# K192906: Mecta-C Stand Alone

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 4, 2020 after 141 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: 17 generations back to K841189 (1984). 158 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 160 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112459: Synthes Zero-P, Synthes Spine Co.Lp (2011) Summary page 4.
- K124034: Mectalif Anterior, Medacta International (2013) Summary page 4.
- K160605: MectaLIF Anterior Stand-Alone, Medacta International (2016) Summary page 4.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 4.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 4.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.
- K133218: Crystal ®; Mosaic ®; Vertu ®, Spinal Elements, Inc. (2014) Summary page 4.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 4.

## Most influential descendants
- K203076: Mecta-C Stand Alone Extension (2020), 0 descendants of its own

## 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 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 interior of the spacer component of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K192906
Methodology: https://510kreport.com/methodology