# K120024: Mectalif Transforaminal

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Feb 28, 2012 after 56 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: 12 generations back to K841189 (1984). 66 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110927: Mectalif, Medacta International (2011) Summary page 1.
- K040536: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 1.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 1.

## Most influential descendants
- K131671: Mectalif (2013), 22 descendants of its own
- K133192: Mectalif Tipeek (2014), 16 descendants of its own
- K142744: Mecta-C TiPEEK (2015), 12 descendants of its own
- K160605: MectaLIF Anterior Stand-Alone (2016), 10 descendants of its own
- K200551: MectaLIF Transforaminal TiPEEK (2021), 4 descendants of its own

## Indications for use
The MectaLiF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DOD) at one or two contiguous spinal levels from L2 - SI 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/K120024
Methodology: https://510kreport.com/methodology