# K124034: Mectalif Anterior

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: May 17, 2013 after 140 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: 13 generations back to K841189 (1984). 90 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 1.
- K110927: Mectalif, Medacta International (2011) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.
- K071726: ZUMA, Seaspine, Inc. (2007) Summary page 1.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 1.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## 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 MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DOD) at one or two contiguous levels from L2 to SI. These DIDD 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 can be packed with autograft or autologous bone graft. DD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K124034
Methodology: https://510kreport.com/methodology