# K122497: Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MM

- Pathway: 510(k) (Traditional)
- Applicant: Medical Design, LLC
- Decided: Oct 15, 2012 after 60 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 K926453 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K022344: Trinica Select Anterior Cervical Plate System, Centerpulse Spine-Tech, Inc. (2002) Summary page 1.

## Most influential descendants
- K143688: Asfora Anterior Cervical Plate System (2015), 0 descendants of its own

## Indications for use
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-TL) 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/K122497
Methodology: https://510kreport.com/methodology