# K181453: ATEC ALIF Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jul 25, 2018 after 54 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: 22 generations back to K841189 (1984). 209 ancestors in all.
111 later devices descend from it; 1 cites it directly.
0 of 321 devices in its family (counting itself) have 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.
- 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.
- K170962: NuVasive® CoRoent® Thoracolumbar System, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- 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

## Indications for use
The ATEC ALIF 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 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 or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Source page: https://510kreport.com/device/K181453
Methodology: https://510kreport.com/methodology