# K181435: ATEC Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Aug 21, 2018 after 81 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 354 ancestors in all.
100 later devices descend from it; 2 cite it directly.
1 of 455 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 4.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 4.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 4.
- K150362: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2015) Summary page 4.
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2014) Summary page 4.
- K120603: Varilift -C, Wenzel Spine (2013) Summary page 4.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) 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 Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K181435
Methodology: https://510kreport.com/methodology