# K050813: Abc 2 Screw

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: May 4, 2005 after 34 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). 11 ancestors in all.
145 later devices descend from it; 3 cite it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 2.

## Most influential descendants
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 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.

Source page: https://510kreport.com/device/K050813
Methodology: https://510kreport.com/methodology