# K092521: ZUMA-C

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Apr 13, 2010 after 238 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 4 generations back to K010530 (2001). 10 ancestors in all.
168 later devices descend from it; 3 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082309: Cambria, Seaspine, Inc. (2009) Summary page 1.
- K082926: Zuma, Model 55-XXXX/56-XXXX, Seaspine, Inc. (2008) Summary page 1.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 1.

## Most influential descendants
- 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
- K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical (2017), 61 descendants of its own

## Indications for use
Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K092521
Methodology: https://510kreport.com/methodology