# K231275: Exceed™ Biplanar Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jul 25, 2023 after 84 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: 22 generations back to K841189 (1984). 339 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153222: Leva Spacer System, Spine Wave, Inc. (2016) Summary page 4.
- K222203: DualXSLIM (R) T/PLIF, Amplify Surgical, Inc. (2022) Summary page 4.

## Most influential descendants
- K261159: Exceed® Biplanar Expandable Interbody System (2026), 0 descendants of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own

## Indications for use
The ExceedTM Biplanar Expandable Interbody 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-S1. 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 ExceedTM Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The ExceedTM Biplanar Expandable Interbody System is to be used 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/K231275
Methodology: https://510kreport.com/methodology