# K243816: Testa TP Pivoting Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 27, 2025 after 197 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: 23 generations back to K841189 (1984). 344 ancestors in all.
No later device cites it as a predicate yet.
1 of 345 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100743: Atlas Spine Pivoting System, Atlas Spine, Inc. (2010) Summary page 5.
- K231275: Exceed™ Biplanar Expandable Interbody System, Spine Wave, Inc. (2023) Summary page 5.

## Indications for use
The Testa TM TP Pivoting Spacer System with TiCell@ Nano Advanced Surface Technology 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 Testa TM TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa TM TP Pivoting Spacer 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/K243816
Methodology: https://510kreport.com/methodology