# K172587: Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Sep 18, 2017 after 21 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 16 generations back to K841189 (1984). 101 ancestors in all.
No later device cites it as a predicate yet.
1 of 102 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112862: Mecta-C, Medacta International (2011) Summary page 4.
- K142744: Mecta-C TiPEEK, Medacta International (2015) Summary page 4.

## Indications for use
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation. The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

Source page: https://510kreport.com/device/K172587
Methodology: https://510kreport.com/methodology