# K251016: MectaLIF 3D Metal

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 17, 2025 after 106 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 17 generations back to K841189 (1984). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212831: MectaLIF Extension, Medacta International S.A. (2021) Summary page 5.
- K181970: MectaLIF Posterior Extension, Medacta International S.A. (2018) Summary page 5.
- K133192: Mectalif Tipeek, Medacta International (2014) Summary page 5.
- K131671: Mectalif, Medacta International (2013) Summary page 5.
- K110927: Mectalif, Medacta International (2011) Summary page 5.

## Indications for use
The MectalLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

Source page: https://510kreport.com/device/K251016
Methodology: https://510kreport.com/methodology