# K152972: Amendia Stand-Alone Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Jan 14, 2016 after 98 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 108 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141005: Z-Link Cervical, Zavation, LLC (2014) Summary page 4.

## Most influential descendants
- K210044: Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (2021), 1 descendant of its own
- K230607: SPICCA Cervical Fusion Cages (2023), 0 descendants of its own
- K210382: Blustone Synergy Diamond SA Cervical System (2021), 0 descendants of its own

## Recalls of this device
- Jul 7, 2017 · Class II · Z-0316-2018: Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in 
- Nov 22, 2016 · Class II · Z-0966-2017: Absent tantalum market pin.

## Indications for use
The Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.

Source page: https://510kreport.com/device/K152972
Methodology: https://510kreport.com/methodology