- K993181: Howmedica Osteonics Accp System Cortical Screws, Howmedica Osteonics Corp. (1999) Summary page 2.

## Most influential descendants
- K100243: Quintex Cervical Plating System (2010), 10 descendants of its own
- K141993: Nakoma Acp (2014), 8 descendants of its own
- 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

## Indications for use
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies)., trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

Source page: https://510kreport.com/device/K040017
Methodology: https://510kreport.com/methodology