# K191311: ATEC Lateral Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Aug 12, 2019 after 89 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: 25 generations back to K841189 (1984). 409 ancestors in all.
78 later devices descend from it; 4 cite it directly.
1 of 488 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018) Summary page 4.
- K173892: NuVasive® XLX Interbody System, Nu Vasive, Incorporated (2018) Summary page 4.

## Most influential descendants
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K202587: ATEC Lateral Interbody System (2020), 39 descendants of its own
- K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (2021), 38 descendants of its own

## Indications for use
The ATEC Lateral Interbody 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 degenerative 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 Lateral Interbody 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. LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation in addition to supplemental fixation.

Source page: https://510kreport.com/device/K191311
Methodology: https://510kreport.com/methodology