# K140007: Abacus TM Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 7, 2014 after 95 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: 15 generations back to K841189 (1984). 26 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131071: Staxx Ibl System, Spine Wave, Inc. (2013) Summary page 1.
- K132719: Staxx Ibl System, Spine Wave, Inc. (2013) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- K152620: Spine Wave Gen II Expandable Interbody System (2016), 2 descendants of its own
- K162760: Spine Wave Anterior Cervical Spine System (2017), 1 descendant of its own
- K173175: Paramount Anterior Cervical Cage System (2017), 0 descendants of its own
- K142101: Abacus (TM) Spacer System (2014), 0 descendants of its own

## Indications for use
The AbacusTM Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The AbacusTM Spacer System isto be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nan-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K140007
Methodology: https://510kreport.com/methodology