# K171893: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)

- Pathway: 510(k) (Traditional)
- Applicant: Bluestone Synergy
- Decided: Sep 8, 2017 after 74 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: 21 generations back to K841189 (1984). 204 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 207 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.
- K162264: Cascadia Interbody System, K2m, Inc. (2016) Summary page 4.
- K151819: Integrity Spine Lumbar Interbody Fusion System, Integrity Spine Lumbar Interbody Fusion System (2015) Summary page 4.

## Most influential descendants
- K210382: Blustone Synergy Diamond SA Cervical System (2021), 0 descendants of its own
- K203520: Blustone Synergy Interbody Fusion System (2021), 0 descendants of its own

## Indications for use
Blustone Synergy lumbar implants (Basalt, Magma, Obsidian): The Blustone Synergy lumbar 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 S1. 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. Blustone Synergy cervical implants (Slate): The Blustone Synergy cervical (Slate) 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. 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.

Source page: https://510kreport.com/device/K171893
Methodology: https://510kreport.com/methodology