# K180480: ATEC Universal Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 31, 2018 after 97 days
- Product code: PHM (Intervertebral Fusion Device With Bone Graft, Thoracic)
- 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: 21 generations back to K841189 (1984). 207 ancestors in all.
113 later devices descend from it; 11 cite 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)
- K160958: Battalion Universal Spacer System, Alphatec Spine (2016) Summary page 4.
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 4.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K181453: ATEC ALIF Spacer System (2018), 111 descendants of its own
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 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

## Indications for use
The ATEC Universal 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 Universal 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 allograft or autograft (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/K180480
Methodology: https://510kreport.com/methodology