# K203520: Blustone Synergy Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Blustone Synergy, LLC
- Decided: Apr 7, 2021 after 127 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). 353 ancestors in all.
No later device cites it as a predicate yet.
1 of 354 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171893: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate), Bluestone Synergy (2017) Summary page 6.
- K171075: Calix-C Cervical Interbody Spacer, X-Spine Systems, Inc. (2017) Summary page 6.
- K170119: Calix Lumbar Spinal Implant System, X-Spine Systems, Inc. (2017) Summary page 6.

## Indications for use
The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation. The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to Si. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K203520
Methodology: https://510kreport.com/methodology