# K110927: Mectalif

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jun 13, 2011 after 77 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 49 ancestors in all.
30 later devices descend from it; 9 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K040536: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.

## Most influential descendants
- K120024: Mectalif Transforaminal (2012), 23 descendants of its own
- K131671: Mectalif (2013), 22 descendants of its own
- K133192: Mectalif Tipeek (2014), 16 descendants of its own
- K112862: Mecta-C (2011), 14 descendants of its own
- K142744: Mecta-C TiPEEK (2015), 12 descendants of its own

## Recalls of this device
- Oct 21, 2014 · Class II · Z-0225-2015: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

## 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 (DDD) 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/K110927
Methodology: https://510kreport.com/methodology