# K160605: MectaLIF Anterior Stand-Alone

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jul 21, 2016 after 141 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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). 131 ancestors in all.
10 later devices descend from it; 7 cite it directly.
1 of 142 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124034: Mectalif Anterior, Medacta International (2013) Summary page 4.
- K133192: Mectalif Tipeek, Medacta International (2014) Summary page 4.
- K142744: Mecta-C TiPEEK, Medacta International (2015) Summary page 4.
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 4.

## Most influential descendants
- 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
- K183426: MectaLIF Anterior Stand Alone Extension (2019), 1 descendant of its own

## Indications for use
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

Source page: https://510kreport.com/device/K160605
Methodology: https://510kreport.com/methodology