# K082926: Zuma, Model 55-XXXX/56-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Dec 22, 2008 after 82 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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
No predicates in its family tree.
171 later devices descend from it; 3 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092521: ZUMA-C (2010), 168 descendants of its own
- K102547: Coroent Interlock System (2011), 131 descendants of its own
- K142299: CoRoent Small Interlock System (2014), 99 descendants of its own
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-51) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to LS) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period Additionally, Zuma is intended for use with bone graft.

Source page: https://510kreport.com/device/K082926
Methodology: https://510kreport.com/methodology