MectaLIF Posterior Interbody Fusion Device

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK110927	Date13 Jun 2011Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K110927

Recalls

1 recall · FDA

- Terminated Z-0225-2015 FDA Class II initiated 21 Oct 2014
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Timeline

2 dated events

13 Jun 2011 Cleared FDA 510(k) K110927
21 Oct 2014 Recall initiated FDA recalls Z-0225-2015

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K110927
FDA product code: MAX

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Clydesdale Spinal System K100175 2 Jun 2010 FDA record · FDA summary
Depuy Spine Bengal, Concorde, Cougar, Devex And Leopard Systems K081917 22 May 2009 FDA record
Capstone Spinal System K073291 24 Apr 2008 FDA record
Oracle Spacer, Opal Spacer K072791 26 Dec 2007 FDA record
Modification To Verte-Stack Spinal System K040536 5 May 2004 FDA record

Cited by

MectaLIF 3D Metal K251016 17 Jul 2025 FDA record · FDA summary
MectaLIF Extension K212831 29 Oct 2021 FDA record · FDA summary
Peridot Intervertebral body fusion System K192026 26 Nov 2019 FDA record · FDA summary
MectaLIF Posterior Extension K181970 4 Dec 2018 FDA record · FDA summary
TELIX K Interbody System K170890 2 Jun 2017 FDA record · FDA summary
Mectalif Tipeek K133192 30 Jan 2014 FDA record · FDA summary
Mectalif K131671 5 Jul 2013 FDA record · FDA summary
Mectalif Anterior K124034 17 May 2013 FDA record · FDA summary
Mectalif Transforaminal K120024 28 Feb 2012 FDA record · FDA summary
Mecta-C K112862 19 Dec 2011 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

MectaLIF is a posterior interbody fusion device made of PEEK and titanium-coated PEEK, designed for solid initial fixation and long-term spine stabilization. It features anatomic shaping to address unique patient needs and offers biocompatibility as part of the Medacta MectaLIF System.

The device is supplied as a modular system that allows surgeons to assemble available plates intraoperatively to accommodate specific anatomical requirements and pathologies. It is intended for use in spinal fusion procedures and is regulated under FDA 510(k) authorization with product code MAX. The device is single-use and should be stored in a dry, sterile environment prior to use.

Devices cleared under K110927

33 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K110927
		UDI-DI	Size and differences
Mectalif Oblique Cages 03.20.001 Medacta International SA	03.20.001	07630030827242	—	On the market
Mectalif Oblique Cages 03.20.002 Medacta International SA	03.20.002	07630030827259	—	On the market
Mectalif Oblique Cages 03.20.003 Medacta International SA	03.20.003	07630030827266	—	On the market
Mectalif Oblique Cages 03.20.004 Medacta International SA	03.20.004	07630030827273	—	On the market
Mectalif Oblique Cages 03.20.005 Medacta International SA	03.20.005	07630030827280	—	On the market
Mectalif Oblique Cages 03.20.006 Medacta International SA	03.20.006	07630030827297	—	On the market
Mectalif Oblique Cages 03.20.007 Medacta International SA	03.20.007	07630030827303	—	On the market
Mectalif Oblique Cages 03.20.008 Medacta International SA	03.20.008	07630030827310	—	On the market
Mectalif Oblique Cages 03.20.009 Medacta International SA	03.20.009	07630030827327	—	On the market
Mectalif Oblique Cages 03.20.010 Medacta International SA	03.20.010	07630030827334	—	On the market
Mectalif Oblique Cages 03.20.011 Medacta International SA	03.20.011	07630030827341	—	On the market
Mectalif Oblique Cages 03.20.012 Medacta International SA	03.20.012	07630030827358	—	On the market
Mectalif Oblique Cages 03.20.013 Medacta International SA	03.20.013	07630030827365	—	On the market
Mectalif Oblique Cages 03.20.014 Medacta International SA	03.20.014	07630030827372	—	On the market
Mectalif Oblique Cages 03.20.015 Medacta International SA	03.20.015	07630030827389	—	On the market
Mectalif Oblique Cages 03.20.016 Medacta International SA	03.20.016	07630030827396	—	On the market
Mectalif Oblique Cages 03.20.017 Medacta International SA	03.20.017	07630030827402	—	On the market
Mectalif Oblique Cages 03.20.018 Medacta International SA	03.20.018	07630030827419	—	On the market
Mectalif Oblique Cages 03.20.019 Medacta International SA	03.20.019	07630030827426	—	On the market
Mectalif Oblique Cages 03.20.020 Medacta International SA	03.20.020	07630030827433	—	On the market
Mectalif Oblique Cages 03.20.021 Medacta International SA	03.20.021	07630030827440	—	On the market
Mectalif Oblique Cages 03.20.022 Medacta International SA	03.20.022	07630030827457	—	On the market
Mectalif Oblique Cages 03.20.023 Medacta International SA	03.20.023	07630030827464	—	On the market
Mectalif Oblique Cages 03.20.024 Medacta International SA	03.20.024	07630030827471	—	On the market
Mectalif Oblique Cages 03.20.025 Medacta International SA	03.20.025	07630030827488	—	On the market
Mectalif Oblique Cages 03.20.026 Medacta International SA	03.20.026	07630030827495	—	On the market
Mectalif Oblique Cages 03.20.027 Medacta International SA	03.20.027	07630030827501	—	On the market
Mectalif Oblique Cages 03.20.028 Medacta International SA	03.20.028	07630030827518	—	On the market
Mectalif Oblique Cages 03.20.029 Medacta International SA	03.20.029	07630030827525	—	On the market
Mectalif Oblique Cages 03.20.030 Medacta International SA	03.20.030	07630030827532	—	On the market
Mectalif Oblique Cages 03.20.031 Medacta International SA	03.20.031	07630030827549	—	On the market
Mectalif Oblique Cages 03.20.032 Medacta International SA	03.20.032	07630030827556	—	On the market
Mectalif Oblique Cages 03.20.033 Medacta International SA	03.20.033	07630030827563	—	On the market

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Regulatory status

Recalls

Timeline

Coverage

Specification

Related clearances

Cites

Cited by

Overview

Devices cleared under K110927

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