# K142744: Mecta-C TiPEEK

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: May 7, 2015 after 225 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: 15 generations back to K841189 (1984). 100 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 113 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 5.
- K133192: Mectalif Tipeek, Medacta International (2014) Summary page 5.

## Most influential descendants
- K160605: MectaLIF Anterior Stand-Alone (2016), 10 descendants of its own
- K170455: MectaLIF Anterior Stand Alone (2017), 4 descendants of its own
- K221545: MectaLIF Anterior Extension (2022), 2 descendants of its own
- K232123: MectaLIF Anterior Lag Extension (2023), 1 descendant of its own
- K192906: Mecta-C Stand Alone (2020), 1 descendant of its own

## 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/K142744
Methodology: https://510kreport.com/methodology