# K203076: Mecta-C Stand Alone Extension

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Nov 6, 2020 after 24 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 259 ancestors in all.
No later device cites it as a predicate yet.
1 of 260 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192906: Mecta-C Stand Alone, Medacta International S.A. (2020) Summary page 4.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 4.

## Indications for use
The Mecta-C Stand Alone 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 for one level or two contiguous levels 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 interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K203076
Methodology: https://510kreport.com/methodology