# K133192: Mectalif Tipeek

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jan 30, 2014 after 105 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: 14 generations back to K841189 (1984). 70 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 87 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.
- K131671: Mectalif, Medacta International (2013) Summary page 1.
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 2.

## Most influential descendants
- K142744: Mecta-C TiPEEK (2015), 12 descendants of its own
- K160605: MectaLIF Anterior Stand-Alone (2016), 10 descendants of its own
- K170455: MectaLIF Anterior Stand Alone (2017), 4 descendants of its own
- K221545: MectaLIF Anterior Extension (2022), 2 descendants of its own
- K181970: MectaLIF Posterior Extension (2018), 2 descendants of its own

## Indications for use
The MectaLiF implants in combination with supplemental fixation are indicated for use with autogenous bane 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/K133192
Methodology: https://510kreport.com/methodology