# K254202: MectaLIF 3D Metal Anterior

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 5, 2026 after 127 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: 20 generations back to K841189 (1984). 140 ancestors in all.
No later device cites it as a predicate yet.
1 of 141 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232123: MectaLIF Anterior Lag Extension, Medacta International S.A. (2023) Summary page 6.
- K124034: Mectalif Anterior, Medacta International (2013) Summary page 6.
- K160605: MectaLIF Anterior Stand-Alone, Medacta International (2016) Summary page 6.
- K170455: MectaLIF Anterior Stand Alone, Medacta International S.A. (2017) Summary page 6.
- K221545: MectaLIF Anterior Extension, Medacta International S.A. (2022) Summary page 6.

## Indications for use
The MectaLIF 3D Metal Anterior is an 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 3D Metal Anterior should 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF 3D Metal Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. MectaLIF 3D Metal Anterior with a lordotic angle greater than 20° will require additional supplemental fixation such as pedicle screws and rods. The MectaLIF Anterior is an 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 should 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.

Source page: https://510kreport.com/device/K254202
Methodology: https://510kreport.com/methodology