# K182746: ATEC ALIF and LLIF Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 27, 2018 after 60 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: 23 generations back to K841189 (1984). 300 ancestors in all.
110 later devices descend from it; 9 cite it directly.
1 of 411 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 4.
- K181453: ATEC ALIF Spacer System, Alphatec Spine, Inc. (2018) Summary page 4.
- K160958: Battalion Universal Spacer System, Alphatec Spine (2016) Summary page 4.
- K090782: Novel Alif Spinal Spacer System, Alphatec Spine, Inc. (2009) Summary page 4.
- K143740: Battalion Universal Spacer System, Alphatec Spine, Inc. (2015) Summary page 4.
- K101255: Alphatec Spine Anterior Lumbar Plating System, Alphatec Spine, Inc. (2010) Summary page 4.
- K163543: Biomet Fusion System, Zimmer Biomet Spine, Inc. (2017) Summary page 4.
- K173892: NuVasive® XLX Interbody System, Nu Vasive, Incorporated (2018) Summary page 4.
- K121791: Zou Anterior Lumbar Plate System, Corelink, LLC (2012) Summary page 4.
- K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System, Alphatec Spine, Inc. (2011) Summary page 4.

## Most influential descendants
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own

## Indications for use
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12. Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

Source page: https://510kreport.com/device/K182746
Methodology: https://510kreport.com/methodology