# K142101: Abacus (TM) Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Oct 23, 2014 after 83 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: 16 generations back to K003155 (2001). 139 ancestors in all.
No later device cites it as a predicate yet.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140007: Abacus TM Spacer System, Spine Wave, Inc. (2014) Summary page 4.
- K133205: Capstone PTC Spinal System, Clydesdale PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Indications for use
The Abacus™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) 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 DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Abacus™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K142101
Methodology: https://510kreport.com/methodology