# K221545: MectaLIF Anterior Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 24, 2022 after 150 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 138 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 141 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.
- K160605: MectaLIF Anterior Stand-Alone, Medacta International (2016) Summary page 4.
- K170455: MectaLIF Anterior Stand Alone, Medacta International S.A. (2017) Summary page 4.
- K102738: Lanx Fusion System, Lanx, LLC (2011) Summary page 4.

## Most influential descendants
- K232123: MectaLIF Anterior Lag Extension (2023), 1 descendant of its own
- K254202: MectaLIF 3D Metal Anterior (2026), 0 descendants of its own

## Recalls of this device
- Mar 8, 2023 · Class II · Z-1400-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Mar 8, 2023 · Class II · Z-1404-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Mar 8, 2023 · Class II · Z-1402-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Mar 8, 2023 · Class II · Z-1401-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Mar 8, 2023 · Class II · Z-1405-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Mar 8, 2023 · Class II · Z-1403-2023: There is a potential for breakage of the small screw used to affix the anti-backout plate.

## Indications for use
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 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 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/K221545
Methodology: https://510kreport.com/methodology